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

Prostate Cancer Clinical Trial

Official title:
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

Clinical Trial Summary

This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma [cutaneous/acral], squamous cell carcinomas of the head and neck (SCCHN), and HER2-negative gastric cancer, ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, and prostate cancer.

Clinical Trial Description

This study is designed to assess the safety and efficacy of HER3-DXd monotherapy in subjects with refractory locally advanced 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 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 or metastatic tumor. HER3 protein expression in tumor tissue and its relationship with HER3-DXd efficacy will also be evaluated. ;

Study Design

Related Conditions & MeSH terms

  • Advanced Solid Tumor
  • Bladder Cancer
  • Carcinoma
  • Carcinoma, Ovarian Epithelial
  • Cervical Cancer
  • Endometrial Cancer
  • Endometrial Neoplasms
  • Esophageal Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • Melanoma
  • Ovarian Carcinoma
  • Ovarian Neoplasms
  • Pancreatic Carcinoma
  • Pancreatic Neoplasms
  • Prostate Cancer
  • Prostatic Neoplasms
  • Stomach Neoplasms
  • Urinary Bladder Neoplasms
  • Uterine Cervical Neoplasms
Clinical Trial Details
NCT number NCT06172478
Study type Interventional
Source Daiichi Sankyo
Contact Daiichi Sankyo Contact for Clinical Trial Information
Phone 9089926400
Email CTRinfo@dsi.com
Status Recruiting
Phase Phase 2
Start date February 26, 2024
Completion date April 30, 2026
View Details
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