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.
Who Can Participate?
Eligibility
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.
- 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.
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)
- 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
Colorectal Cancer
Principal Investigator
John
Strickler
Protocol Number
PRO00112102
NCT ID
NCT05609370
Phase
I/II
Enrollment Status
OPEN TO ACCRUAL