USO 25037
A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination with an anti-PD-1 Antibody in Patients with STK11-Mutated Advanced Solid Tumors (TNG260-C101)
Disease Types: Solid Tumors Research
Eligibility Requirements:
• Histologically or cytologically confirmed diagnosis of a locally advanced or
metastatic solid tumor with measurable disease per RECIST 1.1
• Arm 1: NSCLC with KRAS mutation
• Arm 2: NSCLC with KRAS wild type
• Arm 3: Solid tumors except NSCLC
• Subjects must have at least 1 documented STK11 mutation identified
through a validated analytical method and is annotated as a loss-offunction (LOF) mutation
• Subjects should have be tested for known driver mutations/alterations and
have received at least 1 SOC targeted therapy for the known alteration
• Subject must have disease progression on approved SOC, no SOC exists,
intolerant to SOC, or SOC treatment deemed not appropriate
• Subjects with uncontrolled tumor-related pain are excluded
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