A Phase 1b Open-Label Study to Evaluate the Safety and Tolerability of Eganelisib as Monotherapy and in Combination With Cytarabine in Patients With Relapsed/Refractory Acute Myeloid Leukemia

This is a Phase 1b open-label, multicenter, dose-escalation and dose-optimization study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of eganelisib as monotherapy and in combination with cytarabine in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or r/r higher-risk myelodysplastic syndromes (HR-MDS).
The study consists of 2 parts:
* Part 1: Dose Escalation (DE) in both monotherapy and in combination.
* Part 2: Dose Optimization

Start Date15 Jan 2025

Sponsor / Collaborator

Stelexis Therapeutics LLCStartup

NCT03795610 / RecruitingPhase 2IIT

Phase 2 Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma

The purpose of this study is to investigate how effective the study drug IPI-549 is against types of cancers. IPI-549 is considered experimental because it is not approved by the US Food and Drug Administration (FDA) for the treatment of cancer.
Patients will be treated with 2 weeks of IPI-549, a specific PI3Kγ inhibitor. Tumor tissue for research purposes through core biopsies will be obtained prior to initiation of IPI-549 and at surgery.

Start Date06 Mar 2020

Sponsor / Collaborator

University of California San Diego

[+1]

NCT03961698 / Active, not recruitingPhase 2

Ph 2, Multi-arm, Multicenter, Open-label Study to Evaluate Efficacy and Safety of IPI-549 Administered in Combo With Front-line Treatment Regimens in Pts With Locally Advanced and/or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma

MARIO-3 is a Phase 2 multi-arm combination cohort study designed to evaluate IPI-549, Infinity Pharmaceutical's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase (PI3K)-gamma, in combinations with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq and Avastin (bevacizumab) in front-line renal cell cancer (RCC).

Start Date17 Dec 2019

Sponsor / Collaborator

Infinity Pharmaceuticals, Inc.

[+1]

100 Clinical Results associated with Eganelisib

100 Translational Medicine associated with Eganelisib

100 Patents (Medical) associated with Eganelisib

Literatures (Medical) associated with Eganelisib

01 Dec 2024·International Journal of Biological Macromolecules

STING agonists and PI3Kγ inhibitor co-loaded ferric ion-punicalagin networks for comprehensive cancer therapy

Article

Author: Sheng, Ren ; Han, Qing ; Peng, Xueqiang ; Zheng, Shaoqin ; Li, Zhuang ; Liu, Siyu ; Guo, Yitong

Nanoparticles-based drug delivery system has been a promising approach for the treatment of colorectal cancer (CRC), which can be combined with chemotherapy, targeted therapy and immunotherapy to improve the treatment of CRC. 2'3' cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) is an agonist of the STING signaling pathway activating antitumor immunity. IPI-549 is a small-molecule inhibitor for phosphatidylinositol 3-kinase γ (PI3Kγ), which can induce M1 macrophages polarization to provide pro-inflammatory microenvironment to suppress tumors. Here, we developed a ferric ion-punicalagin network (Fe-PU), which can be not only used as an inducer of ferroptosis, but also serve as a carrier to load cGAMP and IPI-549 to obtain nanohybrid (Fe-PU/CD-IPI). In order to improve the delivery effect and targeted ability to CRC, a cyclic arginine-glycine-aspartic acid peptide linked-bovine serum albumin were utilized to modify Fe-PU/CD-IPI to prepare nanohybrid Fe-PU/CD-IPI@cBSA. The therapeutic effect of various nanohybrids were validated in the mice with spontaneous tumor in the colorectal area and tumor-bearing mice, which lead to the increase of ferroptosis, the activation of STING signaling pathway, and the repolarization of macrophages. Collectively, the cGAMP and IPI-549 co-loaded nanohybrids effectively reshaped the tumor immune microenvironment, and exhibited prominent treatment effect of anti-colorectal cancer in vitro, patient-derived organoids, and in vivo.

01 Aug 2024·International Journal for Parasitology: Drugs and Drug Resistance

Oral administration of IPI549 protects mice from neuropathology and an overwhelming inflammatory response during experimental cerebral malaria

Article

Author: Peng, Chuanyang ; Zhao, Yan ; Pang, Wei ; Yao, Shijie ; Min, Hui ; Bian, Zhifang ; Jin, Zhuoru ; Zheng, Li ; Cao, Yaming ; Wen, Yixin

Infection with Plasmodium falciparum is often deadly when it results in cerebral malaria, which is associated with neuropathology described as an overwhelming inflammatory response and mechanical obstruction of cerebral microvascular. PI3Kγ is a critical component of intracellular signal transduction and plays a central role in regulating cell chemotaxis, migration, and activation. The purpose of this study was to examine the relationship between inhibiting the PI3Kγ pathway and the outcome of experimental cerebral malaria (ECM) in C57BL/6J mice infected with the mouse malaria parasite, Plasmodium berghei ANKA. We observed that oral administration of the PI3Kγ inhibitor IPI549 after infection completely protected mice from ECM. IPI549 treatment significantly dampened the magnitude of inflammatory responses, with reduced production of pro-inflammatory factors, decreased T cell activation, and altered differentiation of antigen-presenting cells. IPI549 treatment protected the infected mice from neuropathology, as assessed by an observed reduction of pathogenic T cells in the brain. Treating the infected mice with IPI549 three days after parasite inoculation improved the murine blood brain barrier (BBB) integrity and helped the mice pass the onset of ECM. Together, these data indicate that oral administration of the PI3Kγ inhibitor IPI549 has a suppressive role in host inflammation and alleviates cerebral pathology, which supports IPI549 as a new malaria treatment option with potential therapeutic implications for cerebral malaria.

01 Aug 2024·Journal for ImmunoTherapy of Cancer

Eganelisib combined with immune checkpoint inhibitor therapy and chemotherapy in frontline metastatic triple-negative breast cancer triggers macrophage reprogramming, immune activation and extracellular matrix reorganization in the tumor microenvironment

Article

Author: Juric, Dejan ; Hamilton, Erika ; Soliman, Hatem ; O'Connell, Brenda C ; Cobleigh, Melody A ; Hubbard, Charley ; Ilaria, Robert ; Peluso, Stephane ; Fitzgerald, Donna ; Kutok, Jeffrey L ; Tkaczuk, Kate H R ; Elias, Anthony ; Dakhil, Shaker ; Varner, Judith ; Lee, Arielle ; Zizlsperger, Nora

BackgroundTriple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer with a poor prognosis particularly in the metastatic setting. Treatments with anti-programmed cell death protein-1/programmed death-ligand 1 (PD-L1) immune checkpoint inhibitors (ICI) in combination with chemotherapies have demonstrated promising clinical benefit in metastatic TNBC (mTNBC) but there is still an unmet need, particularly for patients with PD-L1 negative tumors. Mechanisms of resistance to ICIs in mTNBC include the presence of immunosuppressive tumor-associated macrophages (TAMs) in the tumor microenvironment (TME). Eganelisib is a potent and selective, small molecule PI3K-γ inhibitor that was shown in preclinical studies to reshape the TME by reducing myeloid cell recruitment to tumors and reprogramming TAMs from an immune-suppressive to an immune-activating phenotype and enhancing activity of ICIs. These studies provided rationale for the clinical evaluation of eganelisib in combination with the anti-PD-L1 atezolizumab and nab-paclitaxel in firstline mTNBC in the phase 2 clinical trial MAcrophage Reprogramming in Immuno-Oncology-3 (MARIO-3,NCT03961698). We present here for the first time, in-depth translational analyses from the MARIO-3 study and supplemental data from eganelisib monotherapy Ph1/b study in solid tumors (MARIO-1,NCT02637531).MethodsPaired pre-treatment and post-treatment tumor biopsies were analyzed for immunophenotyping by multiplex immunofluorescence (n=11), spatial transcriptomics using GeoMx digital spatial profiling (n=12), and PD-L1 immunohistochemistry, (n=18). Peripheral blood samples were analyzed using flow cytometry and multiplex cytokine analysis.ResultsResults from paired tumor biopsies from MARIO-3 revealed gene signatures of TAM reprogramming, immune activation and extracellular matrix (ECM) reorganization. Analysis of PD-L1 negative tumors revealed elevated ECM gene signatures at baseline that decreased after treatment. Gene signatures of immune activation were observed regardless of baseline PD-L1 status and occurred in patients having longer progression-free survival. Peripheral blood analyses revealed systemic immune activation.ConclusionsThis is the first report of translational analyses including paired tumor biopsies from a phase 2 clinical study of the first-in-class PI3K-γ inhibitor eganelisib in combination with atezolizumab and nab-paclitaxel in frontline mTNBC. These results support the mechanism of action of eganelisib as a TAM-reprogramming immunotherapy and support the rationale for combining eganelisib with ICI and chemotherapy in indications with TAM-driven resistance to ICI.

News (Medical) associated with Eganelisib

01 Aug 2024

·www.globenewswire.com

Context Therapeutics Appoints Chief Medical Officer and Vice President of Clinical Operations

Company announces appointments of Dr. Claudio Dansky Ullmann as CMO and Ms. Karen Andreas as VP, Clinical Operations Appointments support the development of the Company’s two clinical-stage T cell engaging assets to treat solid tumors PHILADELPHIA, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced the appointment of Claudio Dansky Ullmann, M.D. as Chief Medical Officer (“CMO”) and Karen Andreas, M.S. as Vice President, Clinical Operations. “We are thrilled to welcome Dr. Dansky Ullmann and Ms. Andreas to our team at this exciting time as the Company advances its product candidates, CTIM-76 and CT-95, into Phase 1 clinical trials,” said Martin Lehr, CEO of Context. “Dr. Dansky Ullmann and Ms. Andreas are industry veterans with deep expertise in oncology and T cell therapies, and a proven track record of advancing programs through clinical development.” Dr. Dansky Ullmann brings over 30 years of experience in early and late-stage oncology therapeutics development. Most recently, he was the CMO at Avenge Bio, where Dr. Dansky Ullmann guided the clinical advancement of AVB-001 allogeneic cell therapy for ovarian cancer. Prior to Avenge, Dr. Dansky Ullmann was CMO at MaxCyte where he was responsible for the development of the CARMA™ chimeric antigen receptor (CAR) therapy program, including MCY-M11, a mesothelin-targeting CAR therapy. Previously, he was the Senior Vice President, Head of Clinical Development at Infinity Pharmaceuticals, where he led the development of Copiktra® through FDA approval and eganelisib through first in human studies. Earlier, he was Global Clinical Lead in the Oncology Therapy Area Unit at Takeda Pharmaceuticals. Before, Dr. Dansky Ullmann was a Senior Investigator in the Cancer Therapy Evaluation Program at the National Cancer Institute, where he was involved in the strategic development of novel agents through Phase 1-3 clinical trials. Dr. Dansky Ullmann earned his M.D. at the School of Medicine, Universidad de Buenos Aires and completed his medical oncology training at Guemes Private Hospital, Buenos Aires. “I am excited to join the leadership team at Context, which is focused on building an innovative portfolio of clinical stage T cell engaging bispecific therapeutics,” said Dr. Dansky Ullmann. “I look forward to contributing to the team to help bring potential best-in-class and first-in-class treatments to patients in need.” Ms. Andreas’ biopharma career spans almost 20 years in multiple cross-functional roles across the drug development process, maintaining a primary focus in oncology at small to midsize companies. Prior to joining Context, Ms. Andreas was Vice President, Clinical Operations at Avenge Bio where she was responsible for oversight of all clinical trial activities, clinical operations strategy, planning, and execution for a first in human allogeneic cell therapy for ovarian cancer. Previously, at Boston Pharmaceuticals, Ms. Andreas led clinical operations and program management for zeteletinib through proof of concept and other oncology assets through early development. Ms. Andreas also spent 10 years with Merrimack Pharmaceuticals in various roles advancing multiple oncology and immunology-focused assets and three years at ArQule advancing the company's first early-stage studies. Ms. Andreas holds a bachelor’s degree in biology from Colby College and a Master of Science from Tufts University School of Medicine. Ms. Andreas stated, “I look forward to working with the entire Context team and utilizing my clinical operations background to support the advancement of the Company’s two clinical stage assets, CTIM-76 and CT-95.” Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) In connection with the employment of Dr. Dansky Ullmann, the Company will grant a non-qualified stock option award in an amount of 202,170 shares of the Company's common stock as an inducement material to him accepting employment with the Company. Such stock option will have an exercise price equal to the closing price of the Company’s common stock as reported by Nasdaq as of the close of market on August 1, 2024, which will be the date of grant. The Company also hired an additional employee on August 1, 2024 and anticipates two additional hires starting on August 12, 2024. These employees will be granted non-qualified stock option awards in an aggregate amount of 115,237 shares of the Company's common stock as an inducement material to each of them accepting employment with the Company, with an exercise price equal to the closing price of the Company’s common stock as reported on Nasdaq as of the close of market on the date of commencement of such employee’s employment. All such stock options will vest as to 25% of the shares on the first anniversary of the date of grant and in successive equal monthly installments over the subsequent three years, subject to continued employment with the Company and the terms and conditions in the stock option agreement. All such stock options are respectively granted as an inducement award pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. About Context Therapeutics®Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing medicines for solid tumors that is building an innovative portfolio of clinical-stage T cell engaging bispecific therapeutics. Product candidates include CTIM-76, a Claudin 6 x CD3 bispecific antibody, and CT-95, a mesothelin x CD3 bispecific antibody. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on X (formerly Twitter) and LinkedIn. Forward-looking StatementsThis press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the ability of the new appointments to support the Company and the advancement of its product candidates; (ii) the potential benefits, characteristics, safety and side effect profile of our product candidates, (iii) the ability of our product candidates to have benefits, characteristics, manufacturability, and a side effect profile that is differentiated and/or better than third party product candidates, (iv) the likelihood data will support future development of our product candidates, and (v) the likelihood of obtaining regulatory approval for our product candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we therefore cannot assure you that our plans, intentions, expectations, or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise. Investor Relations Contact:Jennifer Minai-AzaryContext TherapeuticsIR@contexttherapeutics.com

Cell TherapyPhase 1Executive ChangeImmunotherapy

09 Jul 2024

·www.fiercebiotech.com

Cancer drug from lab of bankrupt biotech works against COVID-19 and MRSA lung damage in mice

Before Infinity Pharmaceuticals shut down, eganelisib was fast-tracked by the FDA for potential use in triple-negative breast cancer in combination with other drugs. Just in time for a summer COVID wave to remind us that SARS-CoV-2 is here to stay, researchers at the University of California, San Diego (UCSD) have published new findings that show an experimental cancer drug developed by a now-bankrupt biotech can suppress the virus in lung tissue. In a July 3 article in Science Translational Medicine, the UCSD team established that levels of damage-causing immune cells called myeloid cells are raised in the lungs of people with COVID-19 and other infections, like methicillin-resistant staphylococcus aureus (MRSA). Targeting an enzyme called phosphatidylinositol 3,4,5-kinase gamma (PI3Kγ) with the small molecule inhibitor eganelisib—a clinical-stage anti-cancer agent developed by Infinity Pharmaceuticals, which declared Chapter 11 bankruptcy in October 2023—reduced the number of myeloid cells in the lungs and improved the survival rate of mice infected with either COVID-19 or MRSA. “Other drugs were tested early during the COVID-19 crisis for similar effects, with only modest success,” Judith Varner, Ph.D., the paper’s senior author who also studied eganelisib on behalf of Infinity, said in a press release. “Our work is significant because this is the first time this particular approach of targeting the myeloid cells specifically has been shown to be effective in COVID.” Myeloid cells release immune pathway signaling proteins called cytokines and are thus an essential part of the immune system. But the inflammation they cause can go awry and lead to life-threatening lung damage, as happens in some patients with COVID-19 as well as those who are co-infected with flu and MRSA. PI3Kγ is a key component of this process because it helps myeloid cells move into virus-infected organs. It does the same thing in cancerous tissues, which was the logic behind eganelisib’s mechanism of action. Stopping PI3Kγ’s activity stops myeloid cell migration, ameliorating tissue damage. Before Infinity shut down, eganelisib was fast-tracked by the FDA for potential use in triple-negative breast cancer in combination with other drugs. A phase 1 study on that indication was completed in May 2024. Clinical trials for its use in urethral cancer, head and neck cancer and renal cell carcinoma were also underway. Now, the team behind the research hopes that it will lead drug companies to develop compounds similar to eganelisib to treat COVID-19, MRSA and other diseases that cause myeloid-cell-driven organ damage. Varner also said in the release that she hopes the latest findings will lead to more funding for her team to continue their work in a range of disease settings. Fierce has reached out to UCSD for comment.

Phase 1

08 Jul 2024

·www.drugs.com

Could a Cancer Drug Curb the Organ Damage of Severe COVID?

MONDAY, July 8, 2024 -- An experimental cancer drug might be able to help prevent the organ damage caused by severe COVID infections, a new study finds. The drug, called eganelisib, inhibits an immune system enzyme called PI3K gamma that boosts damaging inflammation in cancerous tumors. But lab studies in mice and human tissue showed that eganelisib could also be effective in suppressing organ-damaging inflammation caused by COVID, according to findings published July 3 in the journal Science Translational Medicine . COVID is mainly known as a lung disease, but severe cases are known to damage the heart, gastrointestinal system, kidneys, brain and nervous system. This damage contributes to Long COVID -- a debiltating condition where symptoms that last months and years beyond the initial infection. The P13K gamma enzyme causes a type of white blood cell called myeloid cells to flood tumor tissue, creating inflammation that worsens cancer, researchers said. Myeloid cells are meant to work quickly to kill potentially deadly bacteria and viruses, including the coronavirus behind COVID, researchers said. Unfortunately, they can do a lot of damage if the immune system overreacts to a severe infection, said senior researcher Judith Varner , a professor of pathology and medicine at the University of California, San Diego (UCSD). “If you have a little infection, myeloid cells come in, kill bacteria, release alerts that recruit even more potent killer immune cells, and produce substances that can heal the damage,” Varner explained in a UCSD news release. “But if you get an infection that's too strong, you get overproduction of these alert signals and the substances they release to kill these infective agents can also kill yourself,” Varner added. “That's what happens in COVID-19.” In lab tests, researchers found that eganelisib can keep myeloid cells from doing damage to human tissue and infected lab mice. “We sequenced COVID-19 patient lung tissue and showed that when patients have COVID-19, a lot of their lung cells are killed and there's a huge increase in myeloid cells,” Varner said. “We also found the same thing in infected mice.” “When we treated with the drug, we showed that eganelisib prevents entry of myeloid cells into tissue so they can’t do all that damage,” Varner added. “Further studies will determine if it can actually reverse damage.” Eganelisib had similar results in mice infected with MRSA, researchers said. Most approved COVID drugs target the virus, either by preventing infection or inhibiting the virus’ spread, researchers said. Eganelisib works by targeting the person’s immune system, preventing a damaging overreaction that causes tissue scarring. No other drug with a similar approach to treating COVID has been approved yet. Eganelisib received fast-track designation from the U.S. Food and Drug Administration in 2020, but has not yet been approved. The company that developed the drug, Infinity Pharmaceuticals, declared bankruptcy in 2023. Varner said she hopes these results will lead drugmakers to develop other PI3K gamma inhibitors to treat infectious diseases like COVID and MRSA. “We hope that this research will help us obtain funding to continue investigating this approach in other disease settings,” Varner added. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Fast Track

100 Deals associated with Eganelisib

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Urothelial Carcinoma	Phase 2	IT	Infinity Pharmaceuticals, Inc.	25 Sep 2019
Advanced Urothelial Carcinoma	Phase 2	ES	Infinity Pharmaceuticals, Inc.	25 Sep 2019
Advanced Urothelial Carcinoma	Phase 2	FR	Infinity Pharmaceuticals, Inc.	25 Sep 2019
Advanced Urothelial Carcinoma	Phase 2	US	Infinity Pharmaceuticals, Inc.	25 Sep 2019
Advanced Urothelial Carcinoma	Phase 2	PL	Infinity Pharmaceuticals, Inc.	25 Sep 2019
Advanced Urothelial Carcinoma	Phase 2	RS	Infinity Pharmaceuticals, Inc.	25 Sep 2019
Advanced Urothelial Carcinoma	Phase 2	CZ	Infinity Pharmaceuticals, Inc.	25 Sep 2019
Bladder Cancer	Phase 2	IT	Infinity Pharmaceuticals, Inc.	25 Sep 2019
Bladder Cancer	Phase 2	RS	Infinity Pharmaceuticals, Inc.	25 Sep 2019
Ovarian Cancer	Phase 2	-	Infinity AS	-

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03961698 (MARIO-3, Corporate Publications) Manual	Phase 2	Triple Negative Breast Cancer \| Transitional Cell Carcinoma First line Triple Negative	49	Atezolizumab+Albumin-Bound Paclitaxel+Eganelisib	(emqegxbuxe) = kuradnvsza fegtmqpuyu (jjghitfsju ) View more	Positive	27 Jul 2021
NCT03980041 (MARIO-275, ASCO_GU2021) Manual	Phase 2	Advanced Urothelial Carcinoma	-	nivolumab+IPI 549	(nnmlnljnnk) = efyjrmolye kcvbflxvhv (fnwywcauhh ) View more	Positive	20 Feb 2021
NCT03980041 (MARIO-275, ASCO_GU2021) Manual	Phase 2	Advanced Urothelial Carcinoma	-	placebo+nivolumab	(nnmlnljnnk) = xkzwhpoawl kcvbflxvhv (fnwywcauhh, 1 - 91) View more	Positive	20 Feb 2021
NCT03719326 (ARC-2, AACR2021) Manual	Phase 1	Ovarian Cancer \| Metastatic Triple-Negative Breast Carcinoma	29	AB928 150 mg + pegylated liposomal doxorubicin (Doublet)	(xcvazndhby) = Four pts reported 6 Gr ≥3 SAEs kvlnjquotl (wrgjesaqad ) View more	Positive	15 Feb 2021
NCT03719326 (ARC-2, AACR2021) Manual	Phase 1		29	IPI-549 40 mg + AB928 150 mg + pegylated liposomal doxorubicin (Triplet)		Positive	15 Feb 2021
NCT02637531 (IPI-549-01, SITC2020)	Phase 1	Melanoma	180	Eganelisib 40 mg	ccypjkfbmn(nlkeahebcs) = 22.8% of patients treated with eganelisib + nivolumab experienced anemia pqeqbhskej (npkxwrcrtx ) View more	Positive	09 Nov 2020
NCT02637531 (IPI-549-01, SITC2018)	Phase 1	Advanced Malignant Solid Neoplasm	57	IPI-549 40 mg QD PO + nivolumab 240 mg Q2W IV	oceqlynrih(cqmysotitu) = btpljmpdws fsdmcgacmm (woxinclqge ) View more	Positive	01 Dec 2018
NCT02637531 (MARIO-1, Corporate Publications) Manual	Phase 1	Solid tumor	82	Opdivo+IPI-549	(clqrynfaha) = aqhcknniro bdmvjrrqra (uvbontykjw ) View more	Positive	10 Nov 2018
NCT02637531 (ASCO2018) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	31	Nivolumab+IPI-549 (dose-escalation)	(aihkftbkbr) = 2 DLTs each occurred at IPI-549 30 mg (Gr 3 rash) and 40 mg QD (Gr 3 rash; Gr 3 ALT/AST increase) wsktklemxg (ufafmhruxg ) View more	Positive	04 Jun 2018
NCT02637531 (Phase 1/1b study, SITC2017)	Phase 1	Advanced Malignant Solid Neoplasm	19	IPI-549 10 mg qd	qbepoaywny(vytymdbvse) = The most common (â¥2 patients) drug related treatment-emergent adverse events are alanine aminotransferase increase, rash maculo-papular, white blood cell count decrease, and headache nzfdbwoewl (wczyfxkhzr ) View more	Positive	07 Dec 2017
NCT02637531 (Phase 1/1b study, SITC2017)	Phase 1	Advanced Malignant Solid Neoplasm	19	IPI-549 15 mg qd		Positive	07 Dec 2017

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