Phase I Study of SYS6023 Given by Intravenous Infusion in Adults with Advanced Solid Tumors

What this Trial Is About

This research aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary effectiveness of SYS6023, a novel antibody-drug conjugate, in participants with advanced solid tumors. The study is an open-label, dose-escalation and cohort-expansion Phase I trial conducted at multiple centers. It includes patients with various advanced solid tumors, including specific subtypes of breast and lung cancers, ovarian cancer, and other HER3-positive tumors. Participants will receive SYS6023 through intravenous infusion on the first day of each 3-week treatment cycle. Different cohorts receive escalating doses ranging from 0.5 mgkg to 6.5 mgkg or the recommended dose. The treatment continues until disease progression, unacceptable toxicity, new anti-tumor therapy initiation, withdrawal, loss to follow-up, or death. The study includes dose-escalation and multiple cohort-expansion groups to assess the drugs effects in specific tumor types. During the study, participants undergo regular assessments including monitoring for dose-limiting toxicities, adverse events, and serious adverse events up to 28 days after the last dose. Pharmacokinetic measures such as plasma concentration and anti-drug antibodies will be evaluated for up to four years. Tumor response, disease control, progression-free survival, and overall survival are also tracked. Safety and tolerability are monitored throughout, with participation lasting approximately up to two years or longer depending on outcomes and follow-up assessments.

A Clinical Study of SYS6023 in Patients With Advanced Solid Tumors