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tucatinib

Generic: TUCATINIB·Brand: TUKYSA, Tukysa

tucatinib: 19 clinical trials tracked.

tucatinib evidence translation

What we can confirm

19 tracked trials

No verified listed developer

What it means

AI will separate confirmed drug evidence from unknown company context.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

What is verified about tucatinib, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 6 study sponsors
Clinical Trials (19)showing 10 most recent

A Multicenter, Open-label, Treatment Protocol of Tucatinib in Combination With Capecitabine and Trastuzumab in Patients With Previously Treated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma

Approved for marketing
Expanded AccessSeagen, a wholly owned subsidiary of Pfizer

ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer

NCT07318389·Early Phase 1·FATE
Not yet recruiting

Primary endpoint: safety and adverse events (AEs)

Interventionalopen100 targetStarted 2026-06Completion 2029-111 site · United StatesM.D. Anderson Cancer Center

A Two-part, Seamless, Multicenter, Randomized, Open-label, Adaptive Phase II/III Study of the Blood-brain Barrier Penetrant RO7771950 Versus Tucatinib, Both in Combination With Trastuzumab and Capecitabine, in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2-Postivie Breast Cancer, With or Without Central Nervous System Metastases

NCT07413939·Phase 2·ENTA
Not yet recruiting

Primary endpoint: Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR)

InterventionalRandomizedopen650 targetStarted 2026-04Completion 2032-08Hoffmann-La Roche

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

NCT06686394·Phase 1·MRK
Recruiting

Primary endpoint: Number of Participants Experiencing Dose-Limiting Toxicity (DLT)

Interventionalopen81 targetStarted 2025-02Completion 2030-0417 sites · Canada, Israel, Japan, South Korea…Merck Sharp & Dohme LLC

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

NCT06157892·Phase 2·PFE
Active, not recruiting

Primary endpoint: Number of participants with dose limiting toxicities (DLTs) in dose escalation phase

InterventionalRandomizedopen54 enrolledStarted 2024-05Completion 2029-0750 sites · United StatesSeagen, a wholly owned subsidiary of Pfizer

PIKture-01: First-in-Human Study of the PI3KαH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and as Part of Combination Therapy in Participants With Advanced Breast Cancer

NCT06239467·Phase 1·OKUR
Active, not recruiting

Primary endpoint: Identify maximum tolerated dose (MTD) of OKI-219 in monotherapy

InterventionalRandomizedopen200 targetStarted 2024-02Completion 2027-0833 sites · Belgium, France, Italy, South Korea…OnKure, Inc.

Phase 2 Single Arm Trial With a Safety Lead-in of Tucatinib in Combination With Doxil for the Treatment of HER2+ Metastatic Breast Cancer

NCT05748834·Phase 2
Recruiting

Primary endpoint: Objective response rate (ORR) to assess the anti-tumor activity of tucatinib in combination with Doxil using RECIST v1.1.

Interventionalopen36 targetStarted 2023-07Completion 2027-118 sites · United StatesSCRI Development Innovations, LLC

Window of Opportunity Analysis of Pre-Operative Tucatinib for Surgically Resected HER2+ Brain Metastases: Understanding Mechanisms of Resistance

NCT05892068·Phase 2
Active, not recruiting

Primary endpoint: Maximum observed plasma concentration (Cmax) of Tucatinib

Interventionalopen9 targetStarted 2023-05Completion 2028-057 sites · United StatesMemorial Sloan Kettering Cancer Center

Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib

NCT05323955·Phase 2
Active, not recruiting

Primary endpoint: Progression Free Survival (PFS)

Interventionalopen48 targetStarted 2023-03Completion 2027-118 sites · United StatesCarey Anders, M.D.

An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer

NCT05253651·Phase 3·PFE
Recruiting

Primary endpoint: Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR)

InterventionalRandomizedopen400 targetStarted 2022-10Completion 2030-0750 sites · United StatesSeagen, a wholly owned subsidiary of Pfizer