Study of SNH-118110 in Advanced Solid Tumors (SNH-118110)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: SNH-118110 Soft Capsules

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Caicun Zhou, MD; Phone Number: 86 021-58822171; Email: CAICUNZHOUDR@TONGJI.EDU.CN

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200120
      • The East Hospital Affiliated to Tongji University, Shanghai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SNH-118110; Dose escalation: Multiple doses of SNH-118110 Dose expansion: MTD/MAD/recommended expansion dose	Drug: SNH-118110 Soft Capsules; Participants will continue treatment until progression of disease or the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation	Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).	Up to approximately 2 years
Maximum tolerated dose (MTD) or maximum administered dose (MAD)	Determination of the MTD or MAD of oral SNH-118110 by the number of participants who experience a dose limiting toxicity (DLT)	Cycle 1 (up to 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum concentration (Cmax)	Cmax of SNH-118110	Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)
Time of the maximum concentration (Tmax)	Tmax of SNH-118110	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)	AUC0-t of SNH-118110	Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)
Elimination half-life (t1/2)	T1/2 of SNH-118110	Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)
Objective response rate (ORR)	ORR of SNH-118110 evaluated by investigators per RECIST v1.1	Up to approximately 2 years
Disease control rate (DCR)	DCR of SNH-118110 evaluated by investigators per RECIST v1.1	Up to approximately 2 years
Duration of response (DoR)	DoR of SNH-118110 evaluated by investigators per RECIST v1.1	Up to approximately 2 years
Progression-free survival (PFS)	PFS of SNH-118110 evaluated by investigators per RECIST v1.1	Up to approximately 2 years
Overall survival (OS)	Overall survival (OS)	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: ScinnoHub Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 26, 2026
• Primary Completion (Estimated): June 26, 2027
• Study Completion (Estimated): June 26, 2029

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer; Advanced Solid Tumors; Medullary Thyroid Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuroendocrine Tumors; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Neuroendocrine; Carcinoma, Non-Small-Cell Lung; Carcinoma, Medullary
• Other Study ID Numbers: SNH-118110-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No