A Study of SYS6040 for Injection in Patients With Advanced Solid Tumors

Sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
Study ID
NCT06970795
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SYS6040 for injection — DRUG
    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)

Study Details

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.

Key Dates

First listed
May 14, 2025
Start date
Apr 10, 2025
Status verified
Apr 2025
Primary completion
Feb 28, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SYS6040 for injection as single agent

Primary Outcome Measure

DLT（Phase 1a） [ Time Frame: Up to approximately 21days ]

Find similar trials

Nationwide
Lung cancer trialsOncology trialsLung oncology trialsLung disease trials

Related Studies