Clinical Trial

A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors

Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \[cutaneous/acral\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2023-12-07; most recent amendment 2026-05-12.
Status change: Not Yet Recruiting → Recruiting 2024-03-11
Trial Details
NCT Number NCT06172478
Lead Sponsor Daiichi Sankyo
Collaborators: Merck Sharp & Dohme LLC
Conditions Advanced Solid Tumor, Melanoma, Head and Neck Cancer, Gastric Cancer, Ovarian Carcinoma, Cervical Cancer, Endometrial Cancer, Bladder Cancer +6 more
Enrollment 740 participants
Start Date 2024-02-26
Primary Completion 2027-09-01 (estimated)
Study Completion 2028-10-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-10