Testing the capsule drug SNH-118110 in adults with advanced solid tumors
Tests the oral drug SNH-118110 in adults with advanced solid tumors.
Plain-language title generated from the registry record
Registry title: Study of SNH-118110 in Advanced Solid Tumors
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1
Where in China
- The East Hospital Affiliated to Tongji University, ShanghaiShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ScinnoHub Pharmaceutical Co., Ltd.
- Trial code
- NCT07649200
- Record updated
- 16 June 2026
- Original description
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.Read full original descriptionShow less
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SNH-118110 in Patients With 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: 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: 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.