HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn:
* About the safety and how well people tolerate of patritumab deruxtecan
* How many people have the cancer respond (get smaller or go away) to treatment

Start Date26 Feb 2025

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

[+1]

NCT06439693

/ Not yet recruitingPhase 2IIT

A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study:

The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1), followed by Trastuzumab plus Pertuzumab plus Tucatinib) in HER2+ Breast Cancer. The study will help investigators understand whether first intensifying therapy for a specific period and then stopping treatment is safe and effective for participants.
The names of the study drugs involved in this study are:
Paclitaxel (a type of anti-microtubule agent)
Docetaxel (a type of anti-microtubule agent)
Nab-Paclitaxel (a type of anti-microtubule agent)
Trastuzumab (a type of IgG1 kappa monoclonal antibody)
Pertuzumab (a type of monoclonal antibody)
Trastuzumab Deruxtecan (a type of HER2-directed antibody drug conjugate)
Tucatinib (Tyrosine Kinase HER2 Inhibitor)
Ado-trastuzumab emtansine or T-DM1 (a type of HER2-targeted antibody-drug conjugate)

Start Date01 Nov 2024

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06157892

/ RecruitingPhase 1/2

A Phase 1b/2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination With Other Anticancer Therapies in Solid Tumors

This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. This is called advanced or metastatic cancer.
Participants in this study must have breast cancer or gastric cancer. Participants must have tumors that have HER2 on them. This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumors that express HER2.
This clinical trial uses an experimental drug called disitamab vedotin (DV). Disitamab vedotin is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them.
This clinical trial uses a drug called tucatinib, which has been approved to treat cancer in the United States and some other countries. This drug is sold under the brand name TUKYSA®.
This study will test how safe and how well DV, with or without tucatinib, is for participants with solid tumors. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.

Start Date20 May 2024

Sponsor / Collaborator

Seagen Inc.

[+1]

100 Clinical Results associated with Tucatinib

100 Translational Medicine associated with Tucatinib

100 Patents (Medical) associated with Tucatinib

320

Literatures (Medical) associated with Tucatinib

01 Dec 2025·Current Neurology and Neuroscience Reports

Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review

Review

Author: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek

PURPOSE OF REVIEW:

Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.

RECENT FINDINGS:

In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.

26 Jan 2025·Future Oncology

MOUNTAINEER-03 phase III study design: first-line mFOLFOX6 + tucatinib + trastuzumab for HER2+ metastatic colorectal cancer

Article

Author: Cercek, Andrea ; Ramos, Jorge ; Heinemann, Volker ; Yoshino, Takayuki ; Nakamura, Yoshiaki ; Guan, Xuesong ; Raghav, Kanwal ; Bekaii-Saab, Tanios ; Tabernero, Josep ; Siena, Salvatore ; Van Cutsem, Eric ; Strickler, John H ; Andre, Thierry

Patients diagnosed with metastatic colorectal cancer (mCRC) have a poor prognosis with survival ranging 2-3 years. The prevalence of human epidermal growth factor receptor 2 (HER2) amplification is approximately 3-4% in mCRC and increases up to 8% in patients with KRAS/NRAS/BRAF wild-type (WT) CRC tumors. Tucatinib is a highly selective HER2-directed tyrosine kinase inhibitor that, in combination with trastuzumab, has demonstrated clinically meaningful activity in patients with chemotherapy-refractory, HER2-positive (HER2+), RAS WT mCRC in the MOUNTAINEER trial. The MOUNTAINEER-03 phase III trial is designed to investigate the efficacy and safety of first-line tucatinib in combination with trastuzumab and modified FOLFOX6 (mFOLFOX6) versus standard of care (mFOLFOX6 plus bevacizumab or cetuximab) in patients with untreated HER2+, RAS WT locally advanced unresectable or mCRC. MOUNTAINEER-03 will include two arms of approximately 400 patients randomized 1:1 to either treatment arm. The primary endpoint is progression-free survival per RECIST v1.1 by blinded independent central review (BICR). Key secondary endpoints are overall survival and confirmed objective response rate (according to RECIST v1.1 per BICR). Safety assessments will include surveillance and recording of adverse events, physical examination findings, vital signs, cardiac assessments, Eastern Cooperative Oncology Group performance status, concomitant medications, and laboratory tests.Clinical trial registration: NCT05253651 (ClinicalTrials.gov).

01 Jan 2025·ESMO Open

Results of a patient-level pooled analysis of three studies of trastuzumab deruxtecan in HER2-positive breast cancer with active brain metastasis

Article

Author: Gion, M ; Llombart-Cussac, A ; Cortés, J ; Braga, S ; Hughes, M ; Pereslete, A ; Anders, C ; Preusser, M ; Sammons, S ; Van Swearingen, A E D ; Kabraji, S ; Pinto, P B C ; Lin, N U ; Starzer, A M ; Berghoff, A S ; Furtner, J ; Murthy, R K ; Pérez-García, J M ; Bartsch, R ; Vaz Batista, M ; Sampayo-Cordero, M ; Marhold, M

BACKGROUND:

Brain metastases (BMs) are common in human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer, increasing morbidity and mortality. Systemic therapy for BMs can be effective, with the triple combination of trastuzumab, capecitabine, and tucatinib being a potential standard. More recently, intracranial activity of antibody-drug conjugates has been reported, but the size of individual studies has been small. Therefore, this patient-level pooled analysis was conducted.

PATIENTS AND METHODS:

This is a patient-level pooled analysis of the prospective phase II DEBBRAH and TUXEDO-1 trials and the retrospective DFCI/Duke/MDACC cohort. Patients with evaluable active BMs (defined as newly diagnosed and untreated or progressing with measurable tumor-related size after previous local therapy) from HER2-positive breast cancer (BC) and treated with trastuzumab deruxtecan (T-DXd) included in these studies were eligible. The primary endpoint was intracranial objective response rate (ORR-IC) by Response Assessment in Neuro-Oncology (RANO)-BM criteria.

RESULTS:

Overall, 37 patients were assessable for intracranial response assessment. BMs progressing after prior local therapy were present in 64.9% of patients. The median patient age was 49.1 years. All patients had received prior trastuzumab and the median number of prior systemic treatment lines was 3 (0-13). The pooled ORR-IC by RANO-BM criteria was 64.9% [95% confidence interval (CI) 47.5% to 79.8%] with low heterogeneity observed between the studies included. The clinical benefit rate by RANO-BM was 81.1% (95% CI 64.8% to 92.0%). The median progression-free survival was 13.3 months (95% CI 8.4-22.6 months) and the median overall survival was 22.5 months (95% CI 14.9 months-not achieved) with high heterogeneity between studies and numerically longer in patients with few prior treatment lines. Quality of life remained stable throughout treatment, with no new safety concerns.

CONCLUSIONS:

This patient-level pooled analysis of DEBBRAH, TUXEDO-1, and the DFCI/Duke/MDACC cohort indicates clinically relevant intracranial activity of T-DXd in patients with active HER2-positive BC, BMs, and extensive systemic pretreatment. The results therefore support the use of T-DXd when clinically indicated irrespective of BMs.

105

News (Medical) associated with Tucatinib

09 Jan 2025

·www.businesswire.com

Biocom California Appoints New Members to its Board of Directors

SOUTH SAN FRANCISCO, Calif. & LOS ANGELES & SAN DIEGO--( BUSINESS WIRE )--Biocom California, the association representing the California life science industry, today announced that it appointed Aliza Apple, Ph.D., a vice president of Catalyze360 AI/ML at Eli Lilly; Carolyn Ng, Ph.D., business unit partner at TPG Life Sciences Innovations; and Nancy Whiting, Pharm.D., president and CEO at Recludix Pharma, to its board of directors. Additionally, Tim Scott has assumed his role as CEO and president of Biocom California, and Sabrina Martucci Johnson, CEO at Daré Biosciences, has been appointed board chair. “Our new members’ expertise in drug discovery, clinical development and navigating the fundraising environment will complement the diverse perspectives of our current board,” said Tim Scott, president and CEO of Biocom California. “As the life science industry evolves, we continue to rely on the deep industry knowledge and key insights of our board of directors, helping shape our 2025 initiatives and ensure we meet the needs of our member companies and foster innovative progress throughout California.” Aliza Apple, Ph.D. is a vice president of Catalyze360 AI/ML at Eli Lilly. In this capacity, Dr. Apple leads the strategy, build and launch of Lilly’s external-facing AI/ML efforts for drug discovery. In her previous role at Lilly, Dr. Apple served as the COO and head of Lilly Gateway Labs West Coast, where she supported the local biotech ecosystem through early engagement and providing tailored offerings to meet their needs. Prior to Lilly, Dr. Apple served as a co-founder at Santa Ana Bio, a venture-backed precision biologics company focused on autoimmune disease, and as an advisor to the founders of Firefly Biologics. Prior to biotech, Dr. Apple was a partner in McKinsey & Co’s life sciences practice. During her nine years at McKinsey in New York and San Francisco, she collaborated with leaders from over 20 biopharma companies to develop their corporate and portfolio strategies, evaluate business development opportunities and improve their organizational effectiveness. Dr. Apple completed her Ph.D. in bioengineering at UC Berkeley and UCSF, and holds a bachelor of science in physics from Georgetown University. She completed a postdoctoral fellowship at Cornell Medical College supported by the NIH Kirschtein National Research Service Award. Carolyn Ng, Ph.D. is a business unit partner at TPG Life Sciences Innovations, where she is one of the founding senior leaders of the investment fund. She has spent the past decade of her career leading investments into transformative companies of early to mid-stage in different therapeutic areas. She currently serves on the board of directors of Adcendo, Mbrace Therapeutics and Bicara Therapeutics. Prior to joining TPG in 2021, Dr. Ng was a managing director at Vertex Ventures HC, a global healthcare and life sciences venture fund, where she co-headed the investment team. Dr. Ng has previously served on the board of directors for other promising public and private life sciences companies including Bicycle Therapeutics PLC, Boundless Bio, Obsidian Therapeutics, 28-7 Therapeutics, Epirium Bio, Nuvaira and a board observer to Visterra (acquired by Otsuka Pharmaceutical). Dr. Ng is a mentor to the Women in Bio Boardroom Ready Program. She also currently serves on the panel of the Singapore Therapeutics Development Review Panel, a funding scheme aimed at identifying high-value drug discovery and development projects from the public research community in Singapore. Prior to her investing career, Carolyn was a consultant at Deallus Consulting, a specialized life sciences strategy consulting firm where she collaborated with leaders of global biopharmaceutical companies. Dr. Ng holds a Ph.D. in cancer molecular biology from the National University of Singapore, where she was the recipient of the prestigious NGS, Integrative Sciences and Technology, Ph.D. scholarship, and patent holder of a novel small molecule nuclear receptor activator indicated for the treatment of neuroblastoma. Nancy Whiting, Pharm.D. is a president and CEO at Recludix Pharma. Previously, Dr. Whiting was a 15-year veteran of Seagen, formerly Seattle Genetics, and served as the executive vice president of corporate strategy, where she had the broad remit of corporate strategy and planning, strategic alliances and partnerships, investor relations, corporate communications and information technologies. During her tenure, she was also the executive vice president of late-stage development, senior vice president of clinical development and medical affairs, and head of experimental medicine. Dr. Whiting played a central role in the development and regulatory approval of ADCETRIS for lymphoma, PADCEV for bladder cancer, TUKYSA for breast cancer, TIVDAK for cervical cancer and several other pipeline compounds. Prior to transitioning to the pharmaceutical industry, Dr. Whiting practiced as a clinical oncology pharmacist at the Seattle Cancer Care Alliance. She currently serves on the board of directors of Caribou BioSciences and Boundless BioSciences. Dr. Whiting completed her undergraduate training at the University of British Columbia and received her Pharm.D. from the University of Washington. She also completed a residency in clinical pharmacy practice at Vancouver General Hospital. About Biocom California Biocom California is the leader and advocate for California’s life science sector. We work on behalf of more than 1,800 members to drive public policy , build an enviable network of industry leaders , create access to capital , introduce cutting-edge STEM education programs and create robust value-driven purchasing programs . Founded in 1995 in San Diego, Biocom California provides the strongest public voice to research institutions and companies that fuel the local and state-wide economy. Our goal is simple: to help our members produce novel solutions that improve the human condition. In addition to our San Diego headquarters , Biocom California operates core offices in Los Angeles and the San Francisco Bay Area , with satellite offices in Sacramento , Washington, D.C. and Tokyo . Our broad membership benefits apply to biotechnology, pharmaceutical, medical device, genomics and diagnostics companies of all sizes, as well as to research universities and institutes, clinical research organizations, investors and service providers. For more information on Biocom California, please visit our website at www.biocom.org . Connect with us on LinkedIn , Facebook and X .

Executive Change

13 Sep 2024

·www.fiercepharma.com

ESMO: AZ, Daiichi build case for Enhertu in breast cancer patients with brain metastases

Enhertu is one of six marketed products that AZ expects could reach more than $5 billion global sales at peak. Daiichi Sankyo and AstraZeneca are padding the case for their antibody-drug conjugate Enhertu with new data demonstrating the medicine’s worth in patients whose cancer has spread to the brain.The partners unveiled positive results from the phase 3b/4 DESTINY-Breast12 study, which saw Enhertu chart substantial overall and intracranial clinical activity in a large clutch of patients with HER2-positive metastatic breast cancer who have brain metastases and received two or less lines of therapy in the metastatic setting.The data on the antibody-drug conjugate (ADC) were simultaneously published in Nature Medicine and presented as a late-breaking presentation at the 2024 meeting of the European Society for Medical Oncology (ESMO) Friday.The results won’t drive a new indication for Enhertu given that the drug’s current label doesn’t exclude patients with brain metastases. But data on those particular patients, which was previously limited, now add to a growing body of evidence around Enhertu’s merit. On the trial’s primary progression-free survival (PFS) endpoint—which measures the time a patient lives without their disease getting worse—Enhertu yielded a 12-month PFS rate of 61.6% in patients with brain metastases at baseline, AZ and Daiichi said in a release. Further, patients with brain metastases showed a central nervous system (CNS) 12-month PFS rate of 58.9%.The results were consistent across patients with stable and active brain metastases, the partners added.Specifically, those with stable brain metastases achieved a 12-month PFS rate of 62.9% on Enhertu and a 12-month CNS PFS rate of 57.8%. Alternately, patients with active brain metastases had a 12-month PFS rate of 59.6% and a 12-month CNS PFS rate of 60.1%.The 12-month PFS for patients with brain metastases in DESTINY-Breast12 was roughly in line with the 72% observed in an exploratory analysis of a small group of similar patients enrolled in DESTINY-Breast03 that got Enhertu its approval in previously treated HER2-positive breast cancer, the trial investigators noted in the Nature Medicine study.Being able to show some CNS activity could help Enhertu in its competition with Pfizer’s small-molecule drug Tukysa, which was obtained in the New York pharma’s acquisition of Seagen.In the phase 2 HER2CLIMB study conducted in patients with heavily pretreated HER2-positive breast cancer, Tukysa's combination with chemo and trastuzumab delivered a median CNS PFS of 9.6 months in patients with active brain metastases, or 13.9 months in those with stable brain metastases.Up to 50% of patients with HER2-positive metastatic breast cancer see their disease spread to the brain over time, in turn significantly impacting quality of life and disease outcomes, Dana-Farber’s Nancy Lin, M.D., who served as the principal investigator for DESTINY-Breast12, pointed out in a statement.“Treating brain metastases in patients with breast cancer is challenging as there are few effective treatment options,” Mark Rutstein, global head of oncology development at Daiichi, said in a separate statement. “Building on previous studies, these results show Enhertu can provide strong overall and intracranial clinical activity and support its potential role in treating patients with active or stable brain metastases.”The data boost comes as Enhertu's sales growth has slowed down in recent months. In July, Daiichi and AZ reported combined Enhertu sales of $893 million for 2024’s second quarter, reflecting a scant 1.6% sequential increase from the first three months of the year. Even still, AZ’s oncology business chief Dave Fredrickson at the time said the British drugmaker expects Enhertu to return to “more robust sequential growth” in the second half of the year.Enhertu is one of six marketed products that AZ expects could reach more than $5 billion in global sales at peak.

Clinical ResultDrug ApprovalADCPhase 2

04 Sep 2024

·www.globenewswire.com

Context Therapeutics Appoints Dr. Karen Smith and Dr. Luke Walker to Board of Directors

The appointments of Dr. Karen Smith and Dr. Luke Walker to the Board bring extensive operational and clinical development experience to support corporate and pipeline strategyPHILADELPHIA, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced the appointments of Karen Smith, MD, PhD, MBA, LLM and Luke Walker, MD, to its Board of Directors. “Karen and Luke’s vast experience and proven leadership in the biopharmaceutical industry are tremendous assets for Context at this pivotal stage of our growth," said Martin Lehr, CEO of Context Therapeutics. “Karen’s extensive oncology drug development, regulatory, and strategy experience will be invaluable as Context continues to advance its pipeline. Luke brings an extensive track record in oncology drug development, including recent experience developing T cell engaging bispecific antibodies.” Mr. Lehr continued, “These additions supplement our ongoing effort to build Context into a leading oncology company and advance potential best-in-class T cell engaging bispecifics.” Dr. Karen Smith is a biopharmaceutical thought leader with over 20 years of experience bringing drugs into the clinic and through commercialization. She has been a key contributor to the successful development of multiple approved products in several therapeutic areas, including oncology (Herceptin, Vyxeos), rare disease (Defitelio), cardiology (Irbesartan), dermatology (Voluma, Botox), neuroscience (Abilify) and anti-infectives (Teflaro). Previously, she was Global Head of Research & Development and Chief Medical Officer of Jazz Pharmaceuticals. Earlier in her career, Dr. Smith held senior leadership roles at Allergan, AstraZeneca, and Bristol Myers Squibb. Previously, Dr. Smith served on the Board of Directors of Antares Pharma (acquired by Halozyme for $960 million), Acceleron Pharma (acquired by Merck for $11.5 billion), Mariana Oncology (acquired by Novartis for $1 billion upfront), and Sucampo Pharmaceuticals (acquired by Mallinckrodt for $1.2 billion). Dr. Smith currently serves on the Board of Directors of Aurinia Pharmaceuticals, Capstan Therapeutics, Sangamo Therapeutics, and Skye Bioscience. Dr. Luke Walker has more than 20 years of clinical development experience as both an executive and board member. Most recently, he was the Chief Medical Officer of Harpoon Therapeutics, an oncology-focused biopharmaceutical company where he was responsible for oversight of all aspects of clinical development programs using Harpoon’s TriTAC T-cell engager platform, which was acquired by Merck in 2024 for $680 million. Previously, Dr. Walker was Vice President of Clinical Development at Seagen, where he was the global development lead for Tukysa (tucatinib) through the program’s successful completion of a pivotal registrational trial and successful regulatory approvals. Earlier, Dr. Walker was Senior Vice President of Clinical Development at Cascadian Therapeutics, which was acquired by Seagen in 2018 for $614 million. Dr. Walker began his career as a practicing medical oncologist and hematologist at Providence Regional Medical Center and with the Everett Clinic. Dr. Walker currently serves on the Board of Directors of Zentalis Pharmaceuticals. About Context Therapeutics®Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing medicines for solid tumors. The Company is building an innovative portfolio of clinical-stage T cell engaging bispecific therapeutics, including CTIM-76, a Claudin 6 (CLDN6) x CD3 bispecific antibody, and CT-95, a Mesothelin (MSLN) 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 ability of the Company to become a leading oncology company; (iii) the potential benefits, characteristics, safety and side effect profile of our product candidates, (iv) 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, (v) the likelihood data will support future development of our product candidates, and (vi) 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

Executive ChangeAcquisitionCell TherapyImmunotherapy

100 Deals associated with Tucatinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11141	Tucatinib	L01	DB11652

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
HER2 Positive Colorectal Cancer	US	Seagen Inc.	19 Jan 2023
Metastatic breast cancer	CH	Seagen Inc.	07 May 2020
HER2 Positive Breast Cancer	US	Seagen Inc.	17 Apr 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Colorectal Carcinoma	Phase 3	US	Seagen Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	CN	Seagen Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	JP	Seagen Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	AR	Seagen Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	AU	Seagen Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	AT	Seagen Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	BE	Seagen Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	BR	Seagen Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	CA	Seagen Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	CL	Seagen Inc.	24 Oct 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04499924 (MOUNTAINEER-02, CTgov)	Phase 2/3	HER2 Positive Gastroesophageal Adenocarcinoma \| Adenocarcinoma of Esophagus \| Locally Advanced Gastroesophageal Junction Adenocarcinoma ... View more	17	Paclitaxel (Paclitaxel 60 mg/m^2)	llhhletqfx(lbnuygsdfa) = nkihrrvycn chaktnthxf (bjaepwxhwm, ffnjtiznis - zyxnmmgzjf) View more	-	22 Jan 2025
				Paclitaxel (Paclitaxel 80 mg/m^2)	llhhletqfx(lbnuygsdfa) = trkaesjfxe chaktnthxf (bjaepwxhwm, erzmgvkfrp - hyvcwupqin) View more
NCT04579380 (SGNTUC-019, Pubmed \| Nat Med) Manual	Phase 2	Metastatic breast cancer HER2 Positive	31	Tucatinib + Trastuzumab	hwpxrssihg(lhevtdvbro) = ksjktobiyt udpnfzieas (xdksfiqfnk, 26.9 - 58.2) View more	Positive	17 Jan 2025
NCT04579380 (SGNTUC-019, CTgov)	Phase 2	Locally Advanced Malignant Solid Neoplasm \| Hormone receptor positive breast cancer \| Breast Cancer ... View more	217	Tucatinib+Trastuzumab (Tucatinib+Trastuzumab (Cohort 1))	zmlmegbwrp(xxagwvpeou) = bmquujglvc bnhjowjykw (gbektcginy, jqinrrjtnj - vfdgfnqlpv) View more	-	13 Nov 2024
				Tucatinib+Trastuzumab (Tucatinib+Trastuzumab (Cohort 2))	zmlmegbwrp(xxagwvpeou) = wgbphvjfbt bnhjowjykw (gbektcginy, hxpxbczlxj - csgwfztnun) View more
ACTRN12620000767909 (ESMO2024) Manual	Phase 2	HER2 Positive Cancer ERBB2 Amplification \| ERBB2 Mutation (Activating)	31	Tucatinib trastuzumabumab	kbfdguhewt(bpqhredzzc) = ptwcvekheg lgnnjaueow (tctqylxegi ) View more	Positive	14 Sep 2024
				Tucatinibtrastuzumab	kbfdguhewt(bpqhredzzc) = nmlmegbjhj lgnnjaueow (tctqylxegi ) View more
NCT04721977 (MK-7119-001, CTgov)	Phase 2	Locally Advanced Unresectable Breast Carcinoma	66	Trastuzumab+Tucatinib+Capecitabine	vbzupvhjgs(ojttieabzq) = tfrkkviqzi tfqvruzigd (cyjllubdah, ybibxjbbnf - tqbmqlrhzk) View more	-	09 Aug 2024
NCT03975647 (HER2CLIMB-02, CTgov)	Phase 3	Metastatic HER2-Negative Breast Carcinoma \| Metastatic human epidermal growth factor 2 positive carcinoma of breast	466	Ado-trastuzumab Emtansine+Tucatinib (Tucatinib+ Ado-trastuzumab Emtansine)	pmnaogwbzg(dvtdxgnlqb) = awcnoebwdn ikqixavphl (gntizracgb, ybuzdpfjbx - hytwamxjdp) View more	-	30 Jul 2024
				Ado-trastuzumab Emtansine (Placebo+ Ado-trastuzumab Emtansine)	pmnaogwbzg(dvtdxgnlqb) = kdgthpxqkq ikqixavphl (gntizracgb, pfctbxuhjx - iqlziprlpc) View more
NCT03043313 (MOUNTAINEER, ASCO2024) Manual	Phase 2	HER2 Positive Colorectal Cancer RAS Wild Type \| HER2 Positive	116	Tucatinib + Trastuzumab	isalxwhcca(wrdmujceln) = srhrolbmst txecbjxvii (gztocvpfgo, 18.7 - 28.3) View more	Positive	24 May 2024
				Tucatinib monotherapyTrastuzumab	isalxwhcca(wrdmujceln) = pecgypagot txecbjxvii (gztocvpfgo, 17.0 - NE) View more
NCT03501979 (TBCRC049, ASCO2024) Manual	Phase 2	HER2 Positive Breast Cancer HER2 Positive	17	Tucatinib-trastuzumab-capecitabine	qozwpvtlig(dslfxwudnz) = ynbcbxrtlo amekdnbnqk (zbkdvkajsy ) View more	Positive	24 May 2024
NCT04579380 (SGNTUC-019, ASCO2024)	Phase 2	Metastatic breast cancer HER2 mutations \| HR+	31	Tucatinib 300 mg orally twice a day + Trastuzumab 8 mg/kg IV followed by 6 mg/kg every 3 wks	kpkhosyhws(psapejrouw) = vdpdgmuptz ccjqhcnele (gbndfjpvro, 26.9 - 58.2) View more	Positive	24 May 2024
NCT03043313 (MOUNTAINEER, Pubmed \| Future Oncol)	Phase 2	Metastatic Colorectal Carcinoma HER2-positive	117	Tucatinib with Trastuzumab	afcpurlmew(kskgkdthmq) = wpofhiwidr tdlsyhwvuw (osqbpcpuci ) View more	Positive	01 Mar 2024
				Tucatinib alone	cuxdgpburk(jmvgraaeja) = tsexbfvgyf axojmlpicp (tisnuccsgr )

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