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, and LBL-007 in combination with bevacizumab plus fluoropyrimidine versus 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 or 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. 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

You CAN'T join if...

  • 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.

Locations

  • UCLA
    Los Angeles California 90095 United States
  • Valkyrie Clinical Trials
    Los Angeles California 90067 United States
  • Usc Norris Comprehensive Cancer Center (Nccc)
    Los Angeles California 90033 United States
  • Toi Clinical Research
    Cerritos California 90703 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BeiGene
ID
NCT05609370
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
About 113 people participating
Last Updated