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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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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Participant must have measurable disease as defined per RECIST version 1.1
  2. Has a histologically confirmed colorectal adenocarcinoma with metastatic or unresectable disease (Stage IV as defined by American Joint Committee on Cancer [AJCC] 8th edition)
  3. 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
  4. Participants who have completed the first-line induction treatment, with an overall response of stable disease or better

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible
  2. Induction treatment initiated less than 6 months from completion of any prior neoadjuvant or adjuvant chemotherapy or radiotherapy which occurred later
  3. Participants who have been treated with anti-epidermal growth factor receptor (EGFR) antibody in the induction treatment
  4. Any prior therapy targeting T-cell stimulation or checkpoint pathways
  5. Participants with B-raf proto-oncogene, serine/threonine kinase (BRAF)V600E mutations
  6. 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.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-828-5568Email iconEmail Study Center

Study Details


Contition

Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer

Age

18+

Phase

PHASE1/PHASE2

Participants Needed

226

Est. Completion Date

Apr 30, 2028

Treatment Type

INTERVENTIONAL


Sponsor

BeiGene

ClinicalTrials.gov NCT Identifier

NCT05609370

Study Number

BGB-A317-LBL-007-201

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