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

NCT07415863 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 820

Last updated 2026-02-17

No results posted yet for this study

Summary

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.

Conditions

  • Advanced/Metastatic Solid Tumors

Interventions

DRUG

SYS6043

Subcutaneous injection

Sponsors & Collaborators

  • CSPC Megalith Biopharmaceutical Co.,Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-30
Primary Completion
2027-12-30
Completion
2028-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07415863 on ClinicalTrials.gov