CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Start Date
2/17/2026
Completion Date
2/1/2029
Summary
The purpose of this study is to determine the safety and tolerability of monotherapy CR-001 and identify the maximum tolerated dose (MTD), and/or optimal biologic dose and Recommended Phase 2 Dose(s) (RP2D) in participants with locally advanced or metastatic solid tumors.
Detailed Description
The study will initially comprise 3 parts: dose escalation, backfill, and dose optimization cohorts. The study will follow a stepwise approach, beginning with a typical dose escalation in participants with selected indications of advanced solid tumors. Additional participants will enroll in the backfill part at select dose levels that have been previously cleared for safety by the safety review committee. In dose optimization, participants will be randomized to one of two CR-001 dose levels. All participants will undergo a screening period, a treatment period of up to 2 years, a safety follow-up period, and long-term efficacy and survival follow-up. During the treatment period, participants will undergo clinical and safety assessments including disease assessment scans and blood laboratory safety, pharmacokinetic, and pharmacodynamic assessments. After treatment ends, disease scans will continue until disease progression, and long-term follow-up visits will be conducted by telephone every 3 months.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
CR-001
Conditions
Locations
Clinical Study Site
Birmingham, Alabama 35294
United States
Clinical Study Site
Los Angeles, California 90033
United States
Clinical Study Site
Denver, Colorado 80218
United States
Clinical Study Site
Orlando, Florida 32827
United States
Clinical Study Site
Sarasota, Florida 34236
United States
Clinical Study Site
Detroit, Michigan 48201
United States
Clinical Study Site
Grand Rapids, Michigan 49546
United States
Clinical Study Site
New York, New York 10029
United States
Clinical Study Site
Columbus, Ohio 43210
United States
Clinical Study Site
Pittsburgh, Pennsylvania 15232
United States
Clinical Study Site
Nashville, Tennessee 37203
United States
Clinical Study Site
Dallas, Texas 75230
United States
Clinical Study Site
San Antonio, Texas 78229
United States
Clinical Study Site
West Valley City, Utah 84119
United States
Clinical Study Site
South Brisbane, Queensland 4101
Australia
Clinical Study Site
Dublin, Ireland
Ireland
Clinical Study Site
Milan, Milano 20089
Italy
Clinical Study Site
Cluj-Napoca, Cluj 400015
Romania
Clinical Study Site
Bucharest, 022328
Romania
Clinical Study Site
Seoul, Seoul 03080
South Korea
Clinical Study Site
Seoul, Seoul 03722
South Korea
Clinical Study Site
Seoul, Seoul 06351
South Korea
Clinical Study Site
Seongnam-si, 13620
South Korea
Clinical Study Site
Barcelona, Barcelona 08023
Spain
Clinical Study Site
Logroño, La Rioja 26006
Spain
Clinical Study Site
Madrid, Madrid 28040
Spain