Solid TumorsPhase 1SNH-118110NCT07649200
Study of SNH-118110 in Advanced Solid Tumors
A Phase 1 study testing SNH-118110 Soft Capsules in people with Solid Tumors, run by ScinnoHub Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- SNH-118110 Soft Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2026to 26 Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The East Hospital Affiliated to Tongji University, Shanghai
Shanghai, Shanghai Municipality, 200120
About this study
Official title: 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.
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.
- Conditions
- Solid Tumors
- Being tested
- SNH-118110 Soft Capsules
- Keywords
- Advanced Solid Tumors, Medullary Thyroid Cancer, Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Medullary, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNH-118110 Soft CapsulesDrug
Participants will continue treatment until progression of disease or the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| SNH-118110 | Experimental | Dose escalation: Multiple doses of SNH-118110 Dose expansion: MTD/MAD/recommended expansion dose Receives: Drug: SNH-118110 Soft Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Measured: 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)
Measured: Cycle 1 (up to 21 days)
Secondary outcomes (9)
The maximum concentration (Cmax)
Cmax of SNH-118110
Measured: Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)
Time of the maximum concentration (Tmax)
Tmax of SNH-118110
Measured: 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
Measured: Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)
Elimination half-life (t1/2)
T1/2 of SNH-118110
Measured: 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
Measured: Up to approximately 2 years
Disease control rate (DCR)
DCR of SNH-118110 evaluated by investigators per RECIST v1.1
Measured: Up to approximately 2 years
Duration of response (DoR)
DoR of SNH-118110 evaluated by investigators per RECIST v1.1
Measured: Up to approximately 2 years
Progression-free survival (PFS)
PFS of SNH-118110 evaluated by investigators per RECIST v1.1
Measured: Up to approximately 2 years
Overall survival (OS)
Overall survival (OS)
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start26 Jun 2026 (estimated)
- Primary completion26 Jun 2027 (estimated)
- Study completion26 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ScinnoHub Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649200
- Sponsor's protocol ID
- SNH-118110-101
- Acronym
- SNH-118110
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SNH-118110 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07649200
- Acronym / sponsor ID
- SNH-118110 / SNH-118110-101
- Conditions
- Solid Tumors
- Keywords
- Advanced Solid Tumors, Medullary Thyroid Cancer, Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- ScinnoHub Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2026 (estimated)
- Primary completion
- 26 Jun 2027 (estimated)
- Study completion
- 26 Jun 2029 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNH-118110 | Experimental | Drug: SNH-118110 Soft CapsulesDose escalation: Multiple doses of SNH-118110 Dose expansion: MTD/MAD/recommended expansion dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNH-118110 Soft CapsulesParticipants will continue treatment until progression of disease or the end of the study. | Drug | SNH-118110 |
Primary outcome
Safety evaluation
Time frame: Up to approximately 2 years
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Maximum tolerated dose (MTD) or maximum administered dose (MAD)
Time frame: Cycle 1 (up to 21 days)
Determination of the MTD or MAD of oral SNH-118110 by the number of participants who experience a dose limiting toxicity (DLT)
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNH-118110 Soft Capsules in people with Solid Tumors, run by ScinnoHub Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caicun Zhou, MD (86 021-58822171, CAICUNZHOUDR@TONGJI.EDU.CN), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.