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NCT06172478 · ClinicalTrials.gov registry record · Phase 2
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
A Phase 2 study of Melanoma and Head and Neck Cancer, sponsored by Daiichi Sankyo.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 740
- Enrollment target
- 20
- Study locations
NCT06172478: Recruiting Phase 2 study of Melanoma and Head and Neck Cancer, sponsored by Daiichi Sankyo.
NCT06172478 is a Phase 2 study of Melanoma and Head and Neck Cancer that is actively recruiting participants, run by Daiichi Sankyo. The registered enrollment target is 740 participants, roughly in line with the 704-participant average among 266 other Melanoma trials with a reported enrollment target. The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06172478, a Phase 2 study of Melanoma and Head and Neck Cancer, is actively recruiting participants, sponsored by Daiichi Sankyo.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 740 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on investigator by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Conditions Studied
Interventions
- DRUG HER3-DXd
Study Locations (20)
Other
- Chris O'Brien Lifehouse - Camperdown
- Icon Cancer Centre Chermside - Chermside
- Monash Medical Centre Clayton - Clayton
- Icon Cancer Centre Hobart - Hobart
- Icon Cancer Centre Townsville - Hyde Park
- Cliniques Universitaires Saint-Luc - Brussels
- UZA - Edegem
Minnesota
- Health Partners Frauenshuh Cancer Center - Saint Louis Park
- Health Partners Cancer Center at Regions Hospital - Saint Paul
New York
- Roswell Park Cancer Institute IDS - Buffalo
- Memorial Sloan Kettering Hospital - New York
California
- City of Hope - Duarte
Connecticut
- Yale Cancer Center - New Haven
Florida
- AdventHealth Medical Group Oncology Research at Celebration - Kissimmee
Illinois
- University of Illinois Cancer Center - Chicago
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 740 participants |
| Start Date | 2024-02-26 |
| Est. Completion | 2028-10-10 |
| Phase | Phase 2 |
What NCT06172478 shows while recruiting
NCT06172478 is an interventional study that assigns participants to a tested intervention. The registered 740 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 704-participant average among 266 other Melanoma trials with a reported enrollment target.
The record links to 10 conditions, with Melanoma appearing as the primary indexed condition, and to 1 intervention - of which HER3-DXd is the first listed.
NCT06172478 names 20 study sites across 12 states, led by Other, Minnesota, New York.
Frequently Asked Questions
What is clinical trial NCT06172478 about?
NCT06172478 is a clinical study titled "A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors". 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 ca...
What is the current status of trial NCT06172478?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 740 participants. The study started on 2024-02-26. Estimated completion is 2028-10-10.
What conditions does trial NCT06172478 study?
This clinical trial studies the following conditions: Melanoma, Head and Neck Cancer, Advanced Solid Tumor, Endometrial Cancer, Bladder Cancer.
What interventions are being tested in trial NCT06172478?
The interventions under investigation include: HER3-DXd (DRUG).
Who is sponsoring clinical trial NCT06172478?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06172478 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06172478's enrollment target sits among peer trials
740 30th of 266 higher than 237 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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