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 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.

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

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 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.

Detailed Description

      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.
    

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

        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 dose-limiting toxicity (DLT)
Time Frame:Approximately 12 months
Safety Issue:
Description:Determine the DLT of AMXI-5001 (in milligrams)

Secondary Outcome Measures

Measure:Determine Duration of Response (DOR)
Time Frame:Approximately 24 months
Safety Issue:
Description:Determine DOR as the time from documentation of tumor response to disease progression.
Measure:Determine Progression-free Survival (PFS)
Time Frame:Approximately 24 months
Safety Issue:
Description:Determine PFS as the time from study enrollment until objective tumor progression or death.
Measure:Determine Overall Survival (OS)
Time Frame:Approximately 24 months
Safety Issue:
Description:Determine OS as the time from study entry to death from any cause.
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 will be calculated.
Measure:Characterize safety profile of AMXI-5001
Time Frame:Approximately 24 months
Safety Issue:
Description:Characterize the safety profile of AMXI-5001 by incidence of treatment emergent adverse events, standard hematologic, chemistry, and ECG measurements.

Details

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

Trial Keywords

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

Last Updated

August 4, 2020