NCT06970795

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The dose escalation phase utilizes a BOIN design for dose escalation. Subjects in five predefined dose groups will administer investigational product via intravenous infusion. Subjects will be enrolled in groups of 3 for treatment.The first treatment cycle (21 days) will serve as the DLT observation window, with dose escalation/de-escalation decisions based on DLT occurrences. Each cohort is planned to enroll 20-40 subjects, receiving RP2D doses every 3 weeks (Day 1). Subjects will receive RP2D doses in 21-day treatment cycles until PD, intolerable toxicity, consent withdrawal, loss to follow-up, investigator-determined unsuitability for continued treatment, death, or study termination, whichever occurs first.

Conditions

• Small Cell Lung Cancer
• Other Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	SYS6040 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)

Timeline

• Start date: 2025-04-10
• Primary completion: 2027-02-28
• Completion: 2028-11-30
• First posted: 2025-05-14
• Last updated: 2025-05-14

Locations

1 site across 1 country: China