OncoMatch/Clinical Trials/NCT06970795
A Study of SYS6040 for Injection in Patients With Advanced Solid Tumors
Is NCT06970795 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies SYS6040 for for small cell lung cancer.
Treatment: SYS6040 for — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Tumor Agnostic
Biomarker criteria
Required: DLL3 positive
Disease stage
Metastatic disease required
At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — SCLC
SCLC subjects who failed or were intolerant to at least one prior platinum-containing chemotherapy regimen
Cannot have received: antibody-drug conjugate
Exception: containing topoisomerase I inhibitors as payload
Previous treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors as payload
Lab requirements
Blood counts
Neutrophil count ≥1.5×10^9/L; Platelet count ≥100×10^9/L; Hemoglobin ≥9 g/dL
Kidney function
Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min
Liver function
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)
Laboratory parameters meeting the following criteria: Neutrophil count ≥1.5×10^9/L; Platelet count ≥100×10^9/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; INR or APTT ≤1.5×ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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