LBL-007+ Tislelizumab w/Bevacizumab vs. Bevacizumab and capecitabine in CRC (Colorectal Cancer)

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:<ul>
<li>Unresectable colorectal cancer (cannot be surgically removed)</li>
<li>Metastatic colorectal carcinoma (cancer that has spread to other areas outside the colon)</li></ul>
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:<ul>
<li>Be assigned to either phase 1b or phase 2</li>
<li>Receive the study drugs, LBL-007, tislelizumab, and bevacizumab, through an IV and capecitabine orally once every 3 weeks if assigned to phase 1b</li>
<li>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</li>
<li>Have a tumor biopsy done, if necessary</li>
<li>Have blood draws</li>
<li>Have imaging scans (CT or MRI)</li></ul>

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

John
Strickler

Protocol Number

PRO00112102

NCT ID

NCT05609370

Phase

I/II

Enrollment Status

Open to Enrollment