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.
Age ≥ 18 years (inclusive), as of the date of signing the Informed Consent Form (ICF).
Phase I Safety Run in Cohort: Participants with solid tumors whose disease has relapsed or progressed during or following standard of care systemic therapy, or who are intolerant to standard of care therapy and for whom no available standard of care treatment exists.
Phase II Dose expansion Stage: Participants with solid tumors whose disease has relapsed or progressed during or following standard of care systemic therapy, or who are intolerant to standard of care therapy and for whom no available standard of care treatment exists.
Cohorts 1/2/3: Platinum sensitive recurrence (platinum sensitive recurrence is defined as disease progression or relapse ≥ 183 days after the last platinum containing chemotherapy).
Participants with non epithelial ovarian carcinoma, clear cell carcinoma, mucinous carcinoma, carcinosarcoma or sarcoma, mixed tumors containing any of the above histologic subtypes, or low grade / borderline ovarian tumors (Phase II expansion cohort only);
Prior exposure to B7 H3 targeted therapy;
Prior treatment with topoisomerase 1 inhibitor based antibody drug conjugates (e.g., trastuzumab deruxtecan);
History of severe cardiac or cerebrovascular disease, e.g., heart failure with NYHA Class ≥ 2, acute coronary syndrome (e.g., myocardial infarction, unstable angina) within 6 months prior to screening, acute cerebrovascular events (e.g., transient ischemic attack, cerebral infarction, cerebral hemorrhage) within 6 months prior to screening;
Single group
SYS6043
DrugParticipants in the experimental group will receive SYS6043, Q3W administered on Day 1 of each cycle..
bevacizumab
DrugParticipants in the experimental group will receive bevacizumab Q3W administered on Day 1 of each cycle.
carboplatin
DrugParticipants in the experimental group will receive carboplatin Q3W administered on Day 1 of each cycle.
Incidence of dose-limiting toxicities (DLTs) -(Phase I: Safety Run-in Study)
Incidence of adverse events (AEs) and serious adverse events (SAEs) assessed by CTCAE 6.0-(Phase I: Safety Run-in Study)
Maximum tolerated dose (MTD) (if any) ) of SYS6043 with or without bevacizumab with or without carboplatin-(Phase I: Safety Run-in Study)
Recommended phase 2 dose (RP2D) of SYS6043 with or without bevacizumab with or without carboplatin-(Phase I: Safety Run-in Study)
PFS based on RECIST v1.1-(Phase I: Safety Run-in Study)
ORR based on RECIST v1.1-(Phase I: Safety Run-in Study)
DoR based on RECIST v1.1-(Phase I: Safety Run-in Study)
DCR by Blinded Independent Central Review (BICR) based on RECIST v1.1-(Phase I: Safety Run-in Study)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
