Phase 1 Study of ALX2004 Antibody Drug Conjugate in Adults with Advanced or Metastatic Selected Solid Tumors Including Lung, Head and Neck, Esophageal, and Colorectal Cancers

What this Trial Is About

Researchers are evaluating ALX2004, an antibody drug conjugate targeting EGFR, in adults with advanced or metastatic selected solid tumors including non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and colorectal cancer. This Phase 1, open-label, multicenter study aims to find the appropriate dose and assess safety and response in participants who have previously received treatment for these cancers. The study is sponsored by ALX Oncology Inc. and plans to enroll up to 170 patients. The study includes three parts Phase 1a Dose Escalation with increasing doses of ALX2004 to find a safe dose, Phase 1a Dose Exploration where selected doses are further tested in specific tumor types, and Phase 1b Dose Expansion where the recommended dose is given to more patients. ALX2004 is given by intravenous infusion, and dosing is adjusted depending on the study phase and tumor type. Participants will have regular assessments including safety monitoring for dose limiting toxicities and adverse events, tumor response evaluations using RECIST criteria, and measurement of drug levels in the blood. Follow-up can last up to two years from the first dose. The study records outcomes like overall response rate, progression-free survival, and overall survival to understand ALX2004s effects. The total duration of participation depends on the treatment phase and follow-up period.

A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors