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An Open-lable, Multicenter Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of SYS6040 for Injection as a Single Agent in Participants With Advanced Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study is the first-in-human Phase I study of SYS6040 for injection, comprising two phases: Dose escalation with backfill (Phase Ia) and cohort expansion (Phase Ib).The planned study population consists of subjects with advanced solid tumors.The objective is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SYS6040 for injection as monotherapy in participants with advanced solid tumors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 1)Aged ≥18 years; 2) Subjects with histologically or cytologically confirmed advanced solid tumors who have failed standard therapy, are intolerant to standard therapy, or have no options of standard of care. During cohort expansion, subjects will be enrolled as follows: Cohort 1: SCLC subjects who failed or were intolerant to at least one prior platinum-containing chemotherapy regimen; Cohort 2: Subjects with DLL3-positive malignant solid tumors who failed standard therapy, are intolerant to standard therapy, or have no options of standard of care.

⁃ 3\) At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1); 4) ECOG score of 0 or 1; 5) Life expectancy ≥3 months; 6) Laboratory parameters meeting the following criteria:

• Neutrophil count ≥1.5×109/L;

• Platelet count ≥100×109/L;

• Hemoglobin ≥9 g/dL;

• Total bilirubin ≤1.5×ULN, ALT and AST ≤2.5×ULN (In cases with liver metastases: total bilirubin ≤3×ULN and ALT/AST ≤5×ULN);

• Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min;

• International Standardized Ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN.

⁃ a. Fertile males and females must use reliable contraception throughout the study period and for 9 months after the last dose. Females aged 18-60 years must have negative blood pregnancy results within 7 days before the first dose.

⁃ 7\) Understand and voluntarily sign the informed consent form (ICF).

Locations
Other Locations
China
Jilin Cancer Hospital
RECRUITING
Changchuan
Time Frame
Start Date: 2025-04-10
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 180
Treatments
Experimental: SYS6040 for injection as single agent
Sponsors
Leads: CSPC Megalith Biopharmaceutical Co.,Ltd.

This content was sourced from clinicaltrials.gov

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