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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
SYS6040 for injection
DrugIntravenous infusion; including dose escalation and backfilling (5 preset dose groups) and cohort expansion. Treatment Period: All subjects receive trial treatment until disease progression, death, intolerance of toxicity, loss to follow-up, withdrawal of consent, or end of the trial (whichever occurs first)
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: SYS6040 for injection as single agentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
DLT（Phase 1a）
Incidence rate and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SYS6040 treatment
Time frame
Up to approximately 21days2
Frequency and severity of TEAE and SAE（Phase 1a）
Assess safety and tolerability of SYS6040
Time frame
Up to approximately 2years3
RP2D (Phase 1a）
RP2D was determined based on the safety, tolerability, PK, immunogenicity data and efficacy information obtained
Time frame
Up to approximately 2 years4
ORR（Phase 1b）
Objective response rate (ORR) as evaluated by Investigator (RECIST1.1).
Time frame
Up to approximately 2 yearsSecondary outcomes
1
Peak time(Tmax)（phase 1a）
Peak time(Tmax) after a single administration of SYS6040
Time frame
Up to approximately 2 years2
Maximum plasma concentration (Cmax) （phase 1a）
Cmax after a single administration of SYS6040
Time frame
Up to approximately 2 years3
AUC 0-t（phase 1a）
Area under blood concentration - time curve(AUC 0-∞) after a single administration
Time frame
Up to approximately 2 years4
AUC 0-∞（phase 1a）
Area under blood concentration - time curve(AUC 0-∞) after a single administration
Time frame
Up to approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov