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RecruitingLast updated: 28 February 2024

LIBERTY-201: This phase I/II study is investigating how safe and effective LBL-007 plus Tislelizumab is when given in combination with targeted therapy (bevacizumab) and chemotherapy (capecitabine), compared to bevacizumab + capecitabine alone, in people with bowel cancerA 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

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 patients with microsatellite stable/mismatch repair proficient colorectal cancer

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

I/II

Trial Acronym

LIBERTY-201

More information

Trial Identifiers

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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

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 not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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