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Showing 1–24 of 49 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: tucatinib Clear all
Completed No phase listed Observational

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

NCT06961331
View directory record Official record
Conditions
Metastatic HER2+ Advanced Breast Cancer
Interventions
Tucatinib, Trastuzumab, Capecitabine
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older
Enrollment
86 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jan 8, 2026 · Synced Sep 2, 2026, 5:23 AM EDT
Completed Phase 1 Interventional

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

NCT01983501
View directory record Official record
Conditions
HER2 Positive Breast Cancers
Interventions
Tucatinib (ONT-380), T-DM1
Drug
Lead sponsor
Seagen Inc.
Industry
Eligibility
18 Years and older
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2020
U.S. locations
7
States / cities
Birmingham, Alabama • Aurora, Colorado • Kansas City, Kansas + 4 more
Source: ClinicalTrials.gov public record
Updated Sep 20, 2020 · Synced Sep 2, 2026, 5:23 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

NCT04579380
View directory record Official record
Conditions
Uterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Urologic Neoplasms, Carcinoma, Non-Small-Cell Lung, HER2 Mutations Breast Neoplasms
Interventions
tucatinib, trastuzumab, fulvestrant
Drug
Lead sponsor
Seagen, a wholly owned subsidiary of Pfizer
Industry
Eligibility
18 Years and older
Enrollment
217 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
76
States / cities
Phoenix, Arizona • Tempe, Arizona • Tucson, Arizona + 47 more
Source: ClinicalTrials.gov public record
Updated Aug 20, 2026 · Synced Sep 2, 2026, 5:23 AM EDT
Active, not recruiting Phase 1Phase 2 Interventional

Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.

NCT05230810
View directory record Official record
Conditions
HER2-positive Metastatic Breast Cancer
Interventions
Alpelisib, Tucatinib, Fulvestrant
Drug
Lead sponsor
Criterium, Inc.
Industry
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
4
States / cities
Aurora, Colorado • Fort Collins, Colorado • New Orleans, Louisiana + 1 more
Source: ClinicalTrials.gov public record
Updated Mar 15, 2026 · Synced Sep 2, 2026, 5:23 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Effects of Tucatinib on Cardiac Repolarization in Healthy Participants

NCT03777761
View directory record Official record
Conditions
Healthy
Interventions
tucatinib, placebo, moxifloxacin
Drug
Lead sponsor
Seagen Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
55 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2019
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Apr 11, 2019 · Synced Sep 2, 2026, 5:23 AM EDT
Recruiting Early Phase 1 Interventional

Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy

NCT06828588
View directory record Official record
Conditions
Locally Advanced Cancer, Metastatic Cancer, HER2, HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, HER 2 Low-expressing Breast Cancer
Interventions
[68Ga]Ga-ABY-025
Drug
Lead sponsor
Vanderbilt-Ingram Cancer Center
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated May 7, 2026 · Synced Sep 2, 2026, 5:23 AM EDT
Active, not recruiting Phase 1Phase 2 Interventional

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

NCT05319873
View directory record Official record
Conditions
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced HER2-Positive Breast Carcinoma, Metastatic HER2-Positive Breast Carcinoma, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8
Interventions
Carboplatin, Docetaxel, Fulvestrant, Pertuzumab, Quality-of-Life Assessment, Ribociclib, Trastuzumab, Tucatinib
Drug · Biological · Other
Lead sponsor
Jonsson Comprehensive Cancer Center
Other
Eligibility
18 Years and older
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2028
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated May 10, 2026 · Synced Sep 2, 2026, 5:23 AM EDT
Active, not recruiting Phase 2 Interventional

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

NCT05190445
View directory record Official record
Conditions
HER2-positive Gastric Cancer
Interventions
Cinrebafusp alfa (PRS-343) in combination with ramucirumab and paclitaxel, Cinrebafusp alfa (PRS-343) in combination with tucatinib
Drug
Lead sponsor
Pieris Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
4
States / cities
Santa Barbara, California • Silver Spring, Maryland • New York, New York + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 7, 2022 · Synced Sep 2, 2026, 5:23 AM EDT
Not yet recruiting Phase 1 Interventional

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

NCT06067776
View directory record Official record
Conditions
Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
Interventions
Cetuximab, Osimertinib, Tucatinib
Biological · Drug
Lead sponsor
Jonathan Riess
Other
Eligibility
18 Years and older
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Oct 4, 2023 · Synced Sep 2, 2026, 5:23 AM EDT
Active, not recruiting Phase 2 Interventional Results available

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

NCT04430738
View directory record Official record
Conditions
Colorectal Carcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Esophageal Adenocarcinoma, Cholangiocarcinoma, Gallbladder Carcinoma
Interventions
tucatinib, trastuzumab, oxaliplatin, leucovorin, fluorouracil, capecitabine, pembrolizumab
Drug
Lead sponsor
Seagen, a wholly owned subsidiary of Pfizer
Industry
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
21
States / cities
Phoenix, Arizona • Scottsdale, Arizona • Aurora, Colorado + 10 more
Source: ClinicalTrials.gov public record
Updated Feb 23, 2026 · Synced Sep 2, 2026, 5:23 AM EDT
Active, not recruiting Phase 2 Interventional

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
View directory record Official record
Conditions
Brain Metastases, Human Epidermal Growth Factor 2 Positive Carcinoma of Breast, Advanced Breast Cancer
Interventions
Trastuzumab, Trastuzumab Emtansine (T-DM1), Pertuzumab, Tucatinib
Drug
Lead sponsor
Carey Anders, M.D.
Other
Eligibility
18 Years and older
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
8
States / cities
San Francisco, California • Boston, Massachusetts • Ann Arbor, Michigan + 5 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Sep 2, 2026, 5:23 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer

NCT04499924
View directory record Official record
Conditions
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
Interventions
tucatinib, trastuzumab, ramucirumab, paclitaxel, tucatinib placebo, trastuzumab placebo
Drug · Other
Lead sponsor
Seagen Inc.
Industry
Eligibility
18 Years and older
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
30
States / cities
Birmingham, Alabama • Phoenix, Arizona • Tucson, Arizona + 27 more
Source: ClinicalTrials.gov public record
Updated Jan 21, 2025 · Synced Sep 2, 2026, 5:23 AM EDT
Recruiting Phase 2Phase 3 Interventional

RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive

NCT07413939
View directory record Official record
Conditions
HER2-positive Breast Cancer
Interventions
RO7771950, Tucatinib, Trastuzumab, Capecitabine
Drug
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
18 Years and older
Enrollment
650 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2032
U.S. locations
1
States / cities
Germantown, Tennessee
Source: ClinicalTrials.gov public record
Updated Aug 4, 2026 · Synced Sep 2, 2026, 5:23 AM EDT
Active, not recruiting Phase 2 Interventional

A Study of Tucatinib Given Before Surgery to People With HER2+ Cancers That Have Spread to the Brain

NCT05892068
View directory record Official record
Conditions
Metastatic Breast Cancer
Interventions
Tucatinib
Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older · Female only
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
7
States / cities
Basking Ridge, New Jersey • Middletown, New Jersey • Montvale, New Jersey + 4 more
Source: ClinicalTrials.gov public record
Updated Feb 12, 2026 · Synced Sep 2, 2026, 5:23 AM EDT
Withdrawn Phase 2 Interventional

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

NCT05356897
View directory record Official record
Conditions
Metastatic Colon Adenocarcinoma, Metastatic Colorectal Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Stage IV Colon Cancer AJCC V8, Stage IV Colorectal Cancer AJCC V8, Stage IV Rectal Cancer AJCC V8
Interventions
Trastuzumab, Trifluridine and Tipiracil Hydrochloride, Tucatinib
Biological · Drug
Lead sponsor
Academic and Community Cancer Research United
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
2
States / cities
San Diego, California • Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Sep 18, 2024 · Synced Sep 2, 2026, 5:23 AM EDT
Active, not recruiting Phase 1 Interventional

First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer

NCT06239467
View directory record Official record
Conditions
Advanced Cancer, Breast Cancer, Advanced Solid Tumors, PI3K Gene Mutation
Interventions
OKI-219, Fulvestrant, Trastuzumab, Tucatinib, Atirmociclib, Ribociclib
Drug
Lead sponsor
OnKure, Inc.
Industry
Eligibility
18 Years and older
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
12
States / cities
Encinitas, California • La Jolla, California • Los Angeles, California + 9 more
Source: ClinicalTrials.gov public record
Updated Jul 5, 2026 · Synced Sep 2, 2026, 5:23 AM EDT
Active, not recruiting Phase 2 Interventional

A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors

NCT06157892
View directory record Official record
Conditions
Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma, HER2 Low Breast Neoplasms, HER2 Positive Breast Neoplasms, Stomach Neoplasms, Triple Negative Breast Neoplasms, Metastatic Breast Cancer, Metastatic Gastric Cancer, Advanced Breast Cancer, Advanced Gastric Cancer
Interventions
disitamab vedotin, tucatinib
Drug
Lead sponsor
Seagen, a wholly owned subsidiary of Pfizer
Industry
Eligibility
18 Years and older
Enrollment
54 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
77
States / cities
Tucson, Arizona • Orange, California • San Francisco, California + 39 more
Source: ClinicalTrials.gov public record
Updated Jul 21, 2026 · Synced Sep 2, 2026, 5:23 AM EDT
Recruiting Phase 2 Interventional

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

NCT06439693
View directory record Official record
Conditions
Breast Cancer Female, Breast Cancer, Breast Cancer Metastatic, Estrogen Receptor-positive Breast Cancer, HER2-positive Breast Cancer, Stage IV Breast Cancer
Interventions
Nab-Paclitaxel, Paclitaxel, Docetaxel, Phesgo, T-DM1, Pertuzumab, Trastuzumab Deruxtecan, Trastuzumab Subcutaneous Subcutaneous, Tucatinib, Trastuzumab
Drug
Lead sponsor
Dana-Farber Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
72 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2033
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Aug 5, 2026 · Synced Sep 2, 2026, 5:23 AM EDT
Withdrawn Phase 1Phase 2 Interventional

TOPAZ: Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases

NCT04512261
View directory record Official record
Conditions
Breast Cancer, Brain Metastases, HER2-positive Breast Cancer, CNS Disease
Interventions
Tucatinib, Pembrolizumab, Trastuzumab
Drug
Lead sponsor
Reva Basho
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Jun 30, 2022 · Synced Sep 2, 2026, 5:23 AM EDT
Completed Phase 2 Interventional Results available

Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer

NCT03043313
View directory record Official record
Conditions
Metastatic Colorectal Adenocarcinoma
Interventions
Trastuzumab, Tucatinib
Drug
Lead sponsor
Seagen Inc.
Industry
Eligibility
18 Years and older
Enrollment
117 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2023
U.S. locations
41
States / cities
Birmingham, Alabama • Gilbert, Arizona • Phoenix, Arizona + 34 more
Source: ClinicalTrials.gov public record
Updated Nov 25, 2024 · Synced Sep 2, 2026, 5:23 AM EDT
Withdrawn Phase 1Phase 2 Interventional

Tucatinib With Chemotherapy and Trastuzumab in Advanced Her-2-neu Overexpressing, Previously Treated Breast Cancer.

NCT04896320
View directory record Official record
Conditions
Breast Cancer Stage IV
Interventions
Tucatinib
Drug
Lead sponsor
Providence Health & Services
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
4
States / cities
Clackamas, Oregon • Newberg, Oregon • Portland, Oregon
Source: ClinicalTrials.gov public record
Updated Jun 21, 2023 · Synced Sep 2, 2026, 5:23 AM EDT
Completed Phase 1Phase 2 Interventional Results available

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

NCT03054363
View directory record Official record
Conditions
Breast Cancer
Interventions
Tucatinib in Combination with Palbociclib and Letrozole
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years to 100 Years · Female only
Enrollment
42 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2023
U.S. locations
6
States / cities
Tucson, Arizona • Aurora, Colorado • Chicago, Illinois + 3 more
Source: ClinicalTrials.gov public record
Updated Nov 12, 2023 · Synced Sep 2, 2026, 5:23 AM EDT
Recruiting Phase 2 Interventional

A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)

NCT05673928
View directory record Official record
Conditions
Metastatic Solid Tumor, Brain Metastases
Interventions
Trastuzumab emtansine, Tucatinib
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2029
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 15, 2026 · Synced Sep 2, 2026, 5:23 AM EDT
Recruiting Phase 1 Interventional

PRE-I-SPY Phase I/Ib Oncology Platform Program

NCT05868226
View directory record Official record
Conditions
HER2-positive Breast Cancer, Metastatic Cancer, Metastatic Breast Cancer, Metastatic, HER2-positive Metastatic Breast Cancer, HER2 Mutation-Related Tumors, HER-2 Protein Overexpression, HER2-negative Breast Cancer, Triple Negative Breast Cancer, HR Positive, Hormone Receptor-positive Breast Cancer, Estrogen Receptor Positive Tumor, Progesterone Receptor-positive Breast Cancer, Hormone Receptor Negative Breast Carcinoma, Solid Tumor, Solid Tumor, Adult, Solid Carcinoma, HER2 Low Breast Cancer, HER2 Low Breast Carcinoma, ER Positive Breast Cancer, PR-positive Breast Cancer
Interventions
ALX148, Fam-Trastuzumab Deruxtecan-Nxki, Zanidatamab, Tucatinib
Drug
Lead sponsor
QuantumLeap Healthcare Collaborative
Other
Eligibility
18 Years and older
Enrollment
124 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2029
U.S. locations
7
States / cities
Birmingham, Alabama • Tampa, Florida • Chicago, Illinois + 4 more
Source: ClinicalTrials.gov public record
Updated Apr 3, 2025 · Synced Sep 2, 2026, 5:23 AM EDT