Trials / Not Yet Recruiting
Not Yet RecruitingNCT07469982
A Phase I Study of SY-9453 in Patients With Advanced Solid Tumors
An Open-label, Multi-center, Dose-escalation and Dose-expansion Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SY-9453 in Patients With Advanced Solid Tumors
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- Sponsor
- Shouyao Holdings (Beijing) Co. LTD · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, single-arm, multicenter, dose-escalation and dose-expansion, phase I study to the safety, tolerability, pharmacokinetics, and preliminary efficacy of SY-9453 in patients with advanced solid tumors.
Detailed description
The study will be conducted in 2 parts: Dose-escalation phase: Participants will be allocated to one of the seven dose groups ranging from 5mg to 80mg and receive a single dose of SY-9453 capsules.This phase is designed to determine the DLTs (Dose-limiting toxicity) and recommended phase II dose (RP2D) and characterize the safety, tolerability and PK of SY-9453 in patients with advanced solid tumors. Dose-expansion phase: Based on the recommended doses (RDEs) obtained in the escalation phase (possibly 1-2 doses), a dose expansion study will be conducted in 1-3 MTAP homozygous deletion advanced or metastatic solid tumor cohorts, with 10-20 patients per dose in each cohort to further evaluate the safety, tolerability, PK characteristics and anti-tumor activity of SY-9453 to clarify RP2D.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SY-9453 | Dose-escalation phase: Multiple doses of SY-9453 for oral administration ranging from 5mg to 80mg. Dose-expansion phase: RDEs of SY-5007 asdetermined during Dose Escalation. |
Timeline
- Start date
- 2026-02-01
- Primary completion
- 2027-02-01
- Completion
- 2029-02-01
- First posted
- 2026-03-13
- Last updated
- 2026-03-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07469982. Inclusion in this directory is not an endorsement.