Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT03744468
Eligibility 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
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03744468
Study Brief:
Protocol Section:
NCT03744468