Phase IIIa Study of DM005 Drug Treatment in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and tolerability of an experimental drug called DM005 in patients with advanced solid tumors. This first-in-human, open-label study aims to understand how DM005, a bispecific antibody-drug conjugate targeting c-MET and EGFR, behaves in the body and its preliminary impact on tumor response. Participants must have advanced solid malignant tumors that are not curable by standard local therapies and have progressed on or are intolerant to standard treatments. Participants receive DM005 intravenously on Day 1 of each 21-day cycle. The initial infusion lasts about 60 minutes, and if no infusion-related reactions occur, subsequent infusions may be shortened to about 30 minutes. The study includes a screening period of up to 28 days, followed by multiple treatment cycles, an end-of-treatment visit within 7 days after the last dose, and a follow-up visit about 30 days later. Dose escalation and expansion allow assessment of different dose levels to determine the maximum tolerated dose. During the study, participants will undergo safety evaluations, pharmacokinetic testing, and tumor assessments using RECIST criteria to measure treatment response. Researchers monitor dose-limiting toxicities and other safety data throughout the study. The primary outcomes focus on safety and determining the highest safe dose. Participants can expect regular visits for infusions and assessments over the treatment period, with follow-up visits to monitor ongoing effects, lasting up to 12 months for outcome evaluations.

A Study of DM005 in Patients With Advanced Solid Tumors