Phase 1 Study of MPD-1 Drug Safety and Dosage in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are conducting a Phase I, open-label clinical trial at a single center to study MPD-1 in patients with advanced solid tumors. This trial aims to evaluate the safety, tolerability, and how the body processes MPD-1, a prodrug that targets KRAS mutant or PTEN loss cancers. The study focuses on patients who have metastatic or unresectable tumors unresponsive to existing standard therapies. Participants will receive MPD-1, which uses Doxorubicin to target specific cancer mutations. The trial involves dose escalation to find the maximum tolerated dose and the recommended dose for further studies. Treatment duration and response will be closely monitored over an 18-week period, with pharmacokinetic measurements taken from the first treatment day through one week afterward. During the trial, participants will undergo regular assessments including laboratory tests to check blood counts and organ function, as well as electrocardiograms to monitor heart activity. Researchers will evaluate treatment-related side effects and drug levels in the body. The study involves ongoing monitoring from the first dose up to 18 weeks to determine safety and dosing, with participants expected to have measurable or assessable tumors and adequate organ function before enrollment.

Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of MPD-1 in Patients With Advanced Solid Tumor