A Phase I Study of SY-9453 in Patients With Advanced Solid Tumors (NCT07469982) | Clinical Trial Compass
RecruitingPhase 1
A Phase I Study of SY-9453 in Patients With Advanced Solid Tumors
China122 participantsStarted 2026-03-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects voluntarily participated in this study and signed the written informed consent (ICF);
✓. Age ≥ 18 years at the time of signing the Informed Consent Form (ICF);
✓. Histologically or cytologically confirmed locally advanced solid tumor and disease progression or intolerance after adequate standard treatment, or lack of standard treatment options.
✓.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).
✓.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:
✓. 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.
✓. Renal function: Creatinine clearance (Ccr) ≥ 60 mL/min (calculated using the Cockcroft and Gault formula).
✓. 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.
Exclusion criteria
✕. Small-molecule targeted drugs within 2 weeks(or 5 half-lives, whichever is shorter).
What they're measuring
1
The incidence of adverse events (AEs)
Timeframe: Up to 3 years
2
Incidence of dose limiting toxicities (DLTs)
Timeframe: Escalation phase (35 days after the first dose)
3
Number of Participants With Abnormal Laboratory Values
✕. Hormonal anti-tumor therapy within 2 weeks or as judged by the investigator.
✕. Chinese herbal medicine or preparations with indications for anti-tumor therapy or tumor adjuvant therapy within 2 weeks or as judged by the investigator.
✕. Radiotherapy within 4 weeks (with 2 weeks if the radiotherapy was palliative stereotactic radiotherapy that did not involve the lungs, abdomen and pelvis)
✕. Chemotherapy: fluorouracil, leucovorin, and/or weekly paclitaxel with 2 weeks; nitrosourea or mitomycin C with 6 weeks; other chemotherapy with 3 weeks.
✕. Other investigational drugs with 4 weeks.
✕. Biotherapy within 4 weeks(or 5 half-lives, whichever is longer)