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Small Molecule Inhibitor

TAS0728 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Taiho Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing a new drug, TAS0728, to see if it is safe and effective in treating subjects with advanced solid tumors that have overexpression, amplification, or mutation of HER2 or HER3.

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Phase 1 and 2)
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.
Objective Response Rate using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) (Phase2)
Secondary outcome measures
Area under the plasma drug concentration-time curve (AUC) after administration of TAS0728 (Phase 1)
Disease Control Rate using RECIST 1.1 (phase 1 and 2)
Duration of response (phase 1 and 2)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TAS0728Experimental Treatment1 Intervention
Group 1: Urothelial cancer with HER2 or HER3 mutation Group 2: Biliary tract cancer with HER2 or HER3 mutation Group 3: Breast cancer with HER2 or HER3 mutation Group 4: Breast cancer with HER2 amplification or overexpression as per American Society of Clinical Oncology - College of American Pathologists (ASCO-CAP) 2013 guidelines Group 5: Non-small cell lung cancer (NSCLC) with HER2 or HER3 mutation Group 6: Colorectal cancer (CRC) with HER2 mutation or amplification Group 7: Other tumors with HER2 or HER3 mutation, amplification, or overexpression (eg, gastric or gastroesophageal junction (GEJ), endometrial)

Find a Location

Who is running the clinical trial?

Taiho Oncology, Inc.Lead Sponsor
66 Previous Clinical Trials
11,565 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities
2018. "A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03410927.
~3 spots leftby Apr 2025
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