drugset / Trial / NCT07833735

A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of SYS6043 ± Bevacizumab ± Chemotherapy in Participants With Advanced Solid Tumors

NCT07833735 ↗

Phase 1/2 Not yet recruiting 400 enrolled CSPC Megalith Biopharmaceutical Co.,Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a multicenter, open-label, safety run-in, dose-expansion and cohort-expansion Phase I/II study designed to evaluate the safety, tolerability, PK profile and preliminary anti-tumor efficacy of SYS6043 (a B7-H3-targeted ADC) in participants with advanced/metastatic solid tumors. The trial consists of two phases: the Phase I component is the safety run-in study, and the Phase II component includes the dose-expansion study and cohort-expansion study.

Timeline

Start
2026-10-15
Primary completion
2028-10-15
Completion
2029-10-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody — —
Subject Carboplatin Small molecule — —
Subject SYS6043 Other / unclassified — —

Indications