Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors
brief summary
The goal of this clinical trial is to learn if investigational drug called SYS6043 works in adults with advanced or metastatic solid tumors that have spread or cannot be treated with standard therapies. The main goals of the study are to understand how safe SYS6043 is, what side effects it may cause, and what dose can be given safely. Researchers will also study how the drug moves through the body and whether the immune system reacts to it. In addition, the study will look for early signs that SYS6043 may help slow or shrink tumors and explore whether the amount of a tumor protein called B7-H3 is related to how well the treatment works. Participants will: * Provide written informed consent * Undergo screening tests to ensure they are eligible for study treatment * Attend all required study visits and receive SYS6043 by intravenous infusion once every 3 weeks (Q3W), with 21 days as one treatment cycle until the study doctor determines that study treatment should be stopped based on how well a participant is doing on treatment. * Have safety follow-up (SFU), and long-term follow-up. * Be followed until progression.
detailed description
This is a multicenter, open-label, Phase I study of dose escalation, PK expansion, and cohort expansion, aiming to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor efficacy of SYS6043 (a B7-H3-targeted antibody-drug conjugate) in patients with advanced/metastatic solid tumors. It includes three parts, namely dose escalation, PK expansion, and cohort expansion.
Phase Ia dose escalation is the first part (Part 1) of this study. The dose escalation is carried out using BOIN design, to evaluate the MTD/maximum administered dose (MAD) and the RP2D.
Phase Ia PK expansion (Part 2) will be conducted at 2-3 dose levels deemed acceptable (≤MTD) in terms of safety/tolerability as assessed by the SMC, to further evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of SYS6043.
Phase Ib cohort expansion (Part 3) will further evaluate the safety and efficacy of SYS6043 at the selected RP2D dose (1-2 dose levels).
A safety monitoring committee (SMC) will be established for this study. The SMC will continuously review safety during the study period and make decisions on adjustments to dose escalation, addition of new dose groups, recommended doses, and recommended exploratory cohorts. For details, please refer to the SMC Charter.
official title
Phase I Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6043 in Patients With Advanced/Metastatic Solid Tumors