Study of BGB-A425 and LBL-007 in Combination With Tislelizumab in Advanced Solid Tumors

Phase 1

• Conditions: on-Small Cell Lung Cancer, Renal Cell Carcinoma, Head and Neck Squamous Cell Cancer; MedDRA version: 21.0Level: PTClassification code: 10060121Term: Squamous cell carcinoma of head and neck Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10067946Term: Renal cell carcinoma Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-500694-14-00
• Lead Sponsor: Beigene Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-18
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

Has Eastern Cooperative Oncology Group (ECOG) Performance Status =1., Adequate organ function, Phase 1 Dose Escalation + Phase 2 Safety Lead-In: Participants with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who have previously received standard systemic therapy or for which treatment is not available or not tolerated, Phase 2 Dose-Expansion: Participants with one of the following histologically or cytologically confirmed solid tumors: For HNSCC participants in cohort 1,4 and 6 (PD-L1 positive): Recurrent/metastatic head and neck squamous cell cancer of the oral cavity, oropharynx, hypopharynx, and/or larynx whose tumor is not amenable to local therapy with curative intent (ie, surgery or radiation therapy with or without chemotherapy; For NSCLC participants in Cohort 2, 5 and 7 (PD-L1 positive): Locally recurrent Stage IIIB, stage IIIC or Stage IV squamous or non-squamous non-small cell lung cancer; For RCC participants in Cohort 3: Locally advanced unresectable or metastatic and histologically confirmed renal cell carcinoma with a clear cell histology.

Exclusion Criteria

NSCLC patients with known EGFR mutation, BRAF mutation, ALK fusion, or ROS1 fusion, Chemotherapy, radiotherapy, immunotherapy or any investigational therapies within 28 days (PH 2 Safety Lead-In) or 14 days (PH 2 Dose Expansion) or 5 half-lives of (whichever is shorter) of first administration of study drug(s), With infections (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal, or antiviral therapy = 14 days prior to the first dose of study drug(s), or a requirement for chronic prophylactic treatment with antibiotics., Concurrent participation in another therapeutic clinical trial, Received prior therapies targeting TIM-3and/or LAG3, Active leptomeningeal disease or uncontrolled, untreated brain metastasis., Active autoimmune diseases or history of autoimmune diseases that may relapse., Interstitial lung disease, noninfectious pneumonitis or uncontrolled lung diseases, Uncontrolled diabetes or significant cardiac issues, Infections requiring systemic antibacterial, antifungal, or antiviral therapy, History of severe hypersensitivity reactions to other monoclonal antibodies, History of HIV infection or untreated chronic hepatitis B or chronic hepatitis B virus carriers, Major surgical procedure within 28 days before study drug administration

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified