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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 44 months

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

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3960