Clinical trial · Interventional
Study of SNH-118110 in Advanced Solid Tumors
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SNH-118110 in Patients With Advanced Solid Tumors
NCT07649200CI-TRIAL-00114906SNH-118110not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SNH-118110 Soft Capsules | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SNH-118110
- description
- Dose escalation: Multiple doses of SNH-118110 Dose expansion: MTD/MAD/recommended expansion dose
- interventionNames
- Drug: SNH-118110 Soft Capsules
Primary outcomes (2)
- measure
- Safety evaluation
- timeFrame
- Up to approximately 2 years
- description
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
- measure
- Maximum tolerated dose (MTD) or maximum administered dose (MAD)
- timeFrame
- Cycle 1 (up to 21 days)
- description
- Determination of the MTD or MAD of oral SNH-118110 by the number of participants who experience a dose limiting toxicity (DLT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.