Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Tislelizumab

Immunoglobulins

Antineoplastic Agents, Immunological

Different groups of participants will receive increasing doses of BGB-A3055 alone to determine the most appropriate dosage levels.

Different groups of participants will receive increasing doses of BGB-A3055 in combination with tislelizumab to determine the most appropriate dosage levels.

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.

BGB-A3055

BeiGene

Study Director

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.

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.

A Study of BGB-A3055, Alone and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors

A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-A3055, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, and NCI-CTCAE v5.0.

The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%

The RDFEs of BGB-A3055, alone and in combination with tislelizumab will be determined based on relevant data.

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

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

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

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

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

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

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

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, physical examination findings, and electrocardiogram results.

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.

Spots Global Cancer Trial Database for preliminary antitumor activity