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Not yet recruitingNCT07649200SNH-118110Updated Jun 16, 2026

Study of SNH-118110 in Advanced Solid Tumors

A Phase 1 interventional study of SNH-118110 Soft Capsules in Solid Tumors, sponsored by ScinnoHub Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by ScinnoHub Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
240
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Solid Tumors

Keywords

  • Advanced Solid Tumors
  • Medullary Thyroid Cancer
  • Non-Small Cell Lung Cancer
03

In context

Carcinoma, Medullary

65 studies on the registry are indexed under Carcinoma, Medullary; 17 are open to participants now.

This study's planned enrollment of 240 is above the median of 41 across 49 interventional studies indexed under Carcinoma, Medullary.

Browse Carcinoma, Medullary studies →

Lead sponsor

ScinnoHub Pharmaceutical Co., Ltd. is the lead sponsor of 6 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    SNH-118110

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

    Drug: SNH-118110 Soft Capsules

Interventions

  • DrugSNH-118110 Soft Capsules

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

06

What researchers measure

Primary outcomes

  1. Safety evaluation

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).

    Time frame: Up to approximately 2 years

  2. 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)

    Time frame: Cycle 1 (up to 21 days)

Secondary outcomes

  1. The maximum concentration (Cmax)

    Cmax of SNH-118110

    Time frame: Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)

  2. Time of the maximum concentration (Tmax)

    Tmax of SNH-118110

    Time frame: Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)

  3. Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC0-t)

    AUC0-t of SNH-118110

    Time frame: Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)

  4. Elimination half-life (t1/2)

    T1/2 of SNH-118110

    Time frame: Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)

  5. Objective response rate (ORR)

    ORR of SNH-118110 evaluated by investigators per RECIST v1.1

    Time frame: Up to approximately 2 years

  6. Disease control rate (DCR)

    DCR of SNH-118110 evaluated by investigators per RECIST v1.1

    Time frame: Up to approximately 2 years

  7. Duration of response (DoR)

    DoR of SNH-118110 evaluated by investigators per RECIST v1.1

    Time frame: Up to approximately 2 years

  8. Progression-free survival (PFS)

    PFS of SNH-118110 evaluated by investigators per RECIST v1.1

    Time frame: Up to approximately 2 years

  9. Overall survival (OS)

    Overall survival (OS)

    Time frame: Up to approximately 2 years

07

Study locations

1 site
  • The East Hospital Affiliated to Tongji University, Shanghai
    Shanghai, Shanghai Municipality 200120, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07649200
Lead sponsor
ScinnoHub Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jun 16, 2026
Start date
Jun 26, 2026 (estimated)
Primary completion
Jun 26, 2027 (estimated)
Completion
Jun 26, 2029 (estimated)
Last update
Jun 16, 2026

Study contacts

Caicun Zhou, MD
Contact
CAICUNZHOUDR@TONGJI.EDU.CN
86 021-58822171

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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