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Monoclonal Antibodies
BGB-A445 + Tislelizumab for Advanced 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
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 and a life expectancy of ≥ 6 months.
Participant has not received prior therapy targeting OX40 or any other T cell agonist therapy (prior checkpoint inhibitor therapy is allowed).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes predose up to 72 hours postdose
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and works well when used alone or with another cancer drug.
Who is the study for?
This trial is for adults with advanced solid tumors who've tried standard treatments or can't tolerate them. It's not for those with brain metastasis needing steroids, active autoimmune diseases, recent other cancers except the type studied here, or anyone on immunosuppressants. Participants need good organ function and a performance status indicating they're relatively active.Check my eligibility
What is being tested?
The study tests BGB-A445 alone and combined with tislelizumab to find safe doses and see how well they work against various solid tumors. The trial has two parts: dose escalation to find the maximum tolerated dose and expansion to test this dose in specific tumor types like lung cancer.See study design
What are the potential side effects?
Potential side effects aren't detailed but may include typical reactions from immune therapies such as fatigue, skin reactions, digestive issues, liver enzyme changes, inflammation-related symptoms across different organs due to immune system activation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly active and doctors expect me to live 6 months or more.
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I haven't had treatments targeting T cells, but may have had checkpoint inhibitor therapy.
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I am fully active or can carry out light work.
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My kidney function, measured by GFR, is adequate.
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I have an advanced cancer that cannot be removed by surgery and have tried or cannot try standard treatments.
Select...
I can provide a tissue sample from my tumor for testing.
Select...
I can provide a sample of my tumor tissue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 minutes predose up to 72 hours postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes predose up to 72 hours postdose
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) of BGB-A445
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: Area Under the Concentration-Time Curve of 0-21 Days (AUC0-21d) of BGB-A445
Phase 1a: Disease-Control Rate (DCR) as Assessed by the Investigator
Phase 1a: Duration of Response (DOR) as Assessed by the Investigator
+22 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Phase 1b:BGB-A445 MonotherapyExperimental Treatment1 Intervention
Dose Expansion Part A: Participants will receive recommended doses of IV BGB-A445 as determined from Phase 1a Dose Escalation; BGB-A445 will be evaluated in two tumor types
Group II: Phase 1b: BGB-A445 MonotherapyExperimental Treatment1 Intervention
Dose Expansion Part C: Participants will receive 1 dose level of BGB-A445
Group III: Phase 1b: BGB-A445 + Tislelizumab and Chemotherapy Combination TherapyExperimental Treatment2 Interventions
Dose Expansion Part B: Participants will receive recommended dose IV infusion of BGB-A445 plus 200mg tislelizumab and chemotherapy
Group IV: Phase 1a: BGB-A445 MonotherapyExperimental Treatment1 Intervention
Dose Escalation Part A: Participants will receive intravenous (IV) infusion of BGB-A445 in sequential cohorts of approximately 8 increasing dose levels on day 1 of each 21-day cycle
Group V: Phase 1a: BGB-A445 + Tislelizumab Combination TherapyExperimental Treatment2 Interventions
Dose Escalation Part B: Participants will receive IV infusion of BGB-A445 in sequential cohorts of approximately 6 increasing dose levels plus 200mg tislelizumab on day 1 of each 21-day cycle
Find a Location
Who is running the clinical trial?
BeiGeneLead Sponsor
175 Previous Clinical Trials
28,611 Total Patients Enrolled
Katie WoodStudy DirectorBeiGene
2 Previous Clinical Trials
130 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,207 Previous Clinical Trials
489,477 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My advanced solid tumor has responded to immunotherapy before.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.I am mostly active and doctors expect me to live 6 months or more.I haven't had treatments targeting T cells, but may have had checkpoint inhibitor therapy.I have at least one cancer lesion that can be measured and has either not been treated or has grown after treatment.I haven't had treatments targeting my immune system and I can't or won't use standard cancer treatments.I have advanced NSCLC, can't be cured with surgery or radiation, and had 1-3 treatments.I am fully active or can carry out light work.I have hypothyroidism and am treating it with hormone therapy only.I haven't had any cancer except for the one being studied or minor, treated cancers in the last 2 years.I haven't needed blood support recently and my blood counts and kidney function are within safe ranges.I have head and neck cancer that can't be cured with surgery or radiation, and I've had 1-3 treatments for it.My type 1 diabetes is under control.My organ functions are within normal ranges according to recent tests.I am using corticosteroids that don't significantly enter my bloodstream.I am on a low-dose steroid for adrenal issues (≤10 mg prednisone or equivalent).I have a skin condition like vitiligo, psoriasis, or alopecia that doesn't need treatment through the whole body.My celiac disease is under control.I don't need steroids for brain metastases and have been stable for 4 weeks.I've taken steroids for a short time for allergies or non-autoimmune issues.My kidney function, measured by GFR, is adequate.I have an advanced cancer that cannot be removed by surgery and have tried or cannot try standard treatments.I have not had major surgery within the last 28 days or have fully recovered if it was longer ago.I can provide a tissue sample from my tumor for testing.I can provide a sample of my tumor and am fit for further biopsies as needed.My organ functions are within normal ranges as required.I haven't needed a blood transfusion or growth factor support in the last 14 days.I can provide a sample of my tumor tissue.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b: BGB-A445 Monotherapy
- Group 2: Phase 1a: BGB-A445 + Tislelizumab Combination Therapy
- Group 3: Phase 1b:BGB-A445 Monotherapy
- Group 4: Phase 1a: BGB-A445 Monotherapy
- Group 5: Phase 1b: BGB-A445 + Tislelizumab and Chemotherapy Combination Therapy
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.
What is the scope of participants in this clinical trial?
"Affirmative. According to information found on clinicaltrials.gov, this medical trial has been open for recruitment since the 30th of January 2020 and was last updated at the end of August 2022. 360 participants are needed from a single location."
Answered by AI
To what extent has BGB-A445 been studied in other medical experiments?
"Presently, there are 105 active tests surveying BGB-A445 with 18 investigations in the third phase. While Nanning, Guangxi has a few of these trials running, over two thousand three hundred sites across the world have been allocated to explore this molecular compound."
Answered by AI
What potential risks have been associated with BGB-A445 ingestion?
"On our ranking system at Power, BGB-A445 scored a 1 due to the initial Phase 1 trial that offers limited evidence of safety and efficacy."
Answered by AI
Is this experiment actively seeking participants?
"Affirmative. According to clinicaltrials.gov, this experiment is still recruiting patients and was first advertised on January 30th 2020. The last update was made in August 25th 2022 and the recruitment goal mentioned is 360 people at one site."
Answered by AI
Is there precedent for this trial's methodology?
"Currently, BeiGene's drug BGB-A445 is the subject of 105 active medical studies located in 45 countries and 426 cities. The first trial was launched in 2017 with 805 participants and has since completed its Phase 3 approval stage. In addition, 11 experiments have been concluded since the inception of this research effort."
Answered by AI
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