Phase 1 Study of MGC028 Antibody-Drug Conjugate in Adults With Advanced Solid Tumors Expressing ADAM9

What this Trial Is About

Researchers are evaluating MGC028, an antibody-drug conjugate targeting ADAM9, in adults with relapsed or refractory advanced solid tumors that cannot be surgically removed or have spread. The study aims to understand the safety, side effects, dose-limiting toxicities, and the maximum tolerated dose of MGC028. It also seeks to determine if MGC028 can shrink or control the progression of these cancers, including types such as non-small cell lung cancer adenocarcinoma, cholangiocarcinoma, pancreatic carcinoma, and colorectal carcinoma. Participants receive MGC028 through intravenous infusions at increasing dose levels every three weeks. The study includes dose escalation cohorts followed by expansion cohorts at the maximum tolerated or maximum administered dose. Treatment is administered in cycles, with dose levels ranging from 1 to 6 and additional expansion cohorts to further evaluate safety and response. During the trial, participants undergo screening to confirm eligibility, regular blood tests for routine and research purposes, and examinations to assess heart and lung function and overall health. Researchers monitor side effects and provide treatment if needed. Tumor status is assessed at regular intervals to evaluate response to MGC028. Outcome measures include the number and types of adverse events over up to 25 months, drug concentration levels in the blood, development of anti-drug antibodies, tumor response rates, duration of response, and changes in ADAM9 expression in tumor samples.

A Study of MGC028 in Participants With Advanced Solid Tumors