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Monoclonal Antibodies
BGB-A425 + LBL-007 + Tislelizumab for Solid Cancers
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
Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
Adequate organ function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase 1 and phase 2- approximately 2-3 years each
Awards & highlights
Study Summary
This trial is studying different combinations of two drugs, BGB-A425 and LBL-007, with tislelizumab to see if they are safe and effective.
Who is the study for?
This trial is for adults with certain advanced solid tumors, including specific types of head and neck, lung, or renal cancers. Participants must have a good performance status (able to carry out daily activities), proper organ function, and no major health issues like severe allergies to monoclonal antibodies or uncontrolled diabetes. They should not have received other recent cancer treatments or be part of another clinical study.Check my eligibility
What is being tested?
The study is testing the combination of three drugs: BGB-A425, LBL-007, and Tislelizumab in patients with advanced solid tumors. It's an early-phase trial that includes both initial dose-finding (Phase 1) and later-stage evaluation (Phase 2) to assess safety and effectiveness.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the drugs used, immune-related issues affecting organs due to Tislelizumab which is an immunotherapy drug; as well as general side effects such as fatigue, nausea, skin reactions from BGB-A425 and LBL-007.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
My organs are working well.
Select...
I have an advanced cancer that cannot be removed by surgery and have tried or cannot undergo standard treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ phase 1 and phase 2- approximately 2-3 years each
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phase 1 and phase 2- approximately 2-3 years each
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1 Dose Escalation and Phase 2 Safety lead-in: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Phase 1 Dose Escalation: Maximum Tolerated Dose (MTD)
Phase 2 Dose Expansion: Objective Response Rate (ORR)
Secondary outcome measures
PK Parameter: Area Under the Curve (AUC), 0 to 21 days of BGB-425 and LBL-007
PK Parameter: Clearance (CL) of BGB-425 and LBL-007
PK Parameter: Maximum Concentration (Cmax) of BGB-425 and LBL-007
+8 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Phase 2 Safety Lead-inExperimental Treatment3 Interventions
Dose escalation for Cohort A (LBL-007 + Tislelizumab) and Cohort B (BGB-A425 + LBL-007 + Tislelizumab) in participants with advanced solid tumors
Group II: Phase 2 Dose ExpansionExperimental Treatment3 Interventions
Further explore the safety and clinical activity of BGB-A425 and LBL-007 in combination with Tislelizumab in participants with NSCLC, HNSCC and RCC
Group III: Phase 1 Dose EscalationExperimental Treatment2 Interventions
Dose escalation of BGB-A425 in combination with Tislelizumab in participants with advanced solid tumors
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
28,456 Total Patients Enrolled
Emily LiuStudy DirectorBeiGene
1 Previous Clinical Trials
61 Total Patients Enrolled
Hua-Xin GaoStudy DirectorBeiGene
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently enrolled in another clinical trial for a different treatment.There may be other rules that apply to who can or cannot participate in the study.I have an advanced cancer that cannot be removed by surgery and have tried or cannot undergo standard treatment.I am not on any strong antibiotics, antifungals, or antivirals.I am fully active and can carry on all my pre-disease activities without restriction.My organs are working well.You have or have had an autoimmune disease that could come back.I do not have uncontrolled diabetes or major heart problems.I do not have active brain or spinal cord tumor spread.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 Dose Escalation
- Group 2: Phase 2 Safety Lead-in
- Group 3: Phase 2 Dose Expansion
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.
How many medical centers are actively conducting this research?
"Fifteen clinical sites are offering this trial, located in cities such as Orange, Saint Louis and Chapel Hill. It is advisable to select the closest site possible to avoid excessive travelling if a patient decides to participate."
Answered by AI
How many participants are engaged in this experiment?
"Affirmative. According to clinicaltrials.gov, this ongoing medical trial commenced on November 13th 2018 and was recently updated on November 28th 2022. 358 patients from 15 different sites are needed for the experiment's completion."
Answered by AI
Has BGB-A425 been subject to any other trials prior to this one?
"Since its inception in 2017, BGB-A425 has been studied in 11 completed trials. In the present day, 105 more experiments are actively enrolling patients, with a hefty portion taking place within Orange County California."
Answered by AI
Are there any vacancies available to join this clinical investigation?
"As the information presented on clinicaltrials.gov states, this trial is actively looking for suitable candidates. The initial posting of this study was done in November 2018 and most recently revised on November 28th 2022."
Answered by AI
Is this endeavor the inaugural attempt of its kind?
"BGB-A425 has been in development since 2017, when BeiGene first sponsored its initial 805 participant study. Trodding the path to Phase 3 drug approval, 105 trials are presently active worldwide over 426 cities and 45 nations."
Answered by AI
Who else is applying?
What state do they live in?
Alaska
Wyoming
How old are they?
65+
18 - 65
What site did they apply to?
University of North Carolina and Chapel Hill
Sunshine Western Health Melbourne
Hollywood Privat Hospital
Other
What portion of applicants met pre-screening criteria?
Met criteria
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