Phase 1-2 Study of Intravenous ATTR-01 in Adults With Select Epithelial Solid Tumors Evaluating Safety, Optimal Dose, and Effectiveness of ATTR-01

What this Trial Is About

Researchers are studying ATTR-01, an experimental drug made from a modified common cold virus designed to infect and multiply only in cancer cells. This virus carries an immune therapy drug aimed at helping a participants own immune system target cancer. The trial includes a phase 1 dose escalation and expansion to find the best dose, marking the first time ATTR-01 will be given to humans. If an optimal dose is found, further study sub-protocols will evaluate its potential to treat select epithelial solid tumors. Participants receive ATTR-01 through intravenous injection. The study starts with a phase 1 segment focusing on dose finding and safety. If successful, additional phases may be added to further assess the drugs effect on cancer. The trial includes one experimental group receiving ATTR-01, with no placebo or control group. Expanded access to ATTR-01 outside the trial is not available. During the study, participants will have evaluations including tumor measurements by RECIST version 1.1 criteria, biopsies before and after treatment, and assessments of organ function and immune response. Researchers will monitor safety by tracking adverse events and will measure outcomes like tumor response, disease control, progression-free survival, and overall survival at 1, 2, and 5 years. The trial also evaluates viral persistence and immunogenicity. Participants are expected to comply with hygiene measures to prevent virus spread, and the study follows them for up to several years.

A Study of ATTR-01 in Participants With Select Epithelial Solid Tumours