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A Study of BGB-A3055, Alone and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors
This study aims to test the safety, tolerability, and preliminary anti-tumor activity of BGB-A3055, either alone or in combination with Tislelizumab in participants with advanced or metastatic solid tumors.
Study details:
The primary objective of the study is to assess the safety and tolerability of BGB-A3055 alone or in combination with Tislelizumab during dose escalation and to determine the recommended dose for expansion. During dose expansion, the primary objective will be to assess preliminary anti-tumor activity and further characterize the safety of the recommended dose for expansion. .
Around 318 participants will be enrolled in this study, and they will be assigned to different treatment groups. Both the participants and their doctors will be aware of which treatment group they are assigned to throughout the study. The treatments, BGB-A3055 alone or in combination with Tislelizumab, will be administered intravenously to evaluate their safety and determine the highest dose that can be tolerated by participants.
The study will be conducted at multiple medical centers worldwide. The expected duration of participation in this study is two years. Treatment will continue until participants no longer receive any benefits from the drugs, experience excessive side effects, or decide to withdraw their consent.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-08-21
Primary completion: 2025-02-01
Study completion finish: 2025-02-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05935098
Intervention or treatment
DRUG: BGB-A3055
DRUG: Tislelizumab
Conditions
- • Advanced Solid Tumor
- • Metastatic Solid Tumor
- • Solid Tumor
Find a site
Closest Location:
Linear Clinical Research
Research sites nearby
Select from list below to view details:
Linear Clinical Research
Nedlands, Western Australia, Australia
Chris Obrien Lifehouse
Camperdown, New South Wales, Australia
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Phase 1a Part A: Dose Escalation (BGB-A3055 Monotherapy)
| DRUG: BGB-A3055
|
EXPERIMENTAL: Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab)
| DRUG: BGB-A3055
|
EXPERIMENTAL: Phase 1b (Dose Expansion):
| DRUG: BGB-A3055
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Phase 1a: Number of participants with adverse events (AEs) | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, and NCI-CTCAE v5.0. | Up to 2 Years |
| Phase 1a: Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BGB-A3055 | The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% | Up to 2 Years |
| Phase 1a: Recommended dose for expansion (RDFE) of BGB-A3055 | The RDFEs of BGB-A3055, alone and in combination with tislelizumab will be determined based on relevant data. | Up to 2 Years |
| Phase 1b (Dose Expansion): Objective Response Rate (ORR) | Defined as the proportion of participants with best overall response (BOR) of a complete response (CR) or partial response (PR) as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 2 Years |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Phase 1a (Dose Escalation): Objective Response Rate (ORR) | ORR is defined as the percentage of participants with partial or complete response, as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 2 Years |
| Time to Response (TTR) | Defined as the time from the date of the first administration of study drug(s) to the first determination of an objective response.as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 2 Years |
| Duration of Response (DoR) | Defined as the time from the first determination of an objective response until the first documentation of disease progression or death due to any cause, whichever occurs first, as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 2 Years |
| Disease Control Rate (DCR) | Defined as the proportion of participants with BOR of a CR, PR, or stable disease as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 2 Years |
| Clinical Benefit Rate (CBR) | Defined as the proportion of participants with BOR of a CR, PR, or stable disease lasting ≥ 24 weeks as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 2 Years |
| Number of participants with anti-drug antibodies (ADAs) against BGB-A3055 | Not Specified | Up to 2 Years |
| Number of participants with anti-drug antibodies (ADAs) against tislelizumab | Not Specified | Up to 2 Years |
| Serum concentration of BGB-A3055 at specified time points | Not Specified | Up to 2 Years |
| Phase 1b (Dose Expansion): Progression-Free Survival (PFS) | defined as the time from the date of the first administration of study drug(s) to the date of the first documentation of disease progression or death due to any cause, whichever occurs first, as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 2 Years |
| Phase 1b (Dose Expansion): Number of participants with adverse events (AEs) | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, physical examination findings, and electrocardiogram results. | Up to 2 Years |
| Phase 1b (Dose Expansion) CCR8 expression | Evaluated from participant-derived tumor tissue(s) obtained before and/or after treatment with BGB-A3055 in combination with tislelizumab, and their association with clinical efficacy. | Up to 2 Years |
| Phase 1b (Dose Expansion) PD-L1 expression | Evaluated from participant-derived tumor tissue(s) obtained before and/or after treatment with BGB-A3055 in combination with tislelizumab, and their association with clinical efficacy. | Up to 2 Years |
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