Status:
RECRUITING
A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors
Lead Sponsor:
Corbus Pharmaceuticals Inc.
Collaborating Sponsors:
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Conditions:
Solid Tumor, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4. The main questions it aims to answe...
Detailed Description
This is a three-part open-label, Phase 1/2 clinical trial designed to evaluate the safety, PK, and efficacy of CRB-701 in participants with advanced solid tumors expressing nectin-4. Part A will incl...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid tumors that have progressed having exhausted all appropriate lines of therapy or have no other standard therapy with proven clinical benefit. In Part C, HNSCC participants may enroll as first-line therapy.
Exclusion
- Active of uncontrolled CNS metastases
- History of solid tumors other than the diseases under study
- History of and/or current cardiovascular events or conditions in the previous 6 months
- Pre-existing \>/= Grade 2 neuropathy
- Hemoglobin A1C (HbA1C) \>/= 8%, uncontrolled diabetes mellitus or know diabetic neuropathy
- Active ocular disease at baseline
- Chronic severe liver disease or live cirrhosis
- Interstitial lung disease or pneumonitis within 6 months on initiating treatment on study
- Other significant cormorbidities.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 27 2027
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT06265727
Start Date
April 1 2024
End Date
January 27 2027
Last Update
January 8 2026
Active Locations (41)
Enter a location and click search to find clinical trials sorted by distance.
1
O'Neal Comprehensive Cancer Center at University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
2
City of Hope Cancer Center
Duarte, California, United States, 91010
3
Moores Cancer Centre at UC San Diego Health
San Diego, California, United States, 92037
4
Helen Diller Family Comprehensive Cancer Center - UCSF
San Francisco, California, United States, 94115