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A Phase I Study of SY-9453 in Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

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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

NCT07469982•Shouyao Holdings (Beijing) Co. LTD

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must meet all of the following criteria to be eligible for this study:
•1. Subjects voluntarily participated in this study and signed the written informed consent (ICF);
•2. Age ≥ 18 years at the time of signing the Informed Consent Form (ICF);
•3. Histologically or cytologically confirmed locally advanced solid tumor and disease progression or intolerance after adequate standard treatment, or lack of standard treatment options.
•For subjects participating in the dose escalation phase (only for dose groups of 30 mg and above) and the dose expansion phase: be able to provide a previous test report confirmed by NGS or IHC to be homozygous deletion of the MTAP gene approved by the investigator, or agree to provide sufficient archived or baseline tumor tissue samples, confirmed to be homozygous deletion of the MTAP gene by central laboratory testing.
•4.At least one measurable extracranial lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 criteria or mRECIST V1.1（Mesothelioma subjects only）(subjects participating in accelerated titration phase are not required to meet this requirement).
•5.Expected survival of \>3 months. 6.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 7.Organ function levels must meet the following requirements:
•1. No blood products, hematopoietic growth factors (e.g., G-CSF, thrombopoietin, erythropoietin, platelet transfusion, whole blood transfusion, red blood cell transfusion), or other drugs that correct abnormal blood counts for at 14 days before first dosing and the following blood counts: ANC ≥ 1.5 × 10\^9/L, PLT count ≥ 100 × 10\^9/L, Hb ≥ 90 g/L.
•2. Renal function: Creatinine clearance (Ccr) ≥ 60 mL/min (calculated using the Cockcroft and Gault formula).
•3. Liver function: TBIL ≤ 1.5 × upper limit of normal (ULN), and AST and ALT ≤ 2.5 × ULN; in the presence of liver metastases, AST and ALT ≤ 5.0 × ULN, and serum albumin ≥ 30 g/L.
+2 more criteria

Exclusion Criteria

•1\. Patients previously treated with a MAT2A inhibitor or PRMT5 inhibitor. 2. History of allergy to any component or excipient of SY-9453 capsules. 3. Received the following treatments prior to the first dose:
•1. Small-molecule targeted drugs within 2 weeks(or 5 half-lives, whichever is shorter).
•2. Hormonal anti-tumor therapy within 2 weeks or as judged by the investigator.
•3. Chinese herbal medicine or preparations with indications for anti-tumor therapy or tumor adjuvant therapy within 2 weeks or as judged by the investigator.
•4. Radiotherapy within 4 weeks (with 2 weeks if the radiotherapy was palliative stereotactic radiotherapy that did not involve the lungs, abdomen and pelvis)
•5. Chemotherapy: fluorouracil, leucovorin, and/or weekly paclitaxel with 2 weeks; nitrosourea or mitomycin C with 6 weeks; other chemotherapy with 3 weeks.
•6. Other investigational drugs with 4 weeks.
•7. Biotherapy within 4 weeks(or 5 half-lives, whichever is longer)
•8. Immunotherapy within 4 weeks.
•9. Major surgery within 4 weeks (excluding central venous catheter insertion, bone marrow biopsy and gastric tube insertion).
+25 more criteria

Locations (1)

Shanghai East Hospital

Shanghai, China

Key Dates

Start Date

February 1, 2026

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2029

Last Updated

March 13, 2026

Enrollment

122

ESTIMATED participants

Conditions

Advanced or Metastatic Solid Tumors With Homozygous MTAP Deletion

Interventions

SY-9453

DRUG

Contacts

chen guang wang

CONTACT

010-8885-8866 cgwang@centaurusbio.com