Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

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.

Official 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

Keywords

Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer, Colorectal Cancer, Microsatellite Stable, Mismatch Repair Proficient, Maintenance Therapy, Colorectal Neoplasms, Bevacizumab, Tislelizumab, Capecitabine, Fluorouracil, LBL-007, Bevacizumab biosimilar, 5-Fluorouracil

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • Usc Norris Comprehensive Cancer Center (Nccc) accepting new patients
    Los Angeles California 90033 United States
  • Toi Clinical Research accepting new patients
    Cerritos California 90703 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BeiGene
Links
Sign up for this study
ID
NCT05609370
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 226 study participants
Last Updated