Solid Tumors
Conditions
Keywords
Advanced Solid Tumors, Medullary Thyroid Cancer, Non-Small Cell Lung Cancer
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.
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.
Interventions
DRUGSNH-118110 Soft Capsules
Participants will continue treatment until progression of disease or the end of the study.
Sponsors
ScinnoHub Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation | 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) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The maximum concentration (Cmax) | Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days) | Cmax of SNH-118110 |
| Time of the maximum concentration (Tmax) | Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days) | Tmax of SNH-118110 |
| 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) | AUC0-t of SNH-118110 |
| Elimination half-life (t1/2) | Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days) | T1/2 of SNH-118110 |
| Objective response rate (ORR) | Up to approximately 2 years | ORR of SNH-118110 evaluated by investigators per RECIST v1.1 |
| Disease control rate (DCR) | Up to approximately 2 years | DCR of SNH-118110 evaluated by investigators per RECIST v1.1 |
| Duration of response (DoR) | Up to approximately 2 years | DoR of SNH-118110 evaluated by investigators per RECIST v1.1 |
| Progression-free survival (PFS) | Up to approximately 2 years | PFS of SNH-118110 evaluated by investigators per RECIST v1.1 |
| Overall survival (OS) | Up to approximately 2 years | Overall survival (OS) |
Countries
China
Contacts
CONTACTCaicun Zhou, MD
Outcome results
None listed