Phase 1 Study of CPO301, an EGFR-Targeting Antibody-Drug, in Adults with Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating CPO301, an antibody drug conjugate, in adults with advanced or metastatic solid tumors who have progressed on prior treatments or are ineligible for standard therapy. This Phase 1 trial aims to assess the safety, tolerability, and optimal dosing of CPO301, as well as its pharmacokinetics, immunogenicity, and preliminary effectiveness, including its relationship to EGFR biomarker mutations. The study is sponsored by Conjupro Biotherapeutics, Inc. The trial has two parts. In Part A, patients receive escalating doses of CPO301 by intravenous injection every three weeks to identify the maximum tolerated dose or recommended phase 2 dose. In Part B, additional patients receive CPO301 at the dose determined safe and tolerable in Part A, focusing on those with non-small cell lung cancer with EGFR mutations and other tumor types. Treatment cycles last 21 days, and dose adjustments may be made based on safety assessments. Participants will provide informed consent, undergo screening to confirm eligibility, and attend study visits to receive CPO301 every three weeks until the study doctor decides to stop treatment. Researchers will monitor participants for disease progression every three months for up to two years. Safety, drug metabolism, immune response, and preliminary antitumor activity will be evaluated throughout the study, which is expected to last about one year for the primary outcomes.

A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors