Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NCT05609370 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18+Age Over 18

Bowel<br/>CancersCancer LocationBowel
Cancers

Systemic therapy,Treatment | Bowel (colorectum)Colorectum

Trial Overview Read MoreRead more

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 cancer.
 

This trial is treating patients with microsatellite stable/mismatch repair proficient colorectal cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

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

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

Commercial Sponsor

BeiGene Australia Pty Ltd

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.

Recruiting Hospitals Read MoreRead more

Border Medical Oncology
Albury
Ms Kate Oates
koates@bordermedonc.com.au
02 6064 1499

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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