Phase III Study of Oral AMXI-5001 for Treating Advanced Cancers Open Label Dose Escalation and Expansion in Adults

What this Trial Is About

Researchers are evaluating AMXI-5001, an oral drug that blocks PARP and microtubule polymerization, in adults with advanced cancers that have not responded to other treatments. This Phase III trial aims first to find the best dose and then to study the drugs safety and effects in more detail. The study includes participants with several types of advanced cancers, including breast, ovarian, prostate, pancreatic, and other malignant tumors. The trial has two parts Phase I involves dose escalation, where up to 70 participants receive AMXI-5001 orally twice a day with food on a weekly continuous 7-day schedule, with each treatment cycle lasting 28 days. After determining the recommended dose, Phase II will enroll up to 52 participants to further assess safety, drug levels in the blood, and anti-tumor activity using the chosen dose. All participants receive the study drug as monotherapy. Participants will be monitored for safety, drug concentration in plasma, and tumor response using standard imaging and laboratory tests over approximately 24 months. The primary goals include finding the maximum tolerated dose and recommended dose for Phase II, as well as characterizing the safety profile. Participants must consent and meet eligibility criteria related to their cancer status and overall health. The trial will continue until about October 2026.

A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies