TUKYSA 150 mg film-coated tablets
Sponsors
Institut Curie, Unicancer, Seagen Inc., Fundacion Grupo Espanol De Investigacion En Cancer De Mama, Fundacion Grupo Espanol De Investigacion En Cancer De Mama, Medica Scientia Innovation Research S.L.
Conditions
HER2 positive advanced breast cancerHER2+ metastatic breast cancer with isolated brain progressionHER3-mutant and HER2-not amplified metastatic breast cancerLA/mGC/GEJC (locally advanced unresectable or metastatic gastric cancer and gastroesophageal junction adenocarcinomaLocally-Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 AlterationsMetastatic HER2+ Breast cancerNon-resectable locally advanced or metastatic HER2-positive breast cancerPatients having a HER2-amplified metastatic breast cancer with evolutive leptomeningeal metastases (LM) requiring intrathecal therapy
Phase 1
C5731004 - SGNDV-004 - A Phase 1b/2 Open-Label Study of Disitamab Vedotin in Combination with Other Anticancer Therapies in Solid Tumors
RecruitingCTIS2023-507555-29-00
Start: 2024-08-16Target: 68Updated: 2025-10-03
Single arm phase II study of the efficacy and safety of the combination of Trastuzumab plus TUCAtinib plus viNorelbine in patients with HER2-positive non-resectable locally advanced or metastatic breast cancer “TrasTUCAN Study”
CompletedCTIS2024-512590-27-00
Start: 2023-03-08End: 2025-05-30Target: 49Updated: 2024-06-19
PHASE IB/II STUDY TO EVALUATE SAFETY AND PRELIMINARY EFFICACY OF ZANIDATAMAB IN COMBINATION WITH TUCATINIB AND CHEMOTHERAPY (CAPECITABINE OR ERIBULIN MESYLATE) IN HER2-POSITIVE ADVANCED BREAST CANCER (The JAZMINE Study)
Not yet recruitingCTIS2025-524613-89-00
Target: 129Updated: 2026-05-05
Phase 2
"TUC-TOC": Tucatinib in combination with Oral Etoposide (VP16) - Trastuzumab in Patients with metastatic HER2+ Breast cancer after progression under Tucatinib-Capecitabine-Trastuzumab or toxicity related to capecitabine: a multicenter Phase II
RecruitingCTIS2022-500743-20-00
Start: 2023-12-19Target: 66Updated: 2025-02-27
ETIC-LM_Multicentric single arm phase II study evaluating the Efficacy of association of Tucatinib, capecitabine and Intra-CSF trastuzumab in HER2 amplified breast cancer patients with Leptomeningeal Metastases.
RecruitingCTIS2022-502351-60-00
Start: 2024-02-22Target: 30Updated: 2025-04-17
InTTercePT : Treatment with Tucatinib in addition to Pertuzumab and Trastuzumab in patients with HER2-positive metastatic breast cancer after local therapy of isolated brain progression
Active, not recruitingCTIS2024-510703-11-00
Start: 2021-12-13Target: 55Updated: 2026-01-12
C4251003- A Phase 2 Basket Study of Tucatinib in Combination with Trastuzumab in Subjects with Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations.
Active, not recruitingCTIS2024-511481-37-00
Start: 2021-07-12Target: 29Updated: 2025-06-17
"H3RAKLES": Tucatinib and trastuzumab in HER3-mutant and HER2-not amplified metastatic breast cancer
Not yet recruitingCTIS2024-519624-24-00
Target: 20Updated: 2025-09-11
Phase 3
A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic HER2+ breast cancer (HER2CLIMB-05)
Active, not recruitingCTIS2023-503826-37-00
Start: 2022-02-11Target: 249Updated: 2026-01-08
C4251008 - 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
RecruitingCTIS2024-514180-25-00
Start: 2022-11-21Target: 155Updated: 2025-12-05
Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer (HER2CLIMB-02)
Active, not recruitingCTIS2024-514733-38-00
Start: 2020-11-03Target: 101Updated: 2025-10-20