Clinical Trials /

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

NCT04503265

Description:

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.

Related Conditions:
  • Cancer
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
  • 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

Clinical Trial IDs

  • ORG STUDY ID: ATLAS-101
  • NCT ID: NCT04503265

Conditions

  • Advanced Malignant Neoplasm
  • Breast Cancer
  • Ovarian Cancer
  • Homologous Recombination Deficiency
  • Prostate Cancer
  • Pancreatic Cancer

Interventions

DrugSynonymsArms
AMXI-5001:Dose Escalation Phase IPhase I, Dose EscalationAMXI-5001 Treatment
AMXI-5001:Dose Expansion Phase IIPhase II, Dose ExpansionAMXI-5001 Treatment

Purpose

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.

Detailed 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 82 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.
    

Trial Arms

NameTypeDescriptionInterventions
AMXI-5001 TreatmentExperimentalSingle Arm Study, all participants will receive AMXI-5001.
  • AMXI-5001:Dose Escalation Phase I
  • AMXI-5001:Dose Expansion Phase II

Eligibility Criteria

        Inclusion Criteria (Key Factors):

          1. Has pathologically confirmed advanced or metastatic malignancy characterized by one or
             more of the following:

               1. Patient is intolerant of existing therapy(ies) known to provide clinical benefit
                  for their condition

               2. Malignancy is refractory to existing therapy(ies) known to potentially provide
                  clinical benefit

               3. Malignancy has progressed after standard therapy

          2. Has evaluable or measurable tumor(s) in dose escalation by standard radiological
             and/or laboratory assessments as applicable to their malignancy.

          3. Eastern Co-operative Oncology Group (ECOG) PS 0-1

          4. Participant must be 18 years of age or older

        Exclusion Criteria (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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Determine the Maximum Tolerated Dose (MTD)
Time Frame:Approximately 12 months
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapy
Time Frame:Approximately 12 months
Safety Issue:
Description:The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.
Measure:Measure concentration of AMXI-5001 in plasma samples
Time Frame:Approximately 24 months
Safety Issue:
Description:Concentrations of AMXI-5001 in plasma samples at different time points are measured. Standard pharmacokinetic parameters are calculated.
Measure:Characterize safety profile of AMXI-5001
Time Frame:Approximately 24 months
Safety Issue:
Description:The safety profile of AMXI-5001 is defined by the incidence of treatment emergent adverse events, laboratory abnormalities, and ECG measurements.
Measure:Determine change in anti-tumor activity following administration of AMXI-5001
Time Frame:Approximately 24 months
Safety Issue:
Description:Overall Survival (OS), Objective Response Rate (ORR), Duration of Response (DOR), and Progression-free Survival (PFS) are assessed by RECIST V1.1 criteria.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AtlasMedx, Incorporated

Trial Keywords

  • Breast
  • Ovarian
  • Prostate
  • Pancreatic
  • Refractory
  • Cancer
  • Malignancy
  • BRCA
  • HRD
  • AMXI-5001
  • Progression
  • PARP Inhibitor
  • Microtubule inhibitor

Last Updated

February 25, 2021