NCT06172478

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 740 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed to assess the safety and efficacy of HER3-DXd monotherapy in subjects with refractory locally advanced unresectable or metastatic solid tumors who have been previously treated with ≥1 prior line of systemic anticancer therapy. The primary objective of the study is to assess the efficacy of HER3-DXd monotherapy for each type of indicated locally advanced unresectable or metastatic tumor. Secondary objectives include the assessment of safety and tolerability, efficacy, and pharmacokinetics of HER3-DXd monotherapy for each type of indicated locally advanced unresectable or metastatic tumor. HER3 protein expression in tumor tissue and its relationship with HER3-DXd efficacy will also be evaluated.

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

Type	Name	Description
DRUG	HER3-DXd	Intravenous infusion 5.6 mg/kg administered Q3W on Day 1 of each 21-day cycle

Timeline

• Start date: 2024-02-26
• Primary completion: 2027-09-01
• Completion: 2028-10-10
• First posted: 2023-12-15
• Last updated: 2026-01-28

Locations

84 sites across 16 countries: United States, Australia, Belgium, Canada, China, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study