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

NCT06172478 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 740

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

HER3-DXd

Intravenous infusion 5.6 mg/kg administered Q3W on Day 1 of each 21-day cycle

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-26
Primary Completion
2027-09-01
Completion
2028-10-10
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • Norway
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06172478 on ClinicalTrials.gov