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A Phase I Study of SY-9453 in Patients With Advanced Solid Tumors

NCT07469982 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2026-04-27

No results posted yet for this study

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.

Conditions

  • Advanced or Metastatic Solid Tumors With Homozygous MTAP Deletion

Interventions

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.

Sponsors & Collaborators

  • Shanghai East Hospital

    collaborator OTHER

  • Shouyao Holdings (Beijing) Co. LTD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-12
Primary Completion
2027-02-28
Completion
2029-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07469982 on ClinicalTrials.gov