Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors
Start Date
4/30/2021
Completion Date
6/1/2028
Summary
The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.
Detailed Description
Phase 1/1b, multi-center, open-label, dose-escalation study to: * Evaluate the safety profile and MTD of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 when administered orally to establish the recommended Phase 2 dose and schedule * Characterize the PK and pharmacodynamics of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 * Assess preliminary anti-tumor activity associated with lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 This study was previously posted by Repare Therapeutics. In September 2025, sponsorship of the trial was transferred to Debiopharm International S.A Expanded Access Status: There is no expanded access program available for the investigational products in this study at this time.
Eligibility Criteria
Age Range: 12 years to No maximum
Interventions
Lunresertib
RP-3500
Debio0123
Conditions
Locations
# 1019, UCLA, Westwood Cancer Center
Los Angeles, California 90095
United States
#1025, University of California San Francisco
San Francisco, California 94158
United States
#1012, Yale
New Haven, Connecticut 06520
United States
#1017, Mayo Clinic
Jacksonville, Florida 32224
United States
#1002, Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
#1023, START Midwest
Grand Rapids, Michigan 49503
United States
#1016, Mayo Clinic
Rochester, Minnesota 55902
United States
#1011, Washington University
St Louis, Missouri 63130
United States
#1032, Northwell Health Cancer Institute
New Hyde Park, New York 11042
United States
#1008, Columbia University
New York, New York 10032
United States
#1004, Memorial Sloan Kettering Cancer Institute
New York, New York 10065
United States
#1010, University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
#1007, Rhode Island Hospital
Providence, Rhode Island 02903
United States
#1030, Women & Infants Hospital of Rhode Island
Providence, Rhode Island 02903
United States
#1001, The University of Texas M.D. Anderson Cancer Center
Houston, Texas 77030
United States
#1013, The University of Utah
Salt Lake City, Utah 84112
United States
#1027, University of Virginia
Charlottesville, Virginia 22903
United States
#2002, The Hospital for Sick Children
Toronto, Ontario M5G 1X8
Canada
#2001, Princess Margaret Cancer Centre
Toronto, Ontario M5G 2C1
Canada
#2003, The Research Institute of the McGill University Health Centre
Montreal, Quebec H4A 3J1
Canada
#4001, Rigshospitalet - Blegdamsvej
Copenhagen,
Denmark
#3003, Sarah Cannon Research Institute
London, W1G 6AD
United Kingdom