LBL-007+ Tislelizumab w/Bevacizumab vs. Bevacizumab and capecitabine in CRC (Colorectal Cancer) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to see if the study drugs, LBL-007 plus tislelizumab in combination with bevacizumab plus capecitabine, are safe and effective for treating metastatic or unresectable colorectal cancer.
What is the Condition Being Studied?
Colorectal Carcinoma
Who Can Participate in the Study?
Adults with one of the following types of cancer:
- Unresectable colorectal cancer (cannot be surgically removed)
- Metastatic colorectal carcinoma (cancer that has spread to other areas outside the colon)
The cancer must not be treatable with surgery alone.
For more information about who can join this study, please contact the study team at gi-oncology-cru@dm.duke.edu or 919-668-1861.
Age Group
Adults
What is Involved?
If you choose to join this study, you will:
- Be assigned to either phase 1b or phase 2
- Receive the study drugs, LBL-007, tislelizumab, and bevacizumab, through an IV and capecitabine orally once every 3 weeks if assigned to phase 1b
- Receive the study drugs, LBL-007 with or without tislelizumab, and bevacizumab, through an IV and capecitabine orally once every 3 weeks if assigned to phase 2
- Have a tumor biopsy done, if necessary
- Have blood draws
- Have imaging scans (CT or MRI)
Study Details
Full Title
A Phase 1b/2, Randomized, Open-Label Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine as Maintenance Therapy in Patients With Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient
Colorectal Cancer
Principal Investigator
Medical Oncologist
Protocol Number
IRB:
PRO00112102
NCT:
NCT05609370
Phase
Phase
I/II
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment