SNH-118110 Soft Capsules: Participants will continue treatment until progression of disease or the end of the study.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Safety evaluation — Up to approximately 2 years Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Maximum tolerated dose (MTD) or maximum administered dose (MAD) — Cycle 1 (up to 21 days) Determination of the MTD or MAD of oral SNH-118110 by the number of participants who experience a dose limiting toxicity (DLT)
Trial sites (1)
Facility
City
Region
Status
The East Hospital Affiliated to Tongji University, Shanghai
Shanghai
Shanghai Municipality
More ScinnoHub Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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