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

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene
• Treatments: Tislelizumab

Criteria

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.