Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This trial has three parts; dose escalation (phase I), dose expansion (phase II) and a China sub-study.
Conditions
This trial is treating people with advanced solid cancers
Eligibility
Inclusion
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
- 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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
BeiGene Australia Pty Ltd
Scientific Title
Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIM-3 Monoclonal Antibody BGB-A425 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
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