A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities (NCT03410927) | Clinical Trial Compass
TerminatedPhase 1
A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities
Stopped: The study was stopped due to unacceptable toxicity during the dose-escalation portion (Phase 1) of the study and did not progress to Phase 2
United States19 participantsStarted 2018-04-06
Plain-language 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 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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 criteria
✕. Has a serious illness or medical condition(s)
✕. Has received treatment with any proscribed treatments within specified time frames prior to study drug administration
What they're measuring
1
Number of patients experiencing Dose Limiting Toxicity graded according to CTCAE Version 4.03, observed in the Cycle 1 in order to meet the objective of assessment of the MTD of TAS0728.
Timeframe: 21-day cycles
2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Phase 1 and 2)
Timeframe: Safety monitoring will begin at the informed consent obtained and continue up to 30 days after the last dose of TAS0728 or until new antitumor therapy, whichever is earlier.
3
Objective Response Rate using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) (Phase2)