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

Status Active, not recruiting

Clinical Trial Summary

ATLAS-101 is a Phase I/II clinical trial of AMXI-5001 in adult participants with advanced malignancies who have previously failed other therapies. The study has two phases. The purpose of Phase I (Dose Escalation) is to confirm the appropriate treatment dose and Phase II (Dose Expansion) is to characterize the safety and efficacy of AMXI-5001.

Clinical Trial Description

AMXI-5001 is an orally available dual PARP (poly adenosine diphosphate [ADP] ribose polymerase) and microtubule polymerization inhibitor. ATLAS-101 is a Phase I/II, open label, multi-center, non-randomized Dose Escalation and Dose Expansion study in participants with advanced malignancies. Study enrollment is approximately 122 participants. All participants receive oral AMXI-5001, twice daily, as monotherapy. Following Phase I (Dose Escalation) to identify the Maximum Tolerated Dose and the Recommended Dose for use in Phase II, additional participants will be enrolled into the Dose Expansion Phase to further characterize the safety, pharmacology, and clinical efficacy of AMXI-5001. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04503265
Study type	Interventional
Source	AtlasMedx, Incorporated
Contact
Status	Active, not recruiting
Phase	Phase 1/Phase 2
Start date	August 12, 2020
Completion date	January 2025

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