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Monoclonal Antibodies
BGB-A3055 + Tislelizumab for Cancer
Phase 1
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 up to 2 years
Awards & highlights
Study Summary
This trial will test a new drug to see if it's safe and effective against cancer.
Who is the study for?
This trial is for adults with advanced or metastatic solid tumors who have tried all standard treatments or can't tolerate them, and haven't been treated for CCR8 before. They must be relatively healthy (ECOG ≤1), have measurable disease, provide tumor tissue samples, and not have had any other cancer in the last 3 years except the one being studied.Check my eligibility
What is being tested?
The study tests BGB-A3055's safety and effectiveness alone or with Tislelizumab against advanced solid tumors. It looks at how well these drugs work together to fight cancer and what side effects they might cause.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation of organs, fatigue, digestive issues like nausea or diarrhea, skin problems like rash, potential lung issues like pneumonitis, and an increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 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) or maximum administered dose (MAD) of BGB-A3055
Phase 1a: Number of participants with adverse events (AEs)
Phase 1a: Recommended dose for expansion (RDFE) of BGB-A3055
+1 moreSecondary outcome measures
Clinical Benefit Rate (CBR)
Disease Control Rate (DCR)
Duration of Response (DoR)
+9 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Phase 1b (Dose Expansion):Experimental Treatment2 Interventions
Participants will receive the recommended dose for expansion phase (RDFE) of BGB-A3055 in combination with tislelizumab to provide additional information on the safety, tolerability, and potential benefits of the recommended dose.
Group II: Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab)Experimental Treatment2 Interventions
Different groups of participants will receive increasing doses of BGB-A3055 in combination with tislelizumab to determine the most appropriate dosage levels.
Group III: Phase 1a Part A: Dose Escalation (BGB-A3055 Monotherapy)Experimental Treatment1 Intervention
Different groups of participants will receive increasing doses of BGB-A3055 alone to determine the most appropriate dosage levels.
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
28,507 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,211 Previous Clinical Trials
488,954 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at least 18 years old or the legal age of consent in my area.I can perform all my usual activities without help and my organs are functioning well.My advanced cancer is linked to high CCR8, and I've tried all standard treatments or can't tolerate them.I have chronic hepatitis B with high viral load, or I have active hepatitis C or HIV.I do not have untreated brain cancer spread or active spinal cord disease.I haven't had any cancer other than the one being studied in the last 3 years, except for treated local skin, bladder, cervix, or breast cancer.I have a history of serious lung conditions.I can provide tissue samples from my tumor for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab)
- Group 2: Phase 1b (Dose Expansion):
- Group 3: Phase 1a Part A: Dose Escalation (BGB-A3055 Monotherapy)
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 there still an opportunity for patient enrollment in this clinical experiment?
"As per clinicaltrials.gov, this trial is not currently enrolling patients. Initially posted on August 1st 2023 and last updated July 5th 2023, the study has since ceased recruitment - yet 2840 other investigations are presently seeking volunteers."
Answered by AI
To what extent could patients be put at risk by BGB-A3055 Monotherapy in Phase 1a Part A: Dose Escalation?
"Because this is a Phase 1 trial, with limited data concerning efficacy and safety, our team at Power has rated the security of Phase 1a Part A: Dose Escalation (BGB-A3055 Monotherapy) as a score of one."
Answered by AI
How many venues are hosting this clinical trial?
"Currently, 8 trial sites are operational across the United States. These include Hackensack, Dallas and Camperdown in addition to 5 other locales. To minimise travel burdens associated with participating in this study, it is advisable to select a site that is closest to you."
Answered by AI
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