Phase 1/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors

Sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
Study ID
NCT07415863
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced/Metastatic Solid Tumors

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SYS6043 — DRUG
    Subcutaneous injection

Study Details

Phase I/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors This study is a first-in-human phase I/II, multicenter, open-label, dose-escalation trial with PK expansion and cohort expansion, designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary anti-tumor efficacy of SYS6043 (a B7-H3-targeted antibody-drug conjugate) in patients with advanced/metastatic solid tumors. It consists of three parts: dose escalation, PK expansion and cohort expansion.

Key Dates

Start date
Dec 30, 2024
Status verified
Feb 2026
Primary completion
Dec 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
820 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SYS6043
    SYS6043 monotherapy

Primary Outcome Measure

Incidence of AE（adverse events) [ Time Frame: Up to 3 years ]

Central Contacts

Related Studies