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, and LBL-007 in combination with bevacizumab plus fluoropyrimidine versus 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. The duration of induction treatment should be completed within approximately 6 months. The first dose of study treatment needs to occur within 2 weeks (for 2-week regimen) or 3 weeks (for 3-week regimen) to 6 weeks after Day 1 of the last cycle of induction therapy

Exclusion Criteria

Participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible - Progressive disease occurred less than 6 months from completion of any prior neoadjuvant therapy (ie, chemotherapy with or without radiotherapy) or adjuvant therapy (ie, chemotherapy with or without radiotherapy), whichever 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 (low dose) + tislelizumab (low dose once every 3 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks) + capecitabine	Drug: LBL-007 Administered intravenously. Drug: Tislelizumab Administered intravenously. Other names: BGB-A317 Drug: Bevacizumab or Bevacizumab biosimilar Administered intravenously Drug: Capecitabine Administered in accordance with relevant local guidelines and/or prescribing information
Experimental Phase 1b: Cohort 1a: LBL-007 + Tislelizumab + Bevacizumab + Capecitabine	LBL-007 (medium dose) + tislelizumab (low dose once every 3 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks) + capecitabine	Drug: LBL-007 Administered intravenously. Drug: Tislelizumab Administered intravenously. Other names: BGB-A317 Drug: Bevacizumab or Bevacizumab biosimilar Administered intravenously Drug: Capecitabine Administered in accordance with relevant local guidelines and/or prescribing information
Experimental Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5-Fluorouracil (5-FU)	LBL-007 (medium dose) + tislelizumab (high dose once every 4 weeks) + bevacizumab (5 mg/kg once every 2 weeks) + 5-FU	Drug: LBL-007 Administered intravenously. Drug: Tislelizumab Administered intravenously. Other names: BGB-A317 Drug: Bevacizumab or Bevacizumab biosimilar Administered intravenously Drug: 5-Fluorouracil Administered in accordance with relevant local guidelines and/or prescribing information
Experimental Phase 1b: Cohort 2: LBL-007 + Tislelizumab + Bevacizumab + Fluoropyrimidine	LBL-007 (high dose) + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine)	Drug: LBL-007 Administered intravenously. Drug: Tislelizumab Administered intravenously. Other names: BGB-A317 Drug: Bevacizumab or Bevacizumab biosimilar Administered intravenously Drug: Capecitabine Administered in accordance with relevant local guidelines and/or prescribing information Drug: 5-Fluorouracil Administered in accordance with relevant local guidelines and/or prescribing information
Experimental Phase 2: Arm A and Arm D: LBL-007 + Tislelizumab + Bevacizumab + Fluoropyrimidine	LBL-007 (high dose) + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine)	Drug: LBL-007 Administered intravenously. Drug: Tislelizumab Administered intravenously. Other names: BGB-A317 Drug: Bevacizumab or Bevacizumab biosimilar Administered intravenously Drug: Capecitabine Administered in accordance with relevant local guidelines and/or prescribing information Drug: 5-Fluorouracil Administered in accordance with relevant local guidelines and/or prescribing information
Experimental Phase 2: Arm B: LBL-007 + Bevacizumab + Fluoropyrimidine	LBL-007 (high dose) + bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine)	Drug: LBL-007 Administered intravenously. Drug: Bevacizumab or Bevacizumab biosimilar Administered intravenously Drug: Capecitabine Administered in accordance with relevant local guidelines and/or prescribing information Drug: 5-Fluorouracil Administered in accordance with relevant local guidelines and/or prescribing information
Active Comparator Phase 2: Arm C and Arm E: Bevacizumab + Fluoropyrimidine	Bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine)	Drug: LBL-007 Administered intravenously. Drug: Tislelizumab Administered intravenously. Other names: BGB-A317 Drug: Bevacizumab or Bevacizumab biosimilar Administered intravenously Drug: Capecitabine Administered in accordance with relevant local guidelines and/or prescribing information Drug: 5-Fluorouracil Administered in accordance with relevant local guidelines and/or prescribing information

More Details

Status: Active, not recruiting
Sponsor: BeiGene

Study Contact

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.