Status:
TERMINATED
A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities
Lead Sponsor:
Taiho Oncology, Inc.
Conditions:
Advanced Solid Tumors With HER2 Abnormalities
Advanced Solid Tumors With HER3 Abnormalities
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03410927
Start Date
April 6 2018
End Date
June 9 2022
Last Update
September 5 2024
Active Locations (8)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
2
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029-6504
4
Sarah Cannon
Nashville, Tennessee, United States, 37203