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Anti-tumor agent
BGB-B167 + Tislelizumab for Solid Cancers
Phase 1
Waitlist Available
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 up to approximately 3 years
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of a new cancer drug, given alone or with another new cancer drug.
Who is the study for?
Adults over 18 with advanced solid tumors that can't be surgically removed or have spread, and who've tried standard treatments without success or can't tolerate them. They must be relatively healthy (ECOG ≤1) and not have had another cancer in the last 3 years, no active autoimmune diseases, brain metastasis, or severe allergies to similar drugs.Check my eligibility
What is being tested?
The trial is testing BGB-B167 alone and combined with Tislelizumab for safety and how it affects the body (pharmacokinetics). It's also looking at whether these treatments shrink tumors in patients with certain types of advanced solid cancers.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system since both BGB-B167 and Tislelizumab are monoclonal antibodies. These could range from mild allergic reactions to more serious conditions affecting organs due to an overactive immune response.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1a: Maximum tolerated dose (MTD)
Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
+3 moreSecondary outcome measures
Phase 1a and 1b: Area under the concentration-time curve in 1 dosing interval (AUCtau) of BGB-B167
Phase 1a and 1b: Clinical Benefit Rate (CBR)
Phase 1a and 1b: Disease Control Rate (DCR)
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Phase 1b: Dose ExpansionExperimental Treatment2 Interventions
BGB-B167 alone or in combination with tislelizumab (BGB-A317)
Group II: Phase 1a: Dose EscalationExperimental Treatment2 Interventions
Part A: Increasing dose levels of BGB-B167 monotherapy; Part B: Increasing dose levels of BGB-B167 in combination with tislelizumab (BGB-A317)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
2018
Completed Phase 3
~4260
Find a Location
Who is running the clinical trial?
BeiGeneLead Sponsor
175 Previous Clinical Trials
28,759 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,207 Previous Clinical Trials
489,625 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I am not pregnant or breastfeeding.My recent lab tests show my organs are working well.I am 18 years old or older.I do not have untreated brain cancer spread or active spinal cord cancer.I haven't had any cancer other than the one being studied in the last 3 years.I have an autoimmune disease that is currently active or might come back.My cancer is advanced, cannot be surgically removed, and I've either tried all standard treatments, can't tolerate them, or they're not expected to help much.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b: Dose Expansion
- Group 2: Phase 1a: Dose Escalation
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.
Is this research project still enrolling participants?
"Affirmative. The clinical trial database, clinicaltrials.gov, reveals that the initiative was initially listed on August 25th 2022 and recently modified on November 17th 2022. 254 participants must be sourced from 3 distinct medical centres for this research to progress properly."
Answered by AI
Has the FDA sanctioned BGB-B167 for clinical use?
"Despite the limited evidence that currently exists, our team has assigned BGB-B167 a safety rating of 1 on a 3 point scale. This is due to it being in Phase 1 trials without enough information pertaining to efficacy and safety."
Answered by AI
What is the highest number of participants in this clinical research?
"Affirmative. According to clinicaltrials.gov, this medical research project is actively recruiting participants since it was first published on August 25th 2022 and recently revised in mid-November of the same year. At present, 254 individuals are sought from 3 sites for participation."
Answered by AI
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