MedPath

Tucatinib

Generic Name
Tucatinib
Brand Names
Tukysa
Drug Type
Small Molecule
Chemical Formula
C26H24N8O2
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

A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

First Posted Date
2022-02-24
Last Posted Date
2025-05-20
Lead Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Target Recruit Count
400
Registration Number
NCT05253651
Locations
🇺🇸

Pacific Cancer Medical Center Inc., Anaheim, California, United States

🇺🇸

Palo Verde Hematology Oncology, Glendale, Arizona, United States

🇺🇸

Mayo Clinic Building - Phoenix, Phoenix, Arizona, United States

and more 344 locations

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

Phase 1
Recruiting
Conditions
HER2-positive Metastatic Breast Cancer
Interventions
First Posted Date
2022-02-09
Last Posted Date
2024-03-19
Lead Sponsor
Criterium, Inc.
Target Recruit Count
40
Registration Number
NCT05230810
Locations
🇺🇸

University of Colorado Cancer Center, Aurora, Colorado, United States

🇺🇸

University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States

🇺🇸

Louisiana State University Health Sciences Center, New Orleans, Louisiana, United States

and more 1 locations

Margetuximab Plus Tucatinib and Capecitabine in HER2-positive Metastatic Breast Cancer

Phase 2
Withdrawn
Conditions
Metastatic Breast Cancer
Advanced Breast Cancer
HER2-positive Breast Cancer
Interventions
First Posted Date
2022-02-07
Last Posted Date
2022-07-11
Lead Sponsor
MedSIR
Registration Number
NCT05227131

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

Phase 3
Active, not recruiting
Conditions
HER2 Positive Breast Cancer
Interventions
First Posted Date
2021-11-24
Last Posted Date
2025-05-20
Lead Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Target Recruit Count
650
Registration Number
NCT05132582
Locations
🇨🇱

James Lind Centro De Investigacion Del Cancer, Temuco, Chile

🇨🇳

The Second Hospital of Anhui Medical University, Hefei City, Anhui, China

🇩🇪

Universitatsklinikum Wurzburg Apotheke, Wurzburg, Germany

and more 377 locations

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

Phase 1
Terminated
Conditions
HER2-positive Gastric Cancer
HER2-positive Breast Cancer
HER2-expressing Non-small Cell Lung Cancer
HER2-positive Colorectal Cancer
Interventions
First Posted Date
2021-10-25
Last Posted Date
2022-08-18
Lead Sponsor
Silverback Therapeutics
Target Recruit Count
2
Registration Number
NCT05091528
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients

First Posted Date
2021-09-30
Last Posted Date
2025-02-17
Lead Sponsor
Gruppo Oncologico del Nord-Ovest
Target Recruit Count
477
Registration Number
NCT05062889
Locations
🇮🇹

Fondazione Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy

🇮🇹

Azienda Ospedaliera Cardinale Giovanni Panico, Tricase, Lecce, Italy

🇮🇹

Ospedale San Donato di Arezzo, Arezzo, Italy

and more 25 locations

Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer

Phase 2
Active, not recruiting
Conditions
Metastatic Breast Cancer With a Isolated Brain Progression
Interventions
First Posted Date
2021-09-13
Last Posted Date
2024-10-17
Lead Sponsor
UNICANCER
Target Recruit Count
53
Registration Number
NCT05041842
Locations
🇫🇷

Institut de Cancérologie de l'Ouest - Site Paul Papin, Angers, France

🇫🇷

Centre Francois Baclesse, Caen, France

🇫🇷

Centre Georges François Leclerc, Dijon, France

and more 12 locations

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

Phase 1
Withdrawn
Conditions
Breast Cancer Stage IV
Interventions
First Posted Date
2021-05-21
Last Posted Date
2023-06-22
Lead Sponsor
Providence Health & Services
Registration Number
NCT04896320
Locations
🇺🇸

Providence Newberg Medical Center, Newberg, Oregon, United States

🇺🇸

Portland Providence Medical Center, Portland, Oregon, United States

🇺🇸

Providence Cancer Institute - Clackamas Clinic, Clackamas, Oregon, United States

and more 1 locations

Tucatinib Together with Pembrolizumab and Trastuzumab

Phase 2
Recruiting
Conditions
Breast Cancer
HER2-positive Breast Cancer
Interventions
First Posted Date
2021-03-09
Last Posted Date
2025-02-05
Lead Sponsor
Breast Cancer Trials, Australia and New Zealand
Target Recruit Count
57
Registration Number
NCT04789096
Locations
🇦🇺

Peter MacCallum Cancer Centre, Parkville, Victoria, Australia

🇦🇺

Macquarie University, Macquarie Park, New South Wales, Australia

🇦🇺

Nepean Cancer Care Centre, Kingswood, New South Wales, Australia

and more 12 locations

A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001)

Phase 2
Active, not recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2021-01-25
Last Posted Date
2025-02-20
Lead Sponsor
Pfizer
Target Recruit Count
66
Registration Number
NCT04721977
Locations
🇰🇷

Seoul National University Hospital ( Site 2003), Seoul, Korea, Republic of

🇯🇵

National Cancer Center Hospital ( Site 1003), Tokyo, Japan

🇯🇵

Fukushima Medical University Hospital ( Site 1012), Fukushima, Japan

and more 25 locations
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