A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations

Conditions

• Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• Trastuzumab deruxtecan — DRUG
  Trastuzumab deruxtecan (T-DXd) by intravenous infusion

Study Details

This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Pre-specified HER2 mutations will be locally assessed using NGS tests or alternative methods. Prior HER2 targeting therapy is permitted.

Key Dates

Start date

Dec 30, 2020

Status verified

Mar 2026

Primary completion

Jan 25, 2023

Completion

Jul 14, 2026

Study Design

Enrollment

102 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: T-DXd
  T-DXd monotherapy

Primary Outcome Measure

Confirmed Overall Response Rate (ORR) as Per RECIST v1.1 Using Independent Central Review (ICR) [ Time Frame: Tumor scans performed at screening,then every 6 weeks (q6w) +/- 1 week relative to date of first treatment administration until RECIST v1.1 objective PD, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months) ]

Locations (10)

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