RecruitingPhase 1NCT06970795

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


Sponsor

CSPC Megalith Biopharmaceutical Co.,Ltd.

Enrollment

180 participants

Start Date

Apr 10, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing SYS6040 — a new injectable drug — in people with advanced solid tumors or small cell lung cancer (SCLC) that have not responded to standard treatments, to find out how safe it is, how much to give, and whether it shows signs of working. **You may be eligible if...** - You are 18 or older with a solid tumor confirmed by biopsy that has progressed despite standard treatments - For the expanded cohort: you have small cell lung cancer (SCLC) that has failed at least one platinum-based chemotherapy regimen - You are in generally good health with acceptable organ function - You have measurable or evaluable disease on imaging **You may NOT be eligible if...** - You have received certain prior treatments or are within a required washout period from your last therapy - You have uncontrolled brain metastases - You have severe organ failure, uncontrolled infections, or active autoimmune disease - You are pregnant or breastfeeding - You have known allergy to components of the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSYS6040 for injection

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)

Jilin Cancer Hospital

Changchuan, Jilin, China

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NCT06970795


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