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Monoclonal Antibodies

Combo Therapy for Colorectal Cancer

Phase 1 & 2
Recruiting
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 44 months
Awards & highlights

Summary

This trial studies a combo therapy for colorectal cancer, to see if it's safe and effective.

Who is the study for?
This trial is for adults with colorectal cancer that's spread or can't be surgically removed. They should have had some initial treatment and their disease must not have worsened. No prior treatments in the metastatic setting are allowed, except first-line therapy, and they shouldn't have certain genetic mutations or immune system conditions.
What is being tested?
The study tests LBL-007 plus Tislelizumab combined with Bevacizumab and a fluoropyrimidine (like 5-Fluorouracil or Capecitabine) against just Bevacizumab with a fluoropyrimidine. It aims to see if adding LBL-007 and Tislelizumab improves treatment outcomes.
What are the potential side effects?
Possible side effects include allergic reactions to medication components, increased risk of infection due to immune system suppression, bleeding from Bevacizumab use, skin issues, fatigue, digestive problems like diarrhea or mouth sores from chemotherapy drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 44 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 44 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1b: Number of participants with Adverse events (AE) and Serious AEs (SAE)
Upper arm
Secondary study objectives
Phase 2 : Number of participants with Adverse events (AE) and Serious AEs (SAE)
Upper arm
Upper arm
+8 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Phase 2: Arm C and Arm E: bevacizumab + fluoropyrimidineExperimental Treatment3 Interventions
bevacizumab (7.5 mg/kg once every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine)
Group II: Phase 2: Arm B: LBL-007 + bevacizumab + fluoropyrimidineExperimental Treatment4 Interventions
LBL-007 + bevacizumab (7.5 mg/kgonce every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine)
Group III: Phase 2: Arm A and Arm D: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidineExperimental Treatment5 Interventions
LBL-007 + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine)
Group IV: Phase 1b: Cohort-1: LBL-007 + tislelizumab + bevacizumab + capecitabineExperimental Treatment4 Interventions
LBL-007 + tislelizumab + bevacizumab + capecitabine
Group V: Phase 1b: Cohort 2: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidineExperimental Treatment5 Interventions
LBL-007 + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 2 weeks or 5 mg/kg once every 3 weeks)+ fluoropyrimidine (5-FU or capecitabine)
Group VI: Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil (5-FU)Experimental Treatment4 Interventions
LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil
Group VII: Phase 1b: Cohort 1a: LBL-007 + tislelizumab + bevacizumab + capecitabineExperimental Treatment4 Interventions
LBL-007 + tislelizumab + bevacizumab + capecitabine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3970
5-Fluorouracil
2012
Completed Phase 3
~7800
Tislelizumab
2018
Completed Phase 3
~4730

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
192 Previous Clinical Trials
30,062 Total Patients Enrolled

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05609370 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Phase 1b: Cohort 2: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine, Phase 1b: Cohort-1: LBL-007 + tislelizumab + bevacizumab + capecitabine, Phase 1b: Cohort 1a: LBL-007 + tislelizumab + bevacizumab + capecitabine, Phase 2: Arm A and Arm D: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine, Phase 2: Arm B: LBL-007 + bevacizumab + fluoropyrimidine, Phase 2: Arm C and Arm E: bevacizumab + fluoropyrimidine, Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil (5-FU)
Colorectal Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT05609370 — Phase 1 & 2
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05609370 — Phase 1 & 2
~149 spots leftby Apr 2028