Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

ATLAS-101 is a Phase I/II clinical trial of AMXI-5001 in 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. The purpose of Phase II (dose expansion) is to characterize the safety and efficacy of AMXI-5001.

Official Title

A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies

Details

AMXI-5001 is a 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 80 participants. Participants receive oral AMXI-5001, twice daily, as monotherapy. The Dose Escalation Phase is a standard 3+3 escalation scheme. Following the identification of the Maximum Tolerated Dose in Phase I 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.

Keywords

Advanced Malignant Neoplasm Breast Cancer Ovarian Cancer Homologous Recombination Deficiency Breast Ovarian Refractory Cancer Malignancy BRCA HRD AMXI-5001 Progression PARP Inhibitor Microtubule inhibitor Neoplasms AMXI-5001:Dose Escalation Phase I AMXI-5001: Dose Expansion Phase II

Eligibility

You can join if…

Open to people ages 18 years and up

(Key Factors):

  1. Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
  2. Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
  3. Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
  4. Malignancy has progressed after standard therapy
  5. Has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
  6. Eastern Co-operative Oncology Group (ECOG) PS 0-1

You CAN'T join if...

(Key Factors):

  1. Receiving cancer treatment at the time of enrollment
  2. Any clinically significant disease or condition affecting a major organ system
  3. Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
  4. Use of a strong inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy and throughout the study (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit)
  5. Has had a previous (within 2 years) or has a current malignancy other than the target cancer

Locations

  • UCLA Department of Medicine - Hematology/Oncology accepting new patients
    Los Angeles California 90404 United States
  • The Sarah Cannon Research Institute/Tennessee Oncology accepting new patients
    Nashville Tennessee 37203 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AtlasMedx, Incorporated
ID
NCT04503265
Phase
Phase 1/2
Study Type
Interventional
Last Updated