Study of BGB-A425 and LBL-007 in Combination With Tislelizumab in Advanced Solid Tumors
About the study
Who can take part
INCLUSION CRITERIA
Key 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, not tolerated or refused.
- 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
Key Exclusion Criteria:
- NSCLC patients with known EGFR mutation, BRAF mutation, ALK fusion, or ROS1 fusion
- 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
- 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
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Locations
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How to Apply
Study Details
Contition
Locally Advanced or Metastatic Solid Tumors for Phase 1,Dose Escalation and Phase 2 Safety Lead-in, HNSCC, NSCLC and RCC Participants for Phase 2
Age
18+
Phase
PHASE1/PHASE2
Participants Needed
358
Est. Completion Date
Dec 29, 2027
Treatment Type
INTERVENTIONAL
Sponsor
BeiGene
ClinicalTrials.gov NCT Identifier
NCT03744468
Study Number
BGB-900-102
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