A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
Start Date
1/4/2023
Completion Date
10/1/2026
Summary
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.
Detailed Description
This Phase 1/2 study consists of two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1 Dose Escalation, STAR0602 will be administered intravenously in participants with advanced solid tumors to assess safety/tolerability profile of STAR0602 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of STAR0602. In Phase 2 Dose Expansion, STAR0602 at RP2D will be administered to participants with advanced, antigen-rich solid tumors to further evaluate safety and assess preliminary clinical activity of STAR0602. Clinical activity will be evaluated by objective tumor response rate (ORR), duration of response (DOR), disease control rate (DCR), and progression free survival (PFS).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
STAR0602
Conditions
Locations
Loma Linda University Cancer Center
Loma Linda, California 92354
United States
UC Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado 80218
United States
AdventHealth Celebration
Celebration, Florida 34747
United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United States
The University of Kansas Cancer Center
Kansas City, Kansas 66160
United States
National Institutes of Health
Bethesda, Maryland 20892
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
University of Oklahoma Health Sciences, Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Sarah Cannon Research Institute Oncology Partners (SCRI-Nashville)
Nashville, Tennessee 37203
United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas 77030
United States
UT Health Mays Cancer Center
San Antonio, Texas 78229
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
University of Wisconsin- Madison
Madison, Wisconsin 53792
United States
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2C4
Canada
Research Institute of McGill University Health Centre
Montreal, Quebec H3H 2R9
Canada
Hopsital Institut Curie
Paris, France 75248
France
Oncopole Claudius Regaud IUCT
Toulouse, France 31100
France
Institut Bergonié
Bordeaux, 33076
France
Centre Leon Berard
Lyon, 69373
France
Institute Gustave Roussy
Villejuif, 94800
France
Vall d'Hebron Institute of Oncology
Barcelona, Catalonia 08035
Spain
Clinica Universidad de Navarra
San Blas-Canillejas, Madrid 28027
Spain
Hospital Universitario Quirónsalud Madrid
Madrid, Spain 28223
Spain
NEXT Oncology Barcelona, Hospital Quirónsalud Barcelona
Barcelona, 08023
Spain
START Madrid FJD
Madrid, 28040
Spain
Clinica Universidad de Navarra
Pamplona, 31008
Spain
Instituto de Investigacion Sanitaria, INCLIVA
Valencia, 46010
Spain