A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM001 in Patients With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of DM001, an experimental drug, in patients with advanced solid tumors including metastatic breast cancer, non-small-cell lung cancer, gastric cancer, gastroesophageal cancer, and colorectal cancer. This Phase 1, multicenter, open-label study focuses on patients whose cancer has progressed after standard treatments or who cannot receive standard therapy. DM001 is a bispecific antibody-drug conjugate targeting TROP2 and EGFR, delivered intravenously. Participants will receive DM001 as an intravenous infusion lasting about 30 to 60 minutes on Day 1 of each 3-week cycle. The study includes a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase to further evaluate safety and preliminary efficacy. Participants may continue treatment for up to six cycles unless they experience unacceptable side effects, disease progression, or choose to withdraw. The treatment period follows a screening period lasting up to 4 weeks and includes multiple study visits during the first three cycles, with fewer visits in later cycles. During the study, participants will attend up to 17 visits, including frequent visits in the initial treatment cycles and follow-up visits after treatment ends. Assessments include safety monitoring, blood tests to measure drug levels, and evaluations of tumor response using established criteria. The main outcomes studied are dose-limiting toxicities and the highest safe dose of DM001. Secondary outcomes include drug concentration over time and objective tumor response rates. Follow-up visits occur about 21 days after the last dose and again 30 days later to monitor ongoing health and safety.

A Study of DM001 in Patients With Advanced Solid Tumors