Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles 5368361, California 5332921 and other locations
Dates
study started
study ends 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, tislelizumab, Bevacizumab, 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 5368361 California 5332921 90095 United States
  • Valkyrie Clinical Trials
    Los Angeles 5368361 California 5332921 90067 United States
  • Usc Norris Comprehensive Cancer Center (Nccc)
    Los Angeles 5368361 California 5332921 90033 United States
  • Toi Clinical Research
    Cerritos 5335663 California 5332921 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