UT Health San Antonio

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	Drug: LBL-007 Low dose intravenously (IV) once every 3 weeks. Drug: Tislelizumab Low dose IV once every 3 weeks Other names: BGB-A-317 Drug: Bevacizumab biosimilar 7.5 mg/kg IV every 3 weeks Drug: Capecitabine 850 milligrams per square meter (mg/m^2) twice daily orally for 2 weeks, followed by a one-week treatment break every 3 weeks
Experimental Phase 1b: Cohort 1a: LBL-007 + tislelizumab + bevacizumab + capecitabine	LBL-007 + tislelizumab + bevacizumab + capecitabine	Drug: LBL-007 Medium dose IV once every 3 weeks Drug: Tislelizumab Low dose IV once every 3 weeks Other names: BGB-A-317 Drug: Bevacizumab biosimilar 7.5 mg/kg IV every 3 weeks Drug: Capecitabine 850 milligrams per square meter (mg/m^2) twice daily orally for 2 weeks, followed by a one-week treatment break every 3 weeks
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)	Drug: LBL-007 High dose IV once every 2 or 3 weeks Drug: Tislelizumab Low dose IV once every 3 weeks Other names: BGB-A-317 Drug: Tislelizumab High dose IV once every 4 weeks Other names: BGB-A-317 Drug: Bevacizumab biosimilar 7.5 mg/kg IV every 3 weeks Drug: Bevacizumab biosimilar 5 mg/kg IV once every 2 weeks Drug: Capecitabine 850 milligrams per square meter (mg/m^2) twice daily orally for 2 weeks, followed by a one-week treatment break every 3 weeks Drug: 5-Fluorouracil 1600 to 2400 mg/m^2 IV every 2 weeks
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)	Drug: LBL-007 High dose IV once every 2 or 3 weeks Drug: Tislelizumab Low dose IV once every 3 weeks Other names: BGB-A-317 Drug: Tislelizumab High dose IV once every 4 weeks Other names: BGB-A-317 Drug: Bevacizumab biosimilar 7.5 mg/kg IV every 3 weeks Drug: Bevacizumab biosimilar 5 mg/kg IV once every 2 weeks Drug: Capecitabine 850 milligrams per square meter (mg/m^2) twice daily orally for 2 weeks, followed by a one-week treatment break every 3 weeks Drug: 5-Fluorouracil 1600 to 2400 mg/m^2 IV every 2 weeks
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)	Drug: LBL-007 High dose IV once every 2 or 3 weeks Drug: Bevacizumab biosimilar 7.5 mg/kg IV every 3 weeks Drug: Bevacizumab biosimilar 5 mg/kg IV once every 2 weeks Drug: Capecitabine 850 milligrams per square meter (mg/m^2) twice daily orally for 2 weeks, followed by a one-week treatment break every 3 weeks Drug: 5-Fluorouracil 1600 to 2400 mg/m^2 IV every 2 weeks
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)	Drug: Bevacizumab biosimilar 7.5 mg/kg IV every 3 weeks Drug: Bevacizumab biosimilar 5 mg/kg IV once every 2 weeks Drug: Capecitabine 850 milligrams per square meter (mg/m^2) twice daily orally for 2 weeks, followed by a one-week treatment break every 3 weeks Drug: 5-Fluorouracil 1600 to 2400 mg/m^2 IV every 2 weeks
Experimental Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil (5-FU)	LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil	Drug: LBL-007 Medium dose IV once every 3 weeks Drug: Tislelizumab High dose IV once every 4 weeks Other names: BGB-A-317 Drug: Bevacizumab biosimilar 5 mg/kg IV once every 2 weeks Drug: 5-Fluorouracil 1600 to 2400 mg/m^2 IV every 2 weeks

Recruiting Locations

Ut Health San Antonio Mays Cancer Center
San Antonio, Texas 78229

More Details

Status: Recruiting
Sponsor: BeiGene

Study Contact

BeiGene
1-877-828-5568
clinicaltrials@beigene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.