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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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b: Number of participants with Adverse events (AE) and Serious AEs (SAE)
Upper arm
Secondary outcome measures
Upper arm
Phase 1b: Apparent Volume of Distribution (Vz) of LBL-007
Phase 1b: Area Under the Concentration Curve from Day 0 to Day 21(AUC 0-21)
+17 moreTrial 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
~3420
Tislelizumab
2018
Completed Phase 3
~4260
5-Fluorouracil
2012
Completed Phase 3
~7800
Find a Location
Who is running the clinical trial?
BeiGeneLead Sponsor
175 Previous Clinical Trials
28,599 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with an anti-EGFR antibody.I have received treatments that boost or target my immune system.My cancer cannot be surgically removed after initial treatment, according to my doctor.My cancer has not worsened after initial treatment.My cancer has a BRAF V600E mutation.I started my current cancer treatment less than 6 months after finishing my last chemotherapy or radiotherapy.My colorectal cancer is at stage IV and cannot be surgically removed.I have colorectal cancer and have only had first-line therapy for it in the metastatic stage.My cancer is confirmed to be MSI-H or has dMMR.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b: Cohort 2: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
- Group 2: Phase 1b: Cohort-1: LBL-007 + tislelizumab + bevacizumab + capecitabine
- Group 3: Phase 1b: Cohort 1a: LBL-007 + tislelizumab + bevacizumab + capecitabine
- Group 4: Phase 2: Arm A and Arm D: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
- Group 5: Phase 2: Arm B: LBL-007 + bevacizumab + fluoropyrimidine
- Group 6: Phase 2: Arm C and Arm E: bevacizumab + fluoropyrimidine
- Group 7: Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil (5-FU)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any eligibility criteria that must be met to participate in this experiment?
"According to clinicaltrials.gov, this medical trial is actively searching for volunteers; the study was originally posted on January 29th of 2023 and its most recent modification took place on April 11th of the same year."
Answered by AI
What is the enrollment cap for this research project?
"Correct. Clinicaltrials.gov attests that this research project, first posted on January 29th 2023, is actively recruiting participants. The study requires 202 people from 11 sites to participate in the trial."
Answered by AI
In what regions is this experiment being conducted?
"The medical study is being conducted at 11 centres, which include Billings, Rio Piedras and Benowa in addition to other locales. To reduce travel costs for participants, it's prudent to select a trial site close by."
Answered by AI
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