681TiP - A phase I/II, open label, multi-center, non-randomized dose escalation and dose expansion study of AMXI-5001 in patients with advanced malignancies

Background

AMXI-5001 is a novel, first-in-class, orally bioavailable dual-action PARP/microtubule small-molecule inhibitor. It has shown anti-tumor activity in multiple preclinical models. This study is an open-label, multi-center, non-randomized dose escalation study of AMXI-5001 as monotherapy in patients with refractory advanced malignancies with a dose expansion in patients with HRD mutations.

Trial design

AMXI-5001 is administered orally twice daily (BID) on a continuous 7-day dosing regimen in the dose escalation phase. The primary endpoints are assessing safety, tolerability, pharmacokinetics (PK), determining the maximum tolerated dose (MTD), and recommended Phase2 dose (RP2D). The secondary endpoint is preliminary efficacy. The dose-limiting toxicity (DLT) will be assessed during Cycle 1 treatment. Once the RP2D is defined, the trial will advance into two phase 2 expansion basket cohorts: Cohort 1 will include patients with Homologous recombination deficiency (HRD) mutations with no prior PARP inhibitor treatment. Cohort 2 will include BRCA1 and BRCA2 mutated patients who progressed on prior PARP inhibitors. The dose expansion phase's primary endpoint is the preliminary efficacy. The secondary endpoint is to characterize the safety and tolerability further.

Clinical trial identification

NCT04503265, ATLAS-101.

Editorial acknowledgement

We acknowledge Clinical Resource Solutions staff for their assistance in the development of this abstract.

Legal entity responsible for the study

AtlasMedx, Incorporated.

Funding

AtlasMedx, Incorporated.

Disclosure

R. Costa: Other, Personal, Speaker, Consultant, Advisor, Honoraria: Pfizer, Daiichi Sankyo, Astra Zenaka, Athenex Oncology; Non-Financial Interests, Personal, Speaker, Consultant, Advisor: Gilead. H. Alaoui: Financial Interests, Personal and Institutional, Officer, stock ownership: AtlasMedx,Inc. D.M. Jablons: Financial Interests, Personal, Advisory Board: AtlasMedx,Inc. P. Munster: Financial Interests, Personal, Advisory Role: AtlasMedx,Inc. All other authors have declared no conflicts of interest.