Tucatinib

Generic Name: Tucatinib

Brand Names: Tukysa

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₄N_₈O_₂

CAS Number: 937263-43-9

Unique Ingredient Identifier: 234248D0HH

Background: Tucatinib is a kinase inhibitor drug used with trastuzumab and capecitabine in the treatment of unresectable or metastatic HER-2 positive breast cancer. It was developed by Seattle Genetics and approved by the FDA on April 17, 2020. Tucatinib is a promising new treatment for patients with metastatic breast cancer who have not responded adequately to other chemotherapy regimens.

Indication: 本品与曲妥珠单抗和卡培他滨联用治疗人类表皮生长因子受体2(HER2)阳性且已出现转移(如脑转移)或无法进行乳房切除术的乳腺癌成人患者，患者应接受过一种或多种抗HER2乳腺癌药物治疗。

Associated Conditions: Breast Cancer, Unresectable Breast Cancer, Wild-type RAS Metastatic Colorectal Cancer, Unresectable RAS Wild Type Colorectal Cancer

Clinical Trials

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

Phase 2

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Tucatinib
Drug: Doxil

First Posted Date: 2023-03-01

Last Posted Date: 2025-01-31

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 36

Registration Number: NCT05748834

Locations: 🇺🇸
Alliance Cancer Specialists, Bensalem, Pennsylvania, United States
🇺🇸
Maryland Oncology Hematology, Columbia, Maryland, United States
🇺🇸
SCRI Oncology Partners, Nashville, Tennessee, United States

and more 5 locations

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)

Phase 2

Recruiting

Conditions: Brain Metastases
Metastatic Solid Tumor

Interventions: Drug: Trastuzumab emtansine
Drug: Tucatinib

First Posted Date: 2023-01-06

Last Posted Date: 2025-04-06

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 30

Registration Number: NCT05673928

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

A Study of Tucatinib and Trastuzumab in People With Rectal Cancer

Phase 2

Recruiting

Conditions: Adenocarcinoma of the Rectum
HER2 Positive Rectal Adenocarcinoma
Rectal Adenocarcinoma
Rectal Cancer
Locally Advanced Rectal Adenocarcinoma

Interventions: Drug: Trastuzumab
Drug: Tucatinib

First Posted Date: 2023-01-05

Last Posted Date: 2025-05-20

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 37

Registration Number: NCT05672524

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States

and more 4 locations

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

Phase 2

Active, not recruiting

Conditions: HER2-positive Metastatic Breast Cancer
Locally Advanced HER2 Positive Breast Carcinoma

Interventions: Drug: Tucatinib
Drug: Trastuzumab
Drug: Vinorelbine

First Posted Date: 2022-10-17

Last Posted Date: 2025-04-01

Lead Sponsor: Spanish Breast Cancer Research Group

Target Recruit Count: 13

Registration Number: NCT05583110

Locations: 🇪🇸
Hospital Universitario de Jeréz De La Frontera, Cádiz, Andalucía, Spain
🇪🇸
Hospital Universitario Reina Sofía, Córdoba, Andalucía, Spain
🇪🇸
Hospital Universitario de Jaén, Jaén, Andalucía, Spain

and more 15 locations

Tucatinib+Trastuzumab+Eribulin in HER2+ MBC

Phase 2

Recruiting

Conditions: Breast Cancer
Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer

Interventions: Drug: Tucatinib
Drug: Eribulin
Drug: Trastuzumab

First Posted Date: 2022-07-14

Last Posted Date: 2025-01-13

Lead Sponsor: Criterium, Inc.

Target Recruit Count: 30

Registration Number: NCT05458674

Locations: 🇺🇸
University of Colorado, Aurora, Colorado, United States
🇺🇸
George Washington Medical Faculty Associates, Washington, District of Columbia, United States
🇺🇸
New Mexico Cancer Care Alliance, Albuquerque, New Mexico, United States

and more 3 locations

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

Phase 1

Active, not recruiting

Conditions: Metastatic HER2+ Advanced Breast Cancer
Breast Neoplasms
Gastric or Gastroesophageal Junction Adenocarcinoma (GEC)
Colorectal Cancer

Interventions: Drug: Tucatinib

First Posted Date: 2022-05-19

Last Posted Date: 2025-03-20

Lead Sponsor: Pfizer

Target Recruit Count: 25

Registration Number: NCT05382364

Locations: 🇨🇳
Harbin Medical University Cancer Hospital-oncology of department ( Site 0010), Harbin, Heilongjiang, China
🇨🇳
Hunan Cancer Hospital-Digestion and Urology ( Site 0008), Changsha, Hunan, China
🇨🇳
Jilin Cancer Hospital-oncology department ( Site 0007), Changchun, Jilin, China

and more 2 locations

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

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: Biological: Trastuzumab
Drug: Trifluridine and Tipiracil Hydrochloride
Drug: Tucatinib

First Posted Date: 2022-05-02

Last Posted Date: 2024-07-30

Lead Sponsor: Academic and Community Cancer Research United

Registration Number: NCT05356897

Locations: 🇺🇸
UC San Diego Moores Cancer Center, San Diego, California, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

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

Phase 2

Recruiting

Conditions: Brain Metastases
Human Epidermal Growth Factor 2 Positive Carcinoma of Breast
Advanced Breast Cancer

Interventions: Drug: Trastuzumab
Drug: Trastuzumab Emtansine (T-DM1)
Drug: Pertuzumab
Drug: Tucatinib

First Posted Date: 2022-04-12

Last Posted Date: 2025-03-12

Lead Sponsor: Carey Anders, M.D.

Target Recruit Count: 48

Registration Number: NCT05323955

Locations: 🇺🇸
University of California San Francisco, San Francisco, California, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
University of Michigan Health System, Ann Arbor, Michigan, United States

and more 5 locations

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

Phase 1

Recruiting

Conditions: Metastatic HER2-Positive Breast Carcinoma
Prognostic Stage IB Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB 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

Interventions: Other: Quality-of-Life Assessment
Drug: Fulvestrant
Drug: Carboplatin
Drug: Ribociclib
Drug: Docetaxel
Biological: Trastuzumab
Biological: Pertuzumab
Drug: Tucatinib

First Posted Date: 2022-04-08

Last Posted Date: 2025-05-13

Lead Sponsor: Jonsson Comprehensive Cancer Center

Target Recruit Count: 18

Registration Number: NCT05319873

Locations: 🇺🇸
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

Tucatinib in Patients With Locally Advanced or Metastatic HER2-positive Breast Cancer Who Received at Least Two Prior Anti-HER2 Treatment Regimens.

Recruiting

Conditions: HER2-positive Breast Cancer

Interventions: Drug: TUKYSA®

First Posted Date: 2022-02-24

Last Posted Date: 2024-10-17

Lead Sponsor: iOMEDICO AG

Target Recruit Count: 300

Registration Number: NCT05253911

Locations: 🇩🇪
Universitätsklinikum Essen, Innere Klinik (Tumorforschung), Essen, Northrhine-Westphalia, Germany
🇦🇹
Medizinische Universität Wien, Innere Medizin I, Hämatologie und Onkologie, Vienna, Austria

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