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

BeiGene

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor; Advanced Solid Tumor; Metastatic Solid Tumor

Treatments: Drug: Tislelizumab; Drug: BGB-A3055

Study type: Interventional

Funder types: Industry

Identifiers

NCT05935098

BGB-A317-A3055-101

2023-505322-34-00 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 318 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age≥18 years on the day of signing the informed consent form (ICF) (or the legal age of consent in the jurisdiction in which the study is taking place, whichever is older).
2. All participants are also required to demonstrate an ECOG Performance Status score of≤1 and have adequate organ function.
3. Participants with histologically confirmed advanced or metastatic solid tumors associated with high CCR8 and who have previously received available standard systemic therapy or for whom treatment is not available or not tolerated and could not receive any prior therapy targeting CCR8.
4. >=1 Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
5. Participants should be able to provide the archival formalin-fixed paraffin-embedded (FFPE) tumor tissues (as block or unstained slides) or fresh biopsy if there is no archival tissue at baseline. For selected cohorts, participants should be willing to provide post-treatment fresh biopsy at specified timepoints.

Exclusion criteria

1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.

2. Active autoimmune diseases or history of autoimmune diseases that may relapse

3. Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).

4. Untreated chronic hepatitis B or chronic HBV carriers with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL) at screening. Participants with active hepatitis C, and participants with HIV infection.

   Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B can be enrolled. Participants with a negative HCV antibody test result at screening or a positive HCV antibody test result followed by a negative HCV RNA test result at screening are eligible to participate. Participants with treated HIV infection may be included if certain criteria are met.

5. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases .

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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318 participants in 3 patient groups

Phase 1a Part A: Dose Escalation (BGB-A3055 Monotherapy)

Experimental group

Description:

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

Treatment:

Drug: BGB-A3055

Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab)

Experimental group

Description:

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

Treatment:

Drug: BGB-A3055

Drug: Tislelizumab

Phase 1b (Dose Expansion):

Experimental group

Description:

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.

Treatment:

Drug: BGB-A3055

Drug: Tislelizumab