Study of SNH-118110 in Advanced Solid Tumors
ConditionSolid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorScinnoHub Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
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).
Disqualifiers
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.
Conditions affecting oral drug absorption or gastrointestinal function.
History of severe allergic reactions to similar agents.
Trial design
Treatments tested in this trial
- SNH-118110 Soft Capsules
Treatment groups
240 Participants
are divided into 1 treatment groupLocations
1The East Hospital Affiliated to Tongji University, Shanghai200120, ShanghaiShanghai Municipality, China
Sponsors and collaborators
ScinnoHub Pharmaceutical Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov