Study of SNH-118110 in Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SNH-118110 Soft Capsules.
- Who it may be relevant to
- Registry conditions: Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SNH-118110 in Patients With Advanced Solid Tumors
Overview
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.
Detailed description
This first-in-human, open-label, multicenter Phase I study is designed to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of SNH-118110 administered orally. The study comprises two sequential parts: a dose-escalation phase to identify the maximum tolerated dose (MTD) or maximum administered dose (MAD), followed by a dose-expansion phase to further evaluate safety and anti-tumor activity. The primary endpoints include safety, MTD, and/or MAD.
Interventions
- Drug SNH-118110 Soft Capsules
Participants will continue treatment until progression of disease or the end of the study.
Primary outcome measures
- Safety evaluation [Time frame: Up to approximately 2 years]
- Maximum tolerated dose (MTD) or maximum administered dose (MAD) [Time frame: Cycle 1 (up to 21 days)]
Secondary outcome measures (9)
- The maximum concentration (Cmax) [Time frame: Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)]
- Time of the maximum concentration (Tmax) [Time frame: Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)]
- Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC0-t) [Time frame: Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)]
- Elimination half-life (t1/2) [Time frame: Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)]
- Objective response rate (ORR) [Time frame: Up to approximately 2 years]
- Disease control rate (DCR) [Time frame: Up to approximately 2 years]
- Duration of response (DoR) [Time frame: Up to approximately 2 years]
- Progression-free survival (PFS) [Time frame: Up to approximately 2 years]
- Overall survival (OS) [Time frame: Up to approximately 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The East Hospital Affiliated to Tongji University, Shanghai — Shanghai
Identifiers
NCT: NCT07649200 · SNH-118110-101