Phase 1 Study of PTX-912 Given by IV Infusion in Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and tolerability of increasing doses of PTX-912 in patients with locally advanced or metastatic solid tumors who have had disease progression after standard treatments or have no beneficial standard care options. The study also aims to assess how the body processes PTX-912 and its immune response profile, along with preliminary anti-tumor activity. This is a first-in-human, phase I trial led by Proviva Therapeutics, Inc. Participants will receive PTX-912 through intravenous infusion every two weeks. Treatment will continue until the disease progresses, unacceptable side effects occur, or a total of 12 months of therapy is completed. The study uses a dose escalation design where patients receive single or multiple ascending doses of PTX-912. During the trial, participants will undergo regular visits for assessments including blood tests to monitor bone marrow and organ function, scans to measure tumor response, and evaluations of side effects. Researchers will particularly track dose limiting toxicities within the first 28 days. Participants must be able to comply with study visits and procedures, and their health status will be closely monitored throughout the treatment period, which may last up to one year.

A First-in-human (FIH), Phase I Study of PTX-912 in Patients with Locally Advanced/Metastatic Solid Tumors