Study of SNH-118110 in Advanced Solid Tumors

This is a multicenter, open-label, Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SNH-118110 administered orally. The study consists of a dose-escalation phase and a dose-expansion phase.

Inclusion Criteria: * Ability to understand and voluntarily sign an informed consent form (ICF) prior to any study related procedures. * Age ≥ 18 years at the time of signing the ICF. * Histologically or cytologically confirmed diagnosis of advanced solid tumors, with the following additional requirements: Dose-escalation phase: Patients with advanced solid tumors harboring a RET gene alteration who have failed standard therapy or are intolerant to standard therapy. Dose-expansion phase: Cohort 1: Locally advanced or metastatic NSCLC with RET gene fusion who have progressed after at least one prior line of therapy, which must include a RET inhibitor. Cohort 2: Treatment-naïve patients with locally advanced or metastatic NSCLC harboring a RET gene fusion. Cohort 3: Other advanced solid tumors harboring RET gene alterations. * At least one measurable target lesion according to RECIST version 1.1. * Documentation of a RET fusion or other activating RET gene alteration (based on a local or central laboratory report). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within the 2 weeks prior to the first dose of study drug. * Life expectancy of at least 3 months. Exclusion Criteria: * Presence of other known oncogenic driver mutations. * Prior anti-tumor therapy within specified washout periods prior to first dose (e.g., small molecules, biologics, radiotherapy, major surgery), or failure to recover from clinically significant toxicities. * Clinically significant uncontrolled or active conditions, including but not limited to: Inadequate bone marrow, hepatic, or renal function. Significant cardiovascular disease (e.g., uncontrolled hypertension, prolonged QTc, poor ejection fraction, recent thromboembolic events). Active or uncontrolled infections, bleeding diathesis, or significant pleural/abdominal/pericardial effusion requiring intervention. Central nervous system metastases unless stable and asymptomatic off steroids. * Conditions affecting oral drug absorption or gastrointestinal function. * History of severe allergic reactions to similar agents. * Pregnant or lactating women, or patients with serious concurrent medical or psychiatric conditions that would compromise safety or study compliance.