CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 740 target
Drug / intervention
HER3-DXddrug
Likely dose
HER3-DXd 5.6 mg/kgfrom record
Key inclusion· 5
  • ✓Aged ≥18 years
  • ✓Locally advanced unresectable or metastatic disease not curable by surgery or radiation
  • ✓ECOG performance status 0 or 1 at screening
  • ✓≥1 measurable lesion on CT or MRI per RECIST v1.1
Key exclusion· 10
  • ✕HER2-positive gastric cancer
  • ✕Nasopharyngeal cancer
  • ✕Mucosal or uveal melanoma
  • ✕History of interstitial lung disease requiring corticosteroids or current ILD/pneumonitis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06172478
NCT06172478Phase 2RecruitingHigh Momentum
CompareCT.gov

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

Daiichi Sankyo·interventional·Posted Dec 15, 2023·Updated May 15, 2026

In Brief

A Phase 2 clinical trial evaluating HER3-DXd for Advanced Solid Tumor and 13 related conditions. Currently recruiting, targeting 740 participants across 85 sites in 16 countries.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced 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
CountriesAustralia, Belgium, Canada, China, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, South Korea, Spain, Taiwan, United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2Recruiting
20242025202620272028
First PostedDec 15, 2023
Enrollment StartFeb 26, 2024
Primary CompletionSep 1, 2027
Study CompletionOct 10, 2028
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 2.5 years agoPrimary completion in 1.2 years

Interventions

HER3-DXddrug

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