A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer
Purpose
This is a Phase 1b/2 study to investigate the efficacy and safety of LBL-007 plus Tislelizumab when administered in combination with bevacizumab plus fluoropyrimidine to participants with colorectal cancer.
Condition
- Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participant must have measurable disease as defined per RECIST version 1.1 - Has a histologically confirmed colorectal adenocarcinoma with metastatic or unresectable disease (Stage IV as defined by American Joint Committee on Cancer [AJCC] 8th edition) - No prior systemic therapy for colorectal cancer (CRC) in the metastatic setting except for the induction treatment of first-line therapy. Note: Local regional treatment performed during induction systemic treatment is allowed - Participants who have completed the first-line induction treatment, with an overall response of stable disease or better
Exclusion Criteria
- Participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible - Induction treatment initiated less than 6 months from completion of any prior neoadjuvant or adjuvant chemotherapy or radiotherapy which occurred later - Participants who have been treated with anti-epidermal growth factor receptor (EGFR) antibody in the induction treatment - Any prior therapy targeting T-cell stimulation or checkpoint pathways - Participants with B-raf proto-oncogene, serine/threonine kinase (BRAF)V600E mutations - Have locally or centrally confirmed microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR) method or dMMR by immunohistochemistry (IHC) method Note: Other protocol defined criteria may apply.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Phase 1b: Cohort-1: LBL-007 + tislelizumab + bevacizumab + capecitabine |
LBL-007 + tislelizumab + bevacizumab + capecitabine |
|
Experimental Phase 1b: Cohort 1a: LBL-007 + tislelizumab + bevacizumab + capecitabine |
LBL-007 + tislelizumab + bevacizumab + capecitabine |
|
Experimental Phase 1b: Cohort 2: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine |
LBL-007 + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 2 weeks or 5 mg/kg once every 3 weeks)+ fluoropyrimidine (5-FU or capecitabine) |
|
Experimental Phase 2: Arm A and Arm D: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine |
LBL-007 + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine) |
|
Experimental Phase 2: Arm B: LBL-007 + bevacizumab + fluoropyrimidine |
LBL-007 + bevacizumab (7.5 mg/kgonce every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine) |
|
Other Phase 2: Arm C and Arm E: bevacizumab + fluoropyrimidine |
bevacizumab (7.5 mg/kg once every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine) |
|
Experimental Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil (5-FU) |
LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil |
|
Recruiting Locations
Ut Health San Antonio Mays Cancer Center
San Antonio, Texas 78229
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- BeiGene