A Study of SYS6040 for Injection in Patients With Advanced Solid Tumors
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
CSPC Megalith Biopharmaceutical Co.,Ltd.
180 participants
Apr 10, 2025
INTERVENTIONAL
Conditions
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
Plain Language Summary
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Interventions
Intravenous 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)
Locations(1)
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NCT06970795