Status:
RECRUITING
First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.
Lead Sponsor:
Corbus Pharmaceuticals Inc.
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the safety, blood concentrations and treatment effect of CRB-601 in combination with immunotherapy in patients who have advanced solid tumors (cancer) and hav...
Detailed Description
CRB-601-01 is a three-part interventional study which aims to: * To determine the maximum tolerated dose (MTD) and pharmacologically active dose range (PADR) for CRB-601 administered as a monotherapy...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of select locally advanced or metastatic solid tumors that have progressed after at least one line of therapy or have no other standard therapy with proven clinical benefit available.
- Measurable disease on imaging as assessed by RECIST 1.1 Eastern Cooperative Oncology Group (ECOG) performance status (PS) greater or equal to 2.
- Life expectancy of more than 12 weeks.
- Adequate hematologic and end-organ function.
Exclusion
- History of solid tumor malignancies other than the disease under study within 3 years of study enrollment
- History of and/or current cardiovascular events or conditions
- Chronic severe liver disease or liver cirrhosis
- Systemic autoimmune disease
- Active thrombophlebitis, thromboembolism or hypercoagulability states or uncontrolled bleeding or diabetes.
- Interstitial lung disease within 6 months of study enrollment.
- Active or persistent infection
- Other conditions that in the opinion of the Investigator would compromise the outcomes of the study.
Key Trial Info
Start Date :
December 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT06603844
Start Date
December 4 2024
End Date
December 1 2026
Last Update
June 3 2025
Active Locations (26)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
SCRI - Arizona Oncology Associates
Tucson, Arizona, United States, 85711
3
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
4
UC San Diego Health - Moores Cancer Center
La Jolla, California, United States, 92093