RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-02-26
Study Completion:2028-10-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06172478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
9089926400
CTRinfo@dsi.com

Principal Investigator

Global Clinical Leader
STUDY_DIRECTOR
Daiichi Sankyo

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
Yale Cancer Center
New Haven, Connecticut, 06510
United States
AdventHealth Medical Group Oncology Research at Celebration
Kissimmee, Florida, 34747
United States
University of Illinois Cancer Center
Chicago, Illinois, 60612
United States
Johns Hopkins University
Baltimore, Maryland, 21205
United States
Health Partners Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426
United States
Health Partners Cancer Center at Regions Hospital
Saint Paul, Minnesota, 55101
United States
Washington University, School of Medicine
Saint Louis, Missouri, 63110
United States
Roswell Park Cancer Institute IDS
Buffalo, New York, 14203
United States
Memorial Sloan Kettering Hospital
New York, New York, 10065
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Daiichi Sankyo

  • Global Clinical Leader, STUDY_DIRECTOR, Daiichi Sankyo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-26
Study Completion Date2028-10-10

Study Record Updates

Study Start Date2024-02-26
Study Completion Date2028-10-10

Terms related to this study

Keywords Provided by Researchers

  • Advanced Solid Tumor
  • Melanoma
  • Head and Neck Cancer
  • Gastric Cancer
  • Ovarian carcinoma
  • Cervical cancer
  • Endometrial cancer
  • Bladder cancer
  • Esophageal carcinoma
  • Pancreatic carcinoma
  • Prostate cancer
  • Patritumab Deruxtecan
  • HER3-DXd
  • U3-1402
  • Lung Cancer
  • Breast Cancer

Additional Relevant MeSH Terms

  • 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