Phase 1 Open-Label Study of CTX-8371 Safety and Tolerability in Adults With Advanced Cancer

What this Trial Is About

Researchers are studying CTX-8371, a new drug given as a monotherapy to patients with advanced cancers that have spread or cannot be removed by surgery. This Phase 1 open-label trial aims to evaluate the safety, tolerability, immune response, and how the drug behaves in the body. It also looks at early signs of the drugs effect on tumors. The study involves patients with several cancer types including non-small cell lung cancer, triple negative breast cancer, Hodgkin lymphoma, head and neck squamous cell carcinoma, and malignant melanoma. Participants are divided into two groups a Dose Escalation group and a Dose Expansion group. In the Dose Escalation group, patients receive increasing doses of CTX-8371 through intravenous infusion every two weeks, testing doses from 0.1 to 10.0 mgkg. The Dose Expansion group receives either 3.0 mgkg or 10.0 mgkg of CTX-8371, also by intravenous infusion every two weeks, allocated evenly between doses. This approach helps find the best dose to study further and assess safety at different levels. During the study, participants receive infusions every two weeks and undergo regular evaluations including tumor assessments using recognized criteria, blood tests to monitor drug levels and immune response, and safety checks. These assessments continue during treatment and for up to two years after the last dose to monitor disease progression, response duration, survival, and drug effects. The study also carefully tracks side effects and overall tolerability, with participation lasting about six months for dose escalation patients and up to two years for dose expansion patients.

A Phase 1 of CTX-8371 in Patients With Advanced Malignancies