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

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

Not yet recruiting

Conditions: Metastatic HER2+ Advanced Breast Cancer

Interventions: Drug: Tucatinib
Drug: Trastuzumab
Drug: Capecitabine

First Posted Date: 2025-05-07

Last Posted Date: 2025-05-07

Lead Sponsor: Pfizer

Target Recruit Count: 1

Registration Number: NCT06961331

Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)

Phase 1

Recruiting

Conditions: Breast Neoplasms
Breast Cancer

Interventions: Biological: Patritumab deruxtecan
Biological: Trastuzumab
Biological: Trastuzumab Biosimilar
Biological: Pertuzumab
Biological: Tucatinib

First Posted Date: 2024-11-13

Last Posted Date: 2025-05-16

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 81

Registration Number: NCT06686394

Locations: 🇺🇸
Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053), Greenville, South Carolina, United States
🇰🇷
Seoul National University Hospital ( Site 0030), Seoul, Korea, Republic of
🇺🇸
Rutgers Cancer Institute of New Jersey ( Site 0052), New Brunswick, New Jersey, United States

and more 3 locations

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

Phase 2

Recruiting

Conditions: Stage IV Breast Cancer
Breast Cancer Metastatic
Breast Cancer Female
Breast Cancer
Estrogen Receptor-positive Breast Cancer
HER2-positive Breast Cancer

Interventions: Drug: Nab-Paclitaxel
Drug: Paclitaxel
Drug: Docetaxel
Drug: Phesgo
Drug: T-DM1
Drug: Pertuzumab
Drug: Trastuzumab Deruxtecan
Drug: Trastuzumab Subcutaneous Subcutaneous
Drug: Tucatinib
Drug: Trastuzumab

First Posted Date: 2024-06-03

Last Posted Date: 2025-04-03

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 72

Registration Number: NCT06439693

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study

Phase 1

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Tucatinib
Drug: Trastuzumab
Drug: Pertuzumab

First Posted Date: 2023-12-08

Last Posted Date: 2024-01-11

Lead Sponsor: The Netherlands Cancer Institute

Target Recruit Count: 30

Registration Number: NCT06162559

Locations: 🇳🇱
Netherlands Cancer Institute, Amsterdam, Netherlands

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

Phase 2

Recruiting

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: Drug: disitamab vedotin
Drug: tucatinib

First Posted Date: 2023-12-06

Last Posted Date: 2025-05-13

Lead Sponsor: Seagen, a wholly owned subsidiary of Pfizer

Target Recruit Count: 172

Registration Number: NCT06157892

Locations: 🇪🇸
Ecg Medica Sl, Valencia, Spain
🇺🇸
Arizona Cancer Center / University of Arizona, Tucson, Arizona, United States
🇺🇸
Banner-University Medical Center Tucson Campus, Tucson, Arizona, United States

and more 115 locations

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

Phase 1

Not yet recruiting

Conditions: Metastatic Lung Non-Small Cell Carcinoma
Recurrent Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8

Interventions: Biological: Cetuximab
Drug: Osimertinib
Drug: Tucatinib

First Posted Date: 2023-10-05

Last Posted Date: 2023-10-05

Lead Sponsor: Jonathan Riess

Target Recruit Count: 36

Registration Number: NCT06067776

Locations: 🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Tucatinib With Brain and/or Spinal XRT in Patients With HER2+ Metastatic Breast Cancer and LMD

Phase 2

Recruiting

Conditions: HER2-positive Breast Cancer
LMD

Interventions: Drug: Tucatinib 150 MG
Drug: Trastuzumab
Drug: Capecitabine
Radiation: Brain & Spinal Radiation

First Posted Date: 2023-08-29

Last Posted Date: 2025-01-29

Lead Sponsor: Sunnybrook Health Sciences Centre

Target Recruit Count: 30

Registration Number: NCT06016387

Locations: 🇨🇦
The Ottawa Hospital, Ottawa, Ontario, Canada
🇨🇦
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Tucatinib in Combination With Oral Etoposide andTrastuzumab in Patients With Metastatic HER2+ Breast Cancer

Phase 2

Recruiting

Conditions: HER2-positive Breast Cancer

Interventions: Drug: Tucatinib in Combination of Oral VP16 and trastuzumab

First Posted Date: 2023-07-21

Last Posted Date: 2025-03-27

Lead Sponsor: Institut Curie

Target Recruit Count: 66

Registration Number: NCT05955170

Locations: 🇫🇷
Centre Jean Perrin, Clermont-Ferrand, Clermont Ferrand, France
🇫🇷
CHU Amiens Picardie-Site Sud, Amiens, France
🇫🇷
Institut Sainte Catherine, Avignon, France

and more 9 locations

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

Phase 2

Recruiting

Conditions: Metastatic Breast Cancer

Interventions: Drug: Tucatinib

First Posted Date: 2023-06-07

Last Posted Date: 2024-08-09

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 28

Registration Number: NCT05892068

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center (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

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

Phase 1

Recruiting

Conditions: Metastatic Breast Cancer
Metastatic
Hormone Receptor-positive Breast Cancer
Hormone Receptor Negative Breast Carcinoma
HER2 Low Breast Cancer
HER2 Low Breast Carcinoma
HER2-positive Breast Cancer
Metastatic Cancer
HER2-negative Breast Cancer
Solid Tumor, Adult

Interventions: Drug: ALX148
Drug: Zanidatamab
Drug: Fam-Trastuzumab Deruxtecan-Nxki
Drug: Tucatinib

First Posted Date: 2023-05-22

Last Posted Date: 2025-04-04

Lead Sponsor: QuantumLeap Healthcare Collaborative

Target Recruit Count: 124

Registration Number: NCT05868226

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center, Birmingham, Alabama, United States
🇺🇸
The University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States

and more 4 locations

Drug Development Updates

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