Trial purpose
Cancer treatment
Tumor type
Lower gastrointestinal tract
Age
18+
Clinical summary
Summary
This study has two phases.
In Phase 1b, participants will receive LBL-007 + tislelizumab + bevacizumab + capecitabine in a modified 3+3 scheme that will evaluate LBL-007 in 2 dose levels.
In the second phase, there are five experimental arms and eligible participants will be randomly allocated.
- Experimental Arm A will recruit Protein Ligand -1 (PD-L1) Positive participants, and they will receive LBL-007 + tislelizumab + bevacizumab + capecitabine.
- Experimental Arm B will recruit PD-L1 Positive participants, who will receive LBL-007 + bevacizumab + capecitabine.
- Experimental Arm C will recruit PD-L1 Positive participants, who will receive bevacizumab + capecitabine.
- Experimental Arm D will recruit PD-L1 Negative participants, who will receive LBL-007 + tislelizumab + bevacizumab + capecitabine.
- Experimental Arm E will recruit PD-L1 Negative participants, who will receive bevacizumab + capecitabine.
LBL-007 will be administered once every 3 weeks intravenously. Tislelizumab will be administered at a dose of 300mg intravenously once every 3 weeks. Bevacizumab will be administered at a dose of 7.5mg/kg intravenously once every 3 weeks. Capecitabine will be administered at a dose of 1000mg/m^2 twice daily orally on days 1 to 14 of each 21-day treatment cycle.
Conditions
This trial is treating people with microsatellite stable/mismatch repair proficient colorectal cancer
Eligibility
Inclusion
- 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
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
BeiGene Australia Pty Ltd
Scientific Title
A Phase 1b/2, Randomized, Open-Label Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Capecitabine Versus Bevacizumab Plus Capecitabine as Maintenance Therapy in Patients With Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer
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