A Study of SYS6040 for Injection in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.
About this trial
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 criteria
Qualifiers
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);
Disqualifiers
Oral fluorouracil agents and small molecule targeted drugs within 2 weeks before first dose or within 5 half-lives (whichever is longer);
Traditional Chinese medicines with antitumor indications within 2 weeks before first dose.
Used or required to use strong CYP3A4 inhibitors/inducers within 2 weeks before first dose or during the study;
Previous treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors as payload;
Trial design
Treatments tested in this trial
- SYS6040 for injection
Treatment groups
180 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov