Study of SNH-118110 in Advanced Solid Tumors

NCT07649200 | Not Yet Recruiting Phase 1

• 1 other identifier: SNH-118110-101
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumors

Keywords

Advanced Solid Tumors; Medullary Thyroid Cancer; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• The maximum concentration (Cmax)

  Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)

• Time of the maximum concentration (Tmax)

  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)

  Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)

• Elimination half-life (t1/2)

  Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)

• Objective response rate (ORR)

  Up to approximately 2 years

Study Arms (1)

SNH-118110

EXPERIMENTAL

Dose escalation: Multiple doses of SNH-118110 Dose expansion: MTD/MAD/recommended expansion dose

Drug: SNH-118110 Soft Capsules

Interventions

SNH-118110 Soft Capsules DRUG

Participants will continue treatment until progression of disease or the end of the study.

SNH-118110

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ScinnoHub Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The East Hospital Affiliated to Tongji University, Shanghai

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Conditions

Carcinoma, Medullary; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Caicun Zhou, MD

CONTACT

86 021-58822171; CAICUNZHOUDR@TONGJI.EDU.CN

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): June 26, 2027
• Study Completion (Estimated): June 26, 2029
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

CN (1)