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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
290
Intravenous Infusion
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
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
AUC0--inf after a single dose and steady state parameters, as appropriate
Time frame: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinical Study Site
Birmingham, Alabama, United States
RECRUITINGClinical Study Site
Los Angeles, California, United States
RECRUITINGClinical Study Site
Denver, Colorado, United States
RECRUITINGClinical Study Site
Washington D.C., District of Columbia, United States
RECRUITINGClinical Study Site
Orlando, Florida, United States
RECRUITINGClinical Study Site
Sarasota, Florida, United States
RECRUITINGClinical Study Site
Detroit, Michigan, United States
RECRUITINGClinical Study Site
Grand Rapids, Michigan, United States
RECRUITINGClinical Study Site
New York, New York, United States
RECRUITINGClinical Study Site
Columbus, Ohio, United States
RECRUITING...and 21 more locations
AUClast after a single dose and steady state parameters, as appropriate
Time frame: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
Cmax after a single dose and steady state parameters, as appropriate
Time frame: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
Tmax after a single dose and steady state parameters, as appropriate
Time frame: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
Vd after a single dose and steady state parameters, as appropriate
Time frame: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
CL after a single dose and steady state parameters, as appropriate
Time frame: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
t½ after a single dose and steady state parameters, as appropriate
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