Testing the capsule drug SNH-118110 in adults with advanced solid tumors

Who can take part

• 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

Who cannot take part

• 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
• Pregnant or lactating women, or patients with serious concurrent medical or psychiatric conditions that would compromise safety or study compliance
• Conditions affecting oral drug absorption or gastrointestinal function
• History of severe allergic reactions to similar agents
• 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
• Presence of other known oncogenic driver mutations