The trial is taking place at:
C

Cooper University HealthCare | MD Anderson Cancer Center at Cooper

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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

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Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer

Treatments

Drug: 5-Fluorouracil
Drug: Capecitabine
Drug: LBL-007
Drug: Tislelizumab
Drug: Bevacizumab biosimilar

Study type

Interventional

Funder types

Industry

Identifiers

NCT05609370
BGB-A317-LBL-007-201
CTR20223077 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

226 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

226 participants in 7 patient groups

Phase 1b: Cohort-1: LBL-007 + tislelizumab + bevacizumab + capecitabine
Experimental group
Description:
LBL-007 + tislelizumab + bevacizumab + capecitabine
Treatment:
Drug: Bevacizumab biosimilar
Drug: Tislelizumab
Drug: LBL-007
Drug: Capecitabine
Phase 1b: Cohort 1a: LBL-007 + tislelizumab + bevacizumab + capecitabine
Experimental group
Description:
LBL-007 + tislelizumab + bevacizumab + capecitabine
Treatment:
Drug: Bevacizumab biosimilar
Drug: Tislelizumab
Drug: LBL-007
Drug: Capecitabine
Phase 1b: Cohort 2: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Experimental group
Description:
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)
Treatment:
Drug: Bevacizumab biosimilar
Drug: Tislelizumab
Drug: LBL-007
Drug: Capecitabine
Drug: 5-Fluorouracil
Phase 2: Arm A and Arm D: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Experimental group
Description:
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)
Treatment:
Drug: Bevacizumab biosimilar
Drug: Tislelizumab
Drug: LBL-007
Drug: Capecitabine
Drug: 5-Fluorouracil
Phase 2: Arm B: LBL-007 + bevacizumab + fluoropyrimidine
Experimental group
Description:
LBL-007 + bevacizumab (7.5 mg/kgonce every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine)
Treatment:
Drug: Bevacizumab biosimilar
Drug: LBL-007
Drug: Capecitabine
Drug: 5-Fluorouracil
Phase 2: Arm C and Arm E: bevacizumab + fluoropyrimidine
Other group
Description:
bevacizumab (7.5 mg/kg once every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine)
Treatment:
Drug: Bevacizumab biosimilar
Drug: Capecitabine
Drug: 5-Fluorouracil
Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil (5-FU)
Experimental group
Description:
LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil
Treatment:
Drug: Bevacizumab biosimilar
Drug: Tislelizumab
Drug: LBL-007
Drug: 5-Fluorouracil

Trial contacts and locations

53

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Central trial contact

BeiGene

Data sourced from clinicaltrials.gov

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