First-in-Human Study Evaluating EMB-15 Safety and Early Anti-Tumor Effects in Adults with Advanced or Metastatic Solid Tumors

What this Trial Is About

This research aims to evaluate the safety and tolerability of EMB-15, a recombinant humanized bi-specific antibody, in adults with locally advanced or metastatic solid tumors who have progressed on standard treatments or lack standard therapy options. It is a first-in-human, open-label, Phase I trial designed to identify the recommended Phase 2 dose and assess pharmacokinetics, pharmacodynamics, immunogenicity, and anti-tumor activity. Participants receive EMB-15 through a dose-escalation study including a screening period up to 28 days, a step-up dose period for higher-risk doses lasting 7 days or more, followed by treatment cycles of 28 days each for up to 2 years. After treatment ends, a safety follow-up period of 30 days is conducted. The study plans to enroll about 50 patients in both dose-escalation and dose-expansion phases. During the study, participants undergo evaluations including monitoring of adverse events, dose interruptions, and dose intensity throughout treatment and follow-up. Measurements include pharmacokinetic parameters, anti-drug antibodies, and tumor response assessments using RECIST 1.1 criteria. The study also tracks progression-free survival and duration of response, with ongoing safety and tolerability monitoring for up to 30 days after the last dose.

A First-in-human Phase I Study to Evaluate EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors.