A Phase 1/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
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.
Arms & interventions
- DrugCR-001
Intravenous Infusion
Outcome measures
Primary
Dose Escalation - Incidence and nature of dose-limiting toxicities
Per cohort
Time frame: From the first dose of study drug up until approximately 1 month
Dose Escalation - Characterization of the maximum tolerated dose, if applicable
Per Cohort
Time frame: From the first dose of study drug up until approximately 1 month
All parts - Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and treatment - emergent serious adverse events
Events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Time frame: From the first dose of study drug until 90 days after the last dose of study drug
All parts - Incidence and severity of TEAEs leading to dose modifications
Time frame: From the first dose of study drug until 90 days after the last dose of study drug
All parts - Incidence and severity of TEAEs leading to treatment discontinuation
Time frame: From the first dose of study drug until 90 days after the last dose of study drug
Secondary
All parts - Determination of recommended Phase 2 dose(s)
Time frame: From the first dose of study drug until 90 days after the last dose of study drug
All parts - Serum CR-001 pharmacokinetic parameters
Time frame: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
Time frame: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
Time frame: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
Time frame: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
Time frame: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
Time frame: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
Time frame: Predose until up to approximately 36 months
All parts - Incidence of participants with detectable antidrug antibodies
Time frame: Predose until up to approximately 36 months
All parts - Overall response rate
Time frame: From the first dose of study drug until up to approximately 36 months
All parts - Duration of response
Time frame: From the first dose of study drug until up to approximately 36 months
All parts - Time to response
Time frame: From the first dose of study drug until up to approximately 36 months
All parts - Progression free survival
Time frame: From the first dose of study drug until up to approximately 36 months
All parts - Overall survival
Time frame: From the first dose of study drug until up to approximately 36 months
All parts - Best percent change in target lesions
Time frame: From the first dose of study drug until up to approximately 36 months
Eligibility criteria
Study locations (12)
Clinical Study Site
Los Angeles, California, 90033
Clinical Study Site
Denver, Colorado, 80218
Clinical Study Site
Orlando, Florida, 32827
Clinical Study Site
Sarasota, Florida, 34236
Clinical Study Site
Detroit, Michigan, 48201
Clinical Study Site
Grand Rapids, Michigan, 49546
Clinical Study Site
New York, New York, 10029
Clinical Study Site
Columbus, Ohio, 43210
Clinical Study Site
Nashville, Tennessee, 37203
Clinical Study Site
Dallas, Texas, 75230
Clinical Study Site
San Antonio, Texas, 78229
Clinical Study Site
West Valley City, Utah, 84119