AMXI-5001 for Advanced Cancers
This study is testing a new oral medication called AMXI-5001 for adults with advanced cancers, including breast, ovarian, and prostate cancer, that have not responded to other treatments or for which you cannot tolerate existing therapies. AMXI-5001 works by targeting PARP (poly ADP ribose polymerase), a protein involved in DNA repair. The study has two parts: the first part will find the best dose of AMXI-5001, and the second part will further evaluate its safety and effectiveness. The main goals are to determine the safest and most effective dose and to understand any side effects. The study plans to enroll about 122 participants.
- Study design
- This is a Phase I/II, open-label study with about 122 participants. All participants will receive AMXI-5001 as a single treatment.
- What's involved
- Participants will take AMXI-5001 orally twice daily with food. Each treatment cycle is 28 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will characterize the safety profile of AMXI-5001 for approximately 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
At a glance
Conditions
Where it's being run
4 sites across 4 statesStudy leadership
- Pamela Munster, MD · STUDY_DIRECTOR · AtlasMedx, Incorporated
Who to contact
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What this trial measures
- Determine the Maximum Tolerated Dose (MTD)Approximately 12 months
The highest dose is defined at which no more than 1 of 6 evaluable participants has had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria and determination by Investigator and Data and Safety Monitoring Committee.
- Determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapyApproximately 12 months
The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.
- Characterize safety profile of AMXI-5001Approximately 24 months
The safety profile of AMXI-5001 is defined by the incidence of treatment emergent adverse events, laboratory abnormalities, and ECG measurements.