Study of DM002 Drug for Adults With Advanced Solid Tumors Using Increasing Doses to Find the Best Treatment Level

What this Trial Is About

Researchers are evaluating DM002, an investigational bispecific antibody-drug conjugate targeting MUC1 and HER3, in adults with advanced solid tumors such as ovarian, prostatic, endometrial, colorectal, and pancreatic cancers. This study has two parts Part 1 focuses on finding the safest and most effective dose through dose escalation, while Part 2 expands the evaluation at the best dose found in Part 1 to further assess safety and cancer response. Participants receive DM002 through intravenous infusion on Day 1 every three weeks. Part 1 involves up to six or more dose levels tested sequentially to determine safety and optimal dosing. In Part 2, participants receive the recommended dose established from Part 1. Dose adjustments may occur based on safety and pharmacokinetic data. The treatment cycles last 21 days each. Participants will have at least 17 visits, including a screening phase lasting up to 28 days, treatment cycles every 21 days, an End of Treatment visit 21 days after the last dose, and a Follow-up visit 30 days later. Phone contacts will continue every three months to monitor well-being and any new anticancer therapies started. Researchers will monitor dose-limiting toxicities, maximum tolerated dose, drug levels in the body, and tumor response throughout the 12-month study period.

A Study of DM002 in Patients With Advanced Solid Tumors