A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumors With HER2 Abnormalities, Advanced Solid Tumors With HER3 Abnormalities

In brief

This is a First-in-Human (FIH), 2-part, Phase 1/2, open-label, multicenter study design to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728. This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors with HER2 or HER3 overexpression, amplification, or mutation who have progressed despite standard therapy or for which no standard therapy exists, particularly urothelial cancer, biliary tract cancer, metastatic breast cancer, non-small cell lung cancer and colorectal cancer.

Key facts

Study ID

NCT03410927

Run by

Taiho Oncology, Inc.

People needed

19

Starts

2018-04-06

Expected to finish

2022-06-09

Last updated by the study team

2024-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or females with an age ≥ 18 years.
• Subjects with histological- or cytological-confirmed, advanced cancer, who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists
• For Phase 1, only subjects HER2 or HER3 molecular/genetic alterations will be enrolled.
• For Phase 2a, subjects with one of the following tumor types will be enrolled:
• i. Urothelial cancer with HER2 or HER3 mutation ii. Biliary tract cancer with HER2 or HER3 mutation iii. Breast cancer with HER2 or HER3 mutation iv. Breast cancer with HER2 amplification or overexpression v. NSCLC with HER2 or HER3 mutation vi. CRC with HER2 mutation or amplification vii. Other tumors with HER2 mutation/amplification/overexpression or HER3 mutation (gastric/GEJ, endometrial).
• At least 1 measurable lesion for solid tumor
• Is able to take medications orally (e.g., no feeding tube).
• Able to agree to and sign informed consent and to comply with the protocol
• Has adequate organ function

You may not qualify if…

• Has a serious illness or medical condition(s)
• Has received treatment with any proscribed treatments within specified time frames prior to study drug administration
• Impaired cardiac function or clinically significant cardiac disease

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Sarah Cannon — Nashville, Tennessee, United States
• University of Texas - MD Anderson — Houston, Texas, United States
• Institut de Cancerologie Gustavo Roussy — Paris, France
• Hospital Vall D'hebron — Barcelona, Spain
• Sarah Cannon Research Institute - UK — London, United Kingdom

Full record on ClinicalTrials.gov

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