A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations - DPT01

Study identifier:D967MC00001

ClinicalTrials.gov identifier:NCT04639219

EudraCT identifier:2020-002368-30

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for the Treatment of Unresectable and/or Metastatic Solid Tumors Harboring HER2 Activating Mutations Regardless of Tumor Histology

Medical condition

Advanced solid tumors with HER2 mutation,eg:colorectal,urothelial,gastric, hepatobiliary,endometrial,melanoma,ovarian,cervical,salivary gland,pancreatic,breast

Phase

Phase 2

Healthy volunteers

No

Study drug

Trastuzumab deruxtecan

Sex

All

Actual Enrollment

102

Study type

Interventional

Age

18 Years - 120 Years

Date

Study Start Date: 30 Dec 2020
Primary Completion Date: 25 Jan 2023
Estimated Study Completion Date: 14 Jul 2026

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo Co., Ltd.

Inclusion and exclusion criteria