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

Part of paid clinical trials in Duarte, California.

Sponsor
Daiichi Sankyo
Study ID
NCT06172478
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 26, 2024
Status verified
May 2026
Primary completion
Sep 1, 2027
Completion
Oct 10, 2028

Study Design

Enrollment
740 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HER3-DXd Monotherapy
    Participants with locally advanced unresectable or metastatic cancer (melanoma, head and neck, 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) will receive an intravenous infusion of HER3-DXd monotherapy 5.6 mg/kg every 3 weeks (Q3W).

Primary Outcome Measure

Number of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) [ Time Frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Yale Cancer CenterNew HavenConnecticut06510-
AdventHealth Medical Group Oncology Research at CelebrationKissimmeeFlorida34747-
University of Illinois Cancer CenterChicagoIllinois60612-
Johns Hopkins UniversityBaltimoreMaryland21205-
Health Partners Frauenshuh Cancer CenterSaint Louis ParkMinnesota55426-
Health Partners Cancer Center at Regions HospitalSaint PaulMinnesota55101-
Washington University, School of MedicineSt LouisMissouri63110-
Roswell Park Cancer Institute IDSBuffaloNew York14203-
Memorial Sloan Kettering HospitalNew YorkNew York10065-
SCRI Oncology PartnersNashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Fred Hutchinson Cancer CenterSeattleWashington98109-

Find similar trials in Duarte, CA

By condition
Bladder cancerBreast cancerCervical cancerEndometrial cancerEsophageal cancerGastric cancerHead and neck cancerLung cancerMelanomaOvarian cancerPancreatic cancerProstate cancer
By specialty
OncologyUrologyBreast oncologyWomen's healthGynecologic oncologyGI oncologyENTLung oncologyLung diseaseSkin cancerDermatologyProstate oncologyMen's health
By research site
City of Hope· Duarte, CAYale Cancer Center· New Haven, CTAdventHealth Medical Group Oncology Research at Celebration· Kissimmee, FLUniversity of Illinois Cancer Center· Chicago, ILJohns Hopkins University· Baltimore, MDHealth Partners Frauenshuh Cancer Center· Saint Louis Park, MN

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