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Head and Neck Cancer / Melanoma / HER3-DXd · Phase 2 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 proof-of-concept study registration for HER3-DXd monotherapy across 14 cancer types, currently recruiting. No efficacy or safety results are reported in this registry record; the trial is designed to assess objective response rate and PSA response as primary outcomes over approximately 27 months of follow-up.
Phase 2, Interventional, Single Group, Open label, Treatment purpose. Advanced Solid Tumor, Melanoma, Head and Neck Cancer, Gastric Cancer, Ovarian Carcinoma, Cervical Cancer, Endometrial Cancer, Bladder Cancer, Esophageal Cancer…; age from 18 Years. Intervention: HER3-DXd Monotherapy. n = 740. 85 sites across 16 countries.
This is a Phase 2 proof-of-concept study registration for HER3-DXd monotherapy across 14 cancer types, currently recruiting. No efficacy or safety results are reported in this registry record; the trial is designed to assess objective response rate and PSA response as primary outcomes over approximately 27 months of follow-up.
This is a trial registration; no efficacy, safety, or outcome data are reported.
The source did not state who this applies to in practice.
This is a Phase 2 proof-of-concept study registration with no results reported; the trial is actively recruiting and designed to explore HER3-DXd monotherapy across multiple solid tumor types.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06172478). This is a study registration, not published results. Lead sponsor: Daiichi Sankyo. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 740 participants (ESTIMATED). Conditions: Advanced Solid Tumor, Melanoma, Head and Neck Cancer, Gastric Cancer, Ovarian Carcinoma, Cervical Cancer, Endometrial Cancer, Bladder Cancer, Esophageal Cancer, Pancreatic Carcinoma, Prostate Cancer, Non-small Cell Lung Cancer (NSCLC), Lung Cancer, Breast Cancer. Interventions: DRUG: HER3-DXd. Primary outcome measures: Number of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) , Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months; Proportion of Participants Achieving a ≥50% Decrease in PSA (Prostate Cancer Cohort Only) , Baseline, each cycle before infusion (each cycle is 21 days), and end of treatment, up to approximately 27 months. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.