Phase 2 Study of Paclitaxel (NSC #673089) + Ipatasertib (NSC #781451) in Taxane-Refractory Participants With AKT-Altered Advanced Non-Breast Solid Tumors: A ComboMATCH Treatment Trial

This phase II ComboMATCH treatment trial tests the usual treatment of chemotherapy (paclitaxel) plus ipatasertib in patients with solid tumor cancers that that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced) or from where it first started (primary site) to other places in the body (metastatic), and has an AKT genetic change. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Targeted therapy, such as Ipatasertib, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of ipatasertib to paclitaxel in solid tumors with an AKT genetic change could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression). Researchers hope to learn if paclitaxel plus ipatasertib will shrink this type of cancer or stop its growth.

Start Date22 Sep 2023

Sponsor / Collaborator

National Cancer Institute

NCT05332561 / RecruitingPhase 2

Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer - a Multicenter, Open-label, Umbrella Phase-II Study - COGNITION-GUIDE

In early breast cancer (eBC), pathological complete response (pCR) after neoadjuvant therapy acts as surrogate marker for metastasis and overall survival. Therapy intensification by adding an adjuvant therapy line (post-neoadjuvant treatment) substantially lowers the risk of relapse in high-risk breast cancer patients with residual disease after neoadjuvant treatment (non-pCR). While this approach was exemplified in two phase III trials without biomarker-stratification (CREATE-X, KATHERINE), even higher efficiency might be achieved by individualized genomic-guided post-neoadjuvant therapies.
Within the seven-arm umbrella phase-II clinical trial COGNITION-GUIDE, we aim to deliver molecularly-tailored cancer care by implementing an additional response- and genomics-guided post-neoadjuvant therapy after finishing the guideline-compliant post-neoadjuvant treatment in high-risk breast cancer patients with residual cancer burden after neoadjuvant therapy to reduce the substantial risk of local and distant relapse.
The trial evaluates not a single drug but rather a general strategy of precision oncology in the curative setting and provides the basis for future confirmatory biomarker-driven trials.
Allocation to the therapy-arms is conducted by in depth molecular characterization of tumors within the COGNITION registry program.
The study aims to show an overall benefit of the precision medicine approach in high-risk eBC patients and to allow for secondary exploratory evaluation of each study-arm.
The primary endpoint of the study is invasive Disease-Free Survival (IDFS) after 4 years measured from surgery to local or distant relapse or death. The sample size of the entire trial is 240 eligible patients.

Start Date29 Jun 2023

Sponsor / Collaborator

German Cancer Research Center

NCT05862285 / RecruitingPhase 3

An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study

The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP[s]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally.

Start Date01 Jun 2023

Sponsor / Collaborator

F. Hoffmann-La Roche Ltd.

100 Clinical Results associated with Ipatasertib Dihydrochloride

100 Translational Medicine associated with Ipatasertib Dihydrochloride

100 Patents (Medical) associated with Ipatasertib Dihydrochloride

110

Literatures (Medical) associated with Ipatasertib Dihydrochloride

12 Dec 2023·Annals of medicine

Ipatasertib, an oral AKT inhibitor, in combination with carboplatin exhibits anti-proliferative effects in uterine serous carcinoma

Article

Author: Deng, Boer ; Newton, Meredith A. ; Zhao, Ziyi ; Sun, Wenchuan ; Bae-Jump, Victoria ; Zhou, Chunxiao ; Secord, Angeles Alvarez ; Burkett, Wesley C.

PURPOSE:

Uterine serous carcinoma (USC) exhibits worse survival rates compared to the endometrioid subtype, and there is currently no effective treatment options for recurrence of this disease after platinum-based chemotherapy. Activation of PIK3CA/AKT/mTOR signaling pathway is a common biological feature in USC.

MATERIALS AND METHODS:

Ipatasertib (IPAT) is an investigational, orally administered, ATP-competitive, highly selective inhibitor of pan AKT that has demonstrated anti-proliferative activity in a variety of tumor cells and tumor models. In this study, we used IPAT, carboplatin and their combination to investigate the anti-tumor activity in SPEC-2 and ARK-1 cells.

RESULTS:

Our results indicate that IPAT combined with carboplatin at low doses was more effective at reducing proliferation, inducing apoptosis and causing cellular stress than IPAT or carboplatin alone. In particular, inhibition of the PIK3CA/AKT/mTOR pathway and induction of DNA damage were involved in the synergistic inhibition by combination treatment of cell viability in USC cells treated with the combination. Furthermore, IPAT in combination with carboplatin significantly reduced cell adhesion and inhibited cell invasion.

CONCLUSIONS:

These findings suggest that the combination of IPAT and carboplatin has potential clinical implications for developing new USC treatment strategies.

01 Oct 2023·Drug metabolism and disposition: the biological fate of chemicals

The Absolute Bioavailability and Absorption, Metabolism, and Excretion of Ipatasertib, a Potent and Highly Selective Protein Kinase B (Akt) Inhibitor.

Article

Author: Kshirsagar, Smita ; Musib, Luna ; Sane, Rucha ; Malhi, Vikram ; Deng, Yuzhong ; Ma, Shuguang ; Cho, Sungjoon ; Dean, Brian ; Liederer, Bianca M ; Al-Sayah, Mohammad A ; Nugteren, James ; Takahashi, Ryan H ; Yost, Edward

Ipatasertib (GDC-0068) is a potent, highly selective, small-molecule inhibitor of protein kinase B (Akt) being developed by Genentech/Roche as a single agent and in combination with other therapies for the treatment of cancers. To fully understand the absorption, metabolism, and excretion of ipatasertib in humans, an open-label study using ¹⁴C-radiolabeled ipatasertib was completed to characterize the absolute bioavailability (period 1) and mass balance and metabolite profiling (period 2). In period 1, subjects were administered a 200 mg oral dose of ipatasertib followed by an 80 μg (800 nCi) intravenous dose of [¹⁴C]-ipatasertib. In period 2, subjects received a single oral dose containing approximately 200 mg (100 μCi) [¹⁴C]-ipatasertib. In an integrated analytical strategy, accelerator mass spectrometry was applied to measure the ¹⁴C microtracer intravenous pharmacokinetics in period 1 and fully profile plasma radioactivity in period 2. The systemic plasma clearance and steady-state volume of distribution were 98.8 L/h and 2530 L, respectively. The terminal half-lives after oral and intravenous administrations were similar (26.7 and 27.4 hours, respectively) and absolute bioavailability of ipatasertib was 34.0%. After a single oral dose of [¹⁴C]-ipatasertib, 88.3% of the administered radioactivity was recovered with approximately 69.0% and 19.3% in feces and urine, respectively. Radioactivity in feces and urine was predominantly metabolites with 24.4% and 8.26% of dose as unchanged parent, respectively; indicating that ipatasertib had been extensively absorbed and hepatic metabolism was the major route of clearance. The major metabolic pathway was N-dealkylation mediated by CYP3A, and minor pathways were oxidative by cytochromes P450 and aldehyde oxidase. SIGNIFICANCE STATEMENT: The study provided definitive information regarding the absolute bioavailability and the absorption, metabolism, and excretion pathways of ipatasertib, a potent, novel, and highly selective small-molecule inhibitor of protein kinase B (Akt). An ultrasensitive radioactive counting method, accelerator mass spectrometry was successfully applied for ¹⁴C-microtracer absolute bioavailability determination and plasma metabolite profiling.

14 Sep 2023·Blood

DLBCL-associated NOTCH2 mutations escape ubiquitin-dependent degradation and promote chemoresistance.

Article

Author: Busino, Luca ; Wan, Liling ; Shi, Junwei ; Ruella, Marco ; Inamdar, Arati ; Perkey, Eric ; Zhou, Nan ; Maillard, Ivan ; Kim, Bang-Jin ; Tang, Hsin-Yao ; Cao, Zhendong ; Ren, Diqiu ; Choi, Jaewoo ; Liu, Yiman ; Li, Qinglan ; Beer, Thomas ; Bonasio, Roberto ; Grothusen, Grant

Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma. Up to 40% of patients with DLBCL display refractory disease or relapse after standard chemotherapy treatment (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]), leading to significant morbidity and mortality. The molecular mechanisms of chemoresistance in DLBCL remain incompletely understood. Using a cullin-really interesting new gene (RING) ligase-based CRISPR-Cas9 library, we identify that inactivation of the E3 ubiquitin ligase KLHL6 promotes DLBCL chemoresistance. Furthermore, proteomic approaches helped identify KLHL6 as a novel master regulator of plasma membrane-associated NOTCH2 via proteasome-dependent degradation. In CHOP-resistant DLBCL tumors, mutations of NOTCH2 result in a protein that escapes the mechanism of ubiquitin-dependent proteolysis, leading to protein stabilization and activation of the oncogenic RAS signaling pathway. Targeting CHOP-resistant DLBCL tumors with the phase 3 clinical trial molecules nirogacestat, a selective γ-secretase inhibitor, and ipatasertib, a pan-AKT inhibitor, synergistically promotes DLBCL destruction. These findings establish the rationale for therapeutic strategies aimed at targeting the oncogenic pathway activated in KLHL6- or NOTCH2-mutated DLBCL.

News (Medical) associated with Ipatasertib Dihydrochloride

02 Jun 2024

·www.prnewswire.com

MEDSIR's PRIMED Study Shows Promising Results for Preventing Sacituzumab Govitecan related Side Effects in the Treatment of HER2-negative Advanced Breast Cancer

The PRIMED study found a way to reduce treatment-related side effects among participants, decreasing dose reductions, treatment interruptions, and permanent discontinuations. The strategic alliance between MEDSIR and Oncoclínicas has enabled the company to present 13 studies at the 2024 ASCO Annual Meeting. CHICAGO, June 2, 2024 /PRNewswire/ -- Leading international medical research company, MEDSIR, today announced the results of the recent PRIMED clinical trial during the 2024 ASCO Annual Meeting. Carried out under the company's collaborative model, this Investigator-Initiated Trial (IIT) demonstrated the effectiveness of preventative administration of drugs to treat the common side effects of neutropenia and diarrhea that can occur while taking sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2 that has extended overall survival for patients with pretreated triple negative and HR-positive/HER2-negative advanced breast cancer in two previous Phase 3 studies, ASCENT and TROPiCS-02. In the PRIMED study, adding primary prophylactic granulocyte colony-stimulating growth factors (G-CSF) and loperamide during the first two sacituzumab govitecan treatment cycles led to clinically meaningful reductions in neutropenia and diarrhea, lowering the need for dose reductions, treatment interruptions, and permanent discontinuations. Continue Reading Dr. Antonio Llombart-Cussac and Dr. Javier Cortés at ASCO24 Dr. Antonio Llombart-Cussac and Dr. Javier Cortés at ASCO "This is an exciting finding that highlights the high potential of prophylactic strategies that can mitigate side effects to help keep patients on promising treatments, which was made possible by our collaborative research model," shared Dr. Antonio Llombart-Cussac, Senior Scientific Leader of MEDSIR. "By using a partnership model that combines the benefits of company-sponsored research with all the advantages of IITs, we are turning brilliant ideas into full clinical trials that will safely and efficiently advance cancer solutions. It is our hope that, by working together, we will continue to generate new opportunities for patients worldwide." Among PRIMED study participants, the incidence of any grade of neutropenia (in the first two cycles) was 28%, compared to 63% and 70% in ASCENT and TROPiCS-02 (in the full study), respectively. The incidence of any grade diarrhea (in the first two cycles) was 34%, compared to 59% and 57% in ASCENT and TROPiCS-02 (in the full study), respectively. The other side effects PRIMED study participants experienced were consistent to the known safety profile of sacituzumab govitecan, with the exception of constipation, which occurred in 46% of patients during the first two cycles compared to 17% in ASCENT and 19% in TROPiC-02 (in the full study). However, most cases of constipation were mild, and no patients experienced adverse events that led to permanent treatment discontinuation. The study, which is still ongoing to evaluate efficacy and collect longer-term safety data, enrolled 50 patients between February 2023 and September 2023 across 10 sites across Spain, providing them with G-CSF and loperamide during the first two sacituzumab govitecan treatment cycles (physician's decision to continue after two cycles). These two drugs are commonly used to treat neutropenia and diarrhea, respectively, but are usually administered only after these side effects occur. In PRIMED, researchers wanted to test whether early administration of these drugs, before patients experienced any neutropenia or diarrhea, could reduce the incidence of these side effects and determine how this affected the need for dose reductions, treatment interruptions, and permanent discontinuations. Showcasing Numerous Promising Collaborative Trials at ASCO PRIMED was not the only trial MEDSIR presented during the ASCO Annual Meeting. It shared the results of several other recent and ongoing studies as well. Recently published in The Lancet, MEDSIR's PHERGain phase II trial (NCT03161353) demonstrated how a third of patients with HER2-positive early breast cancer could be safely treated without using chemotherapy. At the 2024 ASCO Annual Meeting, MEDSIR presented a subanalysis of this study comparing PET scan and magnetic resonance imaging (MRI) results; both tests that participants undergo to observe the evolution of their cancer. The comparative study shows tumor assessments can be analyzed with both PET scan and MRI. Although PET scan is the recommended imaging technique for early treatment response, this exploratory study suggests that MRI could alternatively guide the treatment when PET scan are not available. MEDSIR's PATHFINDER study evaluated the safety, tolerability, and preliminary efficacy of ipatasertib in combination with non-taxane chemotherapy in patients with advanced triple negative breast cancer who had previously experienced tumor progression after treatment with taxane chemotherapy. Study results revealed that combining ipatasertib with capecitabine and eribulin has an acceptable safety profile in these patients, but that adding ipatasertib alongside carboplatin plus gemcitabine proved to be intolerable. Additionally, the combination of ipatasertib and eribulin demonstrated encouraging efficacy, warranting further investigation. TUXEDO-3, one of MEDSIR's ongoing clinical trials in Austria and Spain, is the first study evaluating the efficacy and safety of patritumab deruxtecan as an anti-cancer therapy for patients with pretreated metastatic breast cancer and advanced non-small cell lung cancer with brain metastases, and metastatic solid tumors with leptomeningeal disease. If positive, this study could streamline the introduction of HER3-DXd as a new treatment for these patients who currently have very limited therapeutic options. ABOUT UMMET CANCER NEEDS Unmet cancer needs refer to gaps in resources, support, and treatment options that exist for cancer patients. Addressing unmet cancer needs is crucial to improving quality of life and outcomes for cancer patients. Through the collaborative work of healthcare providers, policymakers, and patient advocacy groups unmet cancer needs can be identified to help provide patients with comprehensive and quality care. ABOUT MEDSIR Founded in 2012, MEDSIR works closely with its partners to drive innovation in oncology research. Based in Spain and the United States, the company manages all aspects of clinical trials, from study design to publication, utilizing a global network of experts and integrated technology to streamline the process. The company offers proof-of-concept support and a strategic approach that helps research partners experience the best of both worlds from industry-based clinical research and investigator-driven trials. To promote independent cancer research worldwide, MEDSIR has a strategic alliance with Oncoclínicas, the leading oncology group in Brazil with the greatest research potential in South America. Learn how MEDSIR brings ideas to life at . SOURCE MEDSIR

Clinical ResultASCOPhase 2Phase 3

23 May 2024

·www.prnewswire.com

Rutgers Cancer Institute and RWJBarnabas Health Set to Unveil Extensive, New Cancer Research Findings at 2024 ASCO Annual Meeting

49 scheduled presentations will explore several types of cancer, as well as the next frontier of health equity NEW BRUNSWICK, N.J., May 23, 2024 /PRNewswire/ -- Clinicians and scientists from Rutgers Cancer Institute and RWJBarnabas Health will lead sessions and present their latest discoveries from their innovative cancer research program at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held in Chicago (and online) from May 30-June 4. A total of 49 accepted abstracts and presentations will cover cutting-edge topics, including two oral sessions highlighting the National Surgical Quality Improvement Program (NSQIP) audit of enhanced recovery after surgery protocols for radical cystectomy, as well as social vulnerability and clinical trial enrollment's role in the next frontier of health equity. Continue Reading Rutgers Cancer Institute and RWJBarnabas Health "Our world-renowned integrated network of researchers and clinicians at Rutgers Cancer Institute and RWJBarnabas Health continues to innovate and investigate strategies that will achieve the best possible outcomes for our patients. This is reflected in the dynamic lineup of presentations featured at the 2024 ASCO Annual Meeting, underscoring our team's commitment and dedication," said Steven K. Libutti, MD, FACS, Director, Rutgers Cancer Institute and Senior Vice President, Oncology Services, RWJBarnabas Health. "As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center and the leading cancer program in the state, we are at the forefront of advancing cancer research and care to conquer a disease that impacts so many. We look forward to sharing our array of recent advancements and findings at this year's meeting." The research accepted for presentation at ASCO includes one late-breaking abstract, oral and poster sessions as well as publication-only abstracts highlighting data in numerous types of cancer, including breast, colorectal, lymphoma, and lung. Highlights of the accepted abstracts include the following: Findings from a study that assesses how social vulnerability impacts clinical trial enrollment and explores the interaction between race and social vulnerability among patients with one of the top five cancers - breast, prostate, lung, colorectal and pancreas. Findings confirm that neighborhood social vulnerability is a barrier to trial enrollment, even more so among Black patients. Utilization of enhanced recovery after surgery (ERAS) protocols for radical cystectomy has been associated with improved postoperative recovery and shorter hospital stays. This study was designed to assess the impact of increasing compliance to ERAS components on postoperative outcomes in patients who underwent radical cystectomy. Researchers reviewed 3,708 patients from the National Surgical Quality Improvement Program database who underwent radical cystectomy from 2019 – 2021. Updates from CTEP 10492, a Phase 1/1b study investigating the AKT inhibitor ipatasertib with chemoradiation to treat locally advanced head and neck squamous cell carcinoma (HNSCC). The primary objective of this study is to determine the maximum tolerated dose and recommended Phase 2 dose of ipatasertib in combination with definitive chemoradiation therapy (CRT) in locally advanced HNSCC based on dose-limiting toxicities. This phase 1/1b study will be the first to establish safety and preliminary efficacy of ipatasertib combined with standard of care definitive CRT for HNSCC. Data from a Phase 3 clinical trial evaluates the efficacy and safety of odronextamab plus CHOP vs rituximab plus CHOP in previously untreated diffuse large B-cell lymphoma (DLBCL) patients. OLYMPIA-3 is a Phase 3, randomized, open-label, multicenter study of O-CHOP vs. R-CHOP in patients with previously untreated DLBCL and intermediate- or high-risk features. The primary endpoints of the study are the incidence of dose-limiting toxicities, and incidence and severity of treatment-emergent adverse events as well as progression-free survival by independent central review. CIPHER (NCT05333874), a single institution pilot study, evaluated whether trend of circulating tumor DNA (ctDNA) testing during neoadjuvant therapy (NAT) can serve as an early indicator of treatment response and inform disease management in the adjuvant setting. The study included 35 patients with stage II-III triple negative and HER2+ breast cancer and longitudinal ctDNA testing performed during standard of care NAT. The full list of presentations at this year's 2024 American Society of Clinical Oncology Annual Meeting can be found here. About Rutgers Cancer Institute As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center, Rutgers Cancer Institute, together with RWJBarnabas Health, offers the most advanced cancer treatment options, including bone marrow transplantation, proton therapy, CAR T-cell therapy and complex surgical procedures. Along with clinical trials and novel therapeutics such as precision medicine and immunotherapy – many of which are not widely available – patients have access to these cutting-edge therapies at Rutgers Cancer Institute in New Brunswick, Rutgers Cancer Institute at University Hospital in Newark, as well as through RWJBarnabas Health facilities. For journalists – contact: Krista Didzbalis Corporate Communications Specialist, Strategic Communications, RWJBarnabas Health 732.507.8307 [email protected] For patient appointments/inquiries – contact: 844-CANCERNJ (844-226-2376) SOURCE Rutgers Cancer Institute and RWJBarnabas Health

Phase 3ASCOImmunotherapyClinical ResultCell Therapy

31 May 2023

·www.drugs.com

NIH’s ComboMATCH Initiative Will Test New Drug Combinations Guided by Tumor Biology

June 1, 2023 -- The National Cancer Institute (NCI) has launched a large precision medicine cancer initiative to test the effectiveness of treating adults and children with new drug combinations that target specific tumor alterations. Known as the Combination Therapy Platform Trial with Molecular Analysis for Therapy Choice (ComboMATCH), the initiative is the largest of its kind to test combinations of cancer drugs guided by tumor biology. The endeavor aims to identify promising treatments that can advance to larger, more definitive clinical trials outside of ComboMATCH. NCI is part of the National Institutes of Health. ComboMATCH comprises numerous phase 2 treatment trials that will each evaluate a drug combination—usually either two targeted drugs or a targeted drug plus a chemotherapy drug. Some trials will include patients with specific changes in their cancer cells, no matter where the cancer arose in the body, whereas others will enroll patients with specific cancer types. “The majority of treatments that patients get nowadays are not genomically determined,” said James H. Doroshow, M.D., director of NCI’s Division of Cancer Treatment and Diagnosis. “With ComboMATCH, we’re trying to show that genomic abnormalities can be used to determine the most effective treatment combinations for patients.” ComboMATCH (NCT05564377) is a cross-group collaboration among NCI and all five U.S. clinical trial groups within NCI’s National Clinical Trials Network (NCTN). ComboMATCH is a successor to NCI-MATCH, NCI’s groundbreaking precision medicine clinical trial. In NCI-MATCH, people were assigned to treatment based on genetic changes in their tumor rather than their type of cancer. For the most part, NCI-MATCH evaluated single drugs targeting the mutation thought to be driving the growth of a patient’s tumor. However, many patients quickly developed resistance to these single drugs. “With ComboMATCH, we’re hoping that by attacking both the genetic driver and the mechanisms of resistance, we will obtain more durable clinical responses and more benefit to patients,” said Jeffrey Moscow, M.D., of the Investigational Drug Branch in NCI’s Division of Cancer Treatment and Diagnosis and a co-leader of ComboMATCH. The combinations will include both U.S. Food and Drug Administration-approved drugs and investigational agents contributed by pharmaceutical companies. Hundreds of thousands of potential drug combinations exist, so one challenge has been to narrow down and prioritize the most promising ones. The overarching ComboMATCH coordination effort is led by the ECOG-ACRIN Cancer Research Group. All five U.S. NCTN groups, which include the Alliance for Clinical Trials in Oncology, Children’s Oncology Group, ECOG-ACRIN Cancer Research Group, NRG Oncology, and SWOG Cancer Research Network, will lead ComboMATCH treatment trials. “An important strength of the study is that the combinations being evaluated in ComboMATCH will be based on preclinical data showing that indeed the combination is better than either agent alone, as well as safety data from phase 1 studies,” said James Ford, M.D., of Stanford University School of Medicine, a co-leader of ComboMATCH and lead investigator on the coordination effort by ECOG-ACRIN. "There will be agreement among all the NCTN trial group representatives to evaluate each combination.” There are several ways in which patients with locally advanced or metastatic solid tumors will be identified for possible participation in ComboMATCH. In recent years, genomic testing of tumors has become a standard part of care for people with many cancer types. A doctor at any of the community hospitals and cancer centers participating in ComboMATCH can refer their patient for additional eligibility screening if the patient’s test results show that they have a particular alteration being investigated in one of the treatment trials. Any one of the nearly 35 designated commercial and academic labs that are conducting genomic testing as part of standard of care can also identify patients who might be eligible for a ComboMATCH trial. Patients who are matched to a trial will be asked to provide a pretreatment tumor biopsy specimen for genomic profiling. This will enable ComboMATCH investigators to later probe other questions, such as why some treatments worked and others didn’t. Three ComboMATCH trials are already open for enrollment: A study testing the use of fulvestrant (Faslodex) and binimetinib (Mektovi) in patients with an NF1 mutation in hormone receptor-positive breast cancer that has spread (NCT05554354) A study testing the use of selumetinib (Koselugo) and olaparib (Lynparza) or selumetinib alone in women with a RAS mutation who have endometrial or ovarian cancer that has come back or persists despite treatment (NCT05554328) A study of chemotherapy plus ipatasertib in patients with AKT mutations who have solid tumors that have spread (NCT05554380) Six additional trials will be available in the coming months, with more to be added over time. Overall, NCI plans for ComboMATCH to include about 2,000 patients, but that number could grow. Unlike MATCH, which did not include children, but rather had a separate parallel trial called PediatricMATCH, some ComboMATCH trials will include children with cancer. NCI will be launching two additional precision medicine cancer treatment trials. ImmunoMATCH has started with a pilot study to determine how prospective characterization of the immune status of a tumor can be used to improve the response to targeted treatments using immunotherapy, with plans to expand into larger studies in the future. MyeloMATCH will test treatments based on genetic changes in the cancer cells of people with acute myeloid leukemia or myelodysplastic syndromes. About the National Cancer Institute (NCI): NCI leads the National Cancer Program and NIH’s efforts to dramatically reduce the prevalence of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI website at cancer.gov or call NCI’s contact center, the Cancer Information Service, at 1-800-4-CANCER (1-800-422-6237). About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov. NIH…Turning Discovery Into Health ® Source: NIH Posted: June 2023

Phase 2Immunotherapy

100 Deals associated with Ipatasertib Dihydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Ipatasertib Dihydrochloride	-	DB11743

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Triple Negative Breast Cancer	Phase 3	US	Hoffmann-La Roche, Inc.	25 Nov 2019
Triple Negative Breast Cancer	Phase 3	JP	Hoffmann-La Roche, Inc.	25 Nov 2019
Triple Negative Breast Cancer	Phase 3	AR	Hoffmann-La Roche, Inc.	25 Nov 2019
Triple Negative Breast Cancer	Phase 3	AU	Hoffmann-La Roche, Inc.	25 Nov 2019
Triple Negative Breast Cancer	Phase 3	AT	Hoffmann-La Roche, Inc.	25 Nov 2019
Triple Negative Breast Cancer	Phase 3	BE	Hoffmann-La Roche, Inc.	25 Nov 2019
Triple Negative Breast Cancer	Phase 3	BR	Hoffmann-La Roche, Inc.	25 Nov 2019
Triple Negative Breast Cancer	Phase 3	BG	Hoffmann-La Roche, Inc.	25 Nov 2019
Triple Negative Breast Cancer	Phase 3	CA	Hoffmann-La Roche, Inc.	25 Nov 2019
Triple Negative Breast Cancer	Phase 3	CO	Hoffmann-La Roche, Inc.	25 Nov 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03498521 (CUPISCO, CTgov)	Phase 2	Neoplasms	528	platinum (Molecularly-Guided Therapy MGT) Category 1)	nwbljtavpu(xubqlzfana) = hfnywqkgdw jysjmnuoir (iejiihajvt, qfwxrtsegr - zpxsoksfnh) View more	-	14 Jun 2024
				platinum (Chemotherapy Category 1)	nwbljtavpu(xubqlzfana) = jqvderfbgk jysjmnuoir (iejiihajvt, rqduesfwth - ydhkmkezng) View more
NCT04589845 (TAPISTRY, ASCO2024)	Phase 2	Solid tumor	50	Ipatasertib 400 mg	dkyrtizrng(dzaiklhhbu) = jlwjnmghii ajldrkvirf (ttzjhgzdsa, 18.7 - 46.3) View more	Positive	24 May 2024
NCT04464174 (PATHFINDER, ASCO2024)	Phase 2	Advanced Triple-Negative Breast Carcinoma PI3K/AKT/mTOR pathway	54	Ipatasertib (IPA) + Capecitabine (CA)	azsyzhjogd(ddzaczccge) = wdjtxsxcty ysqecdwvgi (iwgotktlru ) View more	Positive	24 May 2024
				Ipatasertib (IPA) + Eribulin (E)	azsyzhjogd(ddzaczccge) = ocvelgmoob ysqecdwvgi (iwgotktlru ) View more
NCT04177108 (CTgov)	Phase 3	Triple Negative Breast Cancer	242	Paclitaxel+Atezolizumab+Ipatasertib (Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel)	rszyeibanq(dhbqpzqswg) = lzwucafykg qpfyjlawvo (vmyzircogx, drtsantnhf - onduuadayx) View more	-	27 Mar 2024
				Paclitaxel+Atezolizumab+Ipatasertib (Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxel)	rszyeibanq(dhbqpzqswg) = bkigsyajxt qpfyjlawvo (vmyzircogx, nbfcylvqnb - kcxqskfkoh) View more
NCT03337724 (IPATunity130, CTgov)	Phase 3	Breast Cancer \| Hormone receptor positive HER2 negative breast cancer	579	Placebo+Paclitaxel (Cohort A: Placebo + Paclitaxel)	kstitlyrxx(uxivbvbjmt) = bepscqutkf abshhwinej (ssjoqulknl, aammsdqkdj - ygthpucauh) View more	-	12 Mar 2024
				Paclitaxel+Ipatasertib (Cohort A: Ipatasertib + Paclitaxel)	kstitlyrxx(uxivbvbjmt) = ymusxfqjmn abshhwinej (ssjoqulknl, iuuaeunzne - kpdbvpvlde) View more
NCT03800836 (CO40151, IPATunity130, IPATunity170, Pubmed)	Phase 1	Metastatic Triple-Negative Breast Carcinoma First line NF1 \| CCND3 \| PIK3CA ... View more	317	Ipatasertib 400 mg/day	eqdpsgrsrz(pqzgggvqne) = Grade ≥3 adverse events were more frequent with the triplet than with doublets or single-agent paclitaxel vkphayfnbi (hdnbnuetsg )	-	09 Jan 2024
				Atezolizumab 840 mg
NCT03840200 (CTgov)	Phase 1	Breast Cancer \| Prostatic Cancer \| Ovarian Cancer	51	Rucaparib+Ipatasertib (Dose Escalation-Cohort 1)	silulrakrc(tqqsbjshuo) = cnglrlzulr nipnsanxlp (eaoinhtsix, nixhwquyoh - ryyjnhpxdt) View more	-	30 Oct 2023
				Rucaparib+Ipatasertib (Dose Escalation-Cohort 2a)	silulrakrc(tqqsbjshuo) = upczudcsxg nipnsanxlp (eaoinhtsix, mrucuurrlt - uqbsvnxocq) View more
NCT01485861 (A.MARTIN \| A. MARTIN \| GO27983, CTgov)	Phase 1/2	Prostatic Cancer \| Castration-Resistant Prostatic Cancer	298	Prednisone+Abiraterone+Prednisolone+Ipatasertib (Phase II: Ipatasertib 400 mg + Abiraterone)	xezuaihadk(trbvbbozdb) = mutspojfol ebnkqkaqyo (jmovxlowpz, vchbrelrku - svplpumyue) View more	-	14 Sep 2023
				Prednisone+Abiraterone+Prednisolone+Ipatasertib (Phase II: Ipatasertib 200 mg + Abiraterone)	xezuaihadk(trbvbbozdb) = hblunldjsy ebnkqkaqyo (jmovxlowpz, hrmpavwlwj - hgrilzrsqa) View more
NCT03673787 (AACR2023) Manual	Phase 1/2	Glioblastoma Second line PTEN No Expression	19	Ipatasertib+Atezolizumab	retudpvshy(sulgyvsiwe) = sbfbcvapmn chxlbcmtgm (oxbaumjxod ) View more	Positive	14 Apr 2023
				Ipatasertib+Atezolizumab (pts with PTEN loss)	retudpvshy(sulgyvsiwe) = ltlfdvparc chxlbcmtgm (oxbaumjxod )
NCT03072238 (IPATential150, CTgov)	Phase 3	Castration-Resistant Prostatic Cancer \| Prostatic cancer metastatic	1,101	Placebo+Prednisone/Prednisolone+Abiraterone (Placebo + Abiraterone)	fzfgrtdklj(uqlsmpywco) = eimcoqszcz tewlpmkhov (lhegmuaovn, nuqyshleyl - ptkevcujid) View more	-	10 Apr 2023
				Prednisone/Prednisolone+Abiraterone+Ipatasertib (Ipatasertib + Abiraterone)	fzfgrtdklj(uqlsmpywco) = mvhjncgasj tewlpmkhov (lhegmuaovn, otyhryklgo - ucsignzxmr) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis