Clinical Trials

Breast Neoplasms

NCT05253651 2026-03-16

MOUNTAINEER-03

Phase 3 Recruiting

400 enrolled

Colorectal Neoplasms

NCT01042379 2026-03-13

I-SPY

Phase 1 Active not recruiting

5,000 enrolled

BreastSarcoma

Pathologic Complete Response, Breast Neoplasms, Hemangiosarcoma, Neoplasms, Triple Negative Breast Neoplasms

NCT05382364 2026-03-12

Safety and Pharmacokinetics of Tucatinib (MK-7119) in Chinese Participants With Cancer (MK-7119-002)

25 enrolled

BreastGastrointestinal

Breast Neoplasms, Colorectal Neoplasms

NCT07413939 2026-03-10

BREnnA

Phase 2/3 Not yet recruiting

650 enrolled

HER2-positive Breast Cancer

NCT03297606 2026-03-04

CAPTUR

720 enrolled

LymphoidPlasma cell

Lymphoma, Non-Hodgkin, Multiple Myeloma

NCT05672524 2026-03-04

A Study of Tucatinib and Trastuzumab in People With Rectal Cancer

37 enrolled

Phase EARLY_PHASE1 Not yet recruiting

Adenocarcinoma, Rectal Neoplasms

NCT07318389 2026-02-27

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

100 enrolled

Colorectal Neoplasms

NCT04430738 2026-02-24

Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers

40 enrolled 67 charts

Adenocarcinoma Of Esophagus, Esophageal Neoplasms, Gallbladder Neoplasms, Stomach Neoplasms, Colorectal Neoplasms, Cholangiocarcinoma

NCT06016387 2026-02-23

Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 Mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study

30 enrolled

Breast Neoplasms, Meningeal Neoplasms

NCT07193394 2026-02-23

H3RAKLES

20 enrolled

Breast Neoplasms, Neoplasm Metastasis, Neoplasms

NCT02693535 2026-02-13

TAPUR

4,200 enrolled

LymphoidPlasma cell

Lymphoma, Non-Hodgkin, Multiple Myeloma, Neoplasms

NCT06686394 2026-02-13

MK-1022-009

Phase 1/2 Recruiting

81 enrolled

Breast Neoplasms

NCT05062889 2026-02-03

ERASE-CRC

Phase 2 Suspended

477 enrolled

Colonic Neoplasms

NCT04721977 2026-01-09

MK-7119-001

66 enrolled 7 charts

Breast Neoplasms

NCT06961331 2026-01-09

Real World-clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan (T-DXd) for the Treatment of HER2-positive Metastatic Breast Cancer.

Completed

86 enrolled

Phase 3 Active not recruiting

Breast Neoplasms

NCT05553522 2025-12-31

Tucatinib, Trastuzumab, and Capecitabine With SRS for Brain Metastases From HER-2 Positive Breast Cancer

Phase 1 Terminated

1 enrolled

CNS

Brain Neoplasms

NCT03975647 2025-12-10

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

466 enrolled 17 charts

HER2-positive Breast Cancer

NCT05583110 2025-12-10

TrasTUCAN

Phase 2 Terminated

13 enrolled

Phase 1/2 Active not recruiting

Breast Neoplasms

NCT04538742 2025-12-08

DB-07

245 enrolled

Brain Neoplasms, Breast Neoplasms

NCT05253911 2025-12-04

TRACE

Completed

49 enrolled

HER2-positive Breast Cancer

NCT05041842 2025-11-17

InTTercePT

53 enrolled

Metastatic Breast Cancer With a Isolated Brain Progression

NCT04539938 2025-09-30

HER2CLIMB-04

Phase 2 Completed

70 enrolled 11 charts

Breast Neoplasms

NCT06239467 2025-09-09

PIKture-01

Phase 1 Recruiting

200 enrolled

Breast Neoplasms

NCT03501979 2025-08-29

Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD

Phase 2 Terminated

17 enrolled 16 charts

Breast Neoplasms, Meningeal Neoplasms

NCT04220203 2025-06-26

Treatment Protocol of Tucatinib With Capecitabine and Trastuzumab in Patients With Unresectable Previously Treated HER2+ Breast Cancer

Approved for marketing

HER2-positive Breast Cancer

NCT06439693 2025-06-26

The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer

72 enrolled

Breast Neoplasms

NCT05319873 2025-05-13

Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer

Phase 1/2 Recruiting

18 enrolled

Anatomic Stage II Breast Cancer AJCC v8

NCT05868226 2025-04-04

PRE-I-SPY-PI

Phase 1 Recruiting

124 enrolled

Breast Neoplasms, Neoplasm Metastasis, Triple Negative Breast Neoplasms

NCT05955170 2025-03-27

TUC-TOC

66 enrolled

HER2-positive Breast Cancer

NCT05748834 2025-01-31

Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer

36 enrolled

Breast Neoplasms

NCT04499924 2025-01-22

MOUNTAINEER-02

Phase 2/3 Completed

17 enrolled 23 charts

BreastGastrointestinalGynecologicThoracic

Adenocarcinoma Of Esophagus

NCT02892123 2024-11-27

Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

Phase 1 Completed

279 enrolled

Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasms, Ovarian Neoplasms, Stomach Neoplasms

NCT03043313 2024-11-26

Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer

Phase 2 Completed

117 enrolled 21 charts 1 FDA

Colorectal Neoplasms

NCT05356897 2024-09-19

Tucatinib Combined with Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study

Phase 2 Withdrawn

Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms

NCT06162559 2024-01-11

TRAIN-4

Phase 1 Recruiting

30 enrolled

Breast Neoplasms

NCT03054363 2023-11-13

Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer

Phase 1/2 Completed

42 enrolled 16 charts

Phase 1 Not yet recruiting

Breast Neoplasms

NCT06067776 2023-10-05

Osimertinib, Cetuximab, and Tucatinib for the Treatment of EGFR-Mutant Stage IV or Recurrent Non-small Lung Cell Cancer

36 enrolled

Thoracic

Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

NCT02614794 2023-08-14

HER2CLIMB

Phase 2 Completed

612 enrolled 30 charts 2 FDA

Brain Neoplasms, Breast Neoplasms

NCT04896320 2023-06-22

2019-101826

Phase 1/2 Withdrawn

Breast Neoplasms, Neoplasm Metastasis

NCT05190445 2022-09-08

Cinrebafusp Alfa in Combination With Ramucirumab and Paclitaxel in HER2-High Gastric or GEJ Adenocarcinoma and in Combination With Tucatinib in HER2-Low Gastric or GEJ Andenocarinoma

80 enrolled

BreastGastrointestinalThoracic

HER2-positive Gastric Cancer

NCT05091528 2022-08-18

A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers

Phase 1/2 Terminated

2 enrolled 9 charts

Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Colorectal Neoplasms

NCT05227131 2022-07-11

MARGARET

Phase 2 Withdrawn

Breast Neoplasms

NCT04512261 2022-07-01

TOPAZ

Phase 1/2 Withdrawn

Brain Neoplasms, Breast Neoplasms, Central Nervous System Diseases

NCT04760431 2021-06-02

TKIs vs. Pertuzumab in HER2+ Breast Cancer Patients With Active Brain Metastases (HER2BRAIN)

Phase 2 Unknown

120 enrolled

CNS

Brain Neoplasms

NCT03846583 2020-10-23

Tucatinib + Abemaciclib + Herceptin for HER2+ MBC

Phase 1 Withdrawn

Breast Neoplasms

NCT01983501 2020-09-21

A Study of Tucatinib (ONT-380) Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer

Phase 1 Completed

57 enrolled

Breast Neoplasms

NCT02025192 2020-06-04

A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer

Phase 1 Completed

60 enrolled

Breast Neoplasms

NCT03424473 2020-02-25

Expanded Access Use of Tucatinib for HER2+ Metastatic Breast Cancer

No longer available