<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04503265</url>
  </required_header>
  <id_info>
    <org_study_id>ATLAS-101</org_study_id>
    <nct_id>NCT04503265</nct_id>
  </id_info>
  <brief_title>A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AtlasMedx, Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AtlasMedx, Incorporated</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      ATLAS-101 is a Phase I/II clinical trial of AMXI-5001 in adult participants with advanced&#xD;
      malignancies who have previously failed other therapies. The study has two phases. The&#xD;
      purpose of Phase I (Dose Escalation) is to confirm the appropriate treatment dose and Phase&#xD;
      II (Dose Expansion) is to characterize the safety and efficacy of AMXI-5001.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      AMXI-5001 is an orally available dual PARP (poly adenosine diphosphate [ADP] ribose&#xD;
      polymerase) and microtubule polymerization inhibitor. ATLAS-101 is a Phase I/II, open label,&#xD;
      multi-center, non-randomized Dose Escalation and Dose Expansion study in participants with&#xD;
      advanced malignancies. Study enrollment is approximately 122 participants. All participants&#xD;
      receive oral AMXI-5001, twice daily, as monotherapy. Following Phase I (Dose Escalation) to&#xD;
      identify the Maximum Tolerated Dose and the Recommended Dose for use in Phase II, additional&#xD;
      participants will be enrolled into the Dose Expansion Phase to further characterize the&#xD;
      safety, pharmacology, and clinical efficacy of AMXI-5001.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 12, 2020</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determine the Maximum Tolerated Dose (MTD)</measure>
    <time_frame>Approximately 12 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapy</measure>
    <time_frame>Approximately 12 months</time_frame>
    <description>The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure concentration of AMXI-5001 in plasma samples</measure>
    <time_frame>Approximately 24 months</time_frame>
    <description>Concentrations of AMXI-5001 in plasma samples at different time points are measured. Standard pharmacokinetic parameters are calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterize safety profile of AMXI-5001</measure>
    <time_frame>Approximately 24 months</time_frame>
    <description>The safety profile of AMXI-5001 is defined by the incidence of treatment emergent adverse events, laboratory abnormalities, and ECG measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine change in anti-tumor activity following administration of AMXI-5001</measure>
    <time_frame>Approximately 24 months</time_frame>
    <description>Overall Survival (OS), Objective Response Rate (ORR), Duration of Response (DOR), and Progression-free Survival (PFS) are assessed by RECIST V1.1 criteria.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">122</enrollment>
  <condition>Advanced Malignant Neoplasm</condition>
  <condition>Breast Cancer</condition>
  <condition>Ovarian Cancer</condition>
  <condition>Homologous Recombination Deficiency</condition>
  <condition>Prostate Cancer</condition>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>AMXI-5001 Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Arm Study, all participants will receive AMXI-5001.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AMXI-5001:Dose Escalation Phase I</intervention_name>
    <description>Phase I will enroll up to 70 participants to identify the Recommended Phase II daily dose in the treatment of various cancers and to characterize the safety, pharmacology, and clinical efficacy of AMXI-5001. AMXI-5001 is administered orally twice daily, with food. AMXI-5001 is administered weekly on a continuous 7-day schedule. Each cycle is 28 days.</description>
    <arm_group_label>AMXI-5001 Treatment</arm_group_label>
    <other_name>Phase I</other_name>
    <other_name>Dose Escalation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AMXI-5001:Dose Expansion Phase II</intervention_name>
    <description>Phase II will enroll up to 52 study participants to further characterize the safety, pharmacology, and clinical efficacy of AMXI-5001. AMXI-5001 is administered orally twice daily, with food. AMXI-5001 is administered weekly on a continuous 7-day schedule. Each cycle is 28 days.</description>
    <arm_group_label>AMXI-5001 Treatment</arm_group_label>
    <other_name>Phase II</other_name>
    <other_name>Dose Expansion</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (Key Factors):&#xD;
&#xD;
          1. Has pathologically confirmed advanced or metastatic malignancy characterized by one or&#xD;
             more of the following:&#xD;
&#xD;
               1. Patient is intolerant of existing therapy(ies) known to provide clinical benefit&#xD;
                  for their condition&#xD;
&#xD;
               2. Malignancy is refractory to existing therapy(ies) known to potentially provide&#xD;
                  clinical benefit&#xD;
&#xD;
               3. Malignancy has progressed after standard therapy&#xD;
&#xD;
          2. Has evaluable or measurable tumor(s) in dose escalation by standard radiological&#xD;
             and/or laboratory assessments as applicable to their malignancy.&#xD;
&#xD;
          3. Eastern Co-operative Oncology Group (ECOG) PS 0-1&#xD;
&#xD;
          4. Participant must be 18 years of age or older&#xD;
&#xD;
        Exclusion Criteria (Key Factors):&#xD;
&#xD;
          1. Receiving cancer treatment at the time of enrollment&#xD;
&#xD;
          2. Any clinically significant disease or condition affecting a major organ system&#xD;
&#xD;
          3. Significant cardiovascular disease or electrocardiogram (ECG) abnormalities&#xD;
&#xD;
          4. Use of a strong inhibitor or inducer of CYP3A4 within 7 days prior to start of study&#xD;
             therapy and throughout the study (e.g., some antibiotics, antifungals,&#xD;
             anticonvulsants, grapefruit)&#xD;
&#xD;
          5. Has had a previous (within 2 years) or has a current malignancy other than the target&#xD;
             cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Reder, MD</last_name>
    <role>Study Director</role>
    <affiliation>AtlasMedx, Inc</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bonnie Wettersten, MS</last_name>
    <phone>(847) 644-9818</phone>
    <email>clinicaltrials@atlasmedx.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Honor Health</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85374</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of California, Davis (UC Davis)</name>
      <address>
        <city>Davis</city>
        <state>California</state>
        <zip>95616</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center and Research Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Sarah Cannon Research Institute/Tennessee Oncology</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37235</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>The University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/32905466/</url>
    <description>Citation</description>
  </link>
  <reference>
    <citation>Lemjabbar-Alaoui H, Peto CJ, Yang YW, Jablons DM. AMXI-5001, a novel dual parp1/2 and microtubule polymerization inhibitor for the treatment of human cancers. Am J Cancer Res. 2020 Aug 1;10(8):2649-2676. eCollection 2020.</citation>
    <PMID>32905466</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast</keyword>
  <keyword>Ovarian</keyword>
  <keyword>Prostate</keyword>
  <keyword>Pancreatic</keyword>
  <keyword>Refractory</keyword>
  <keyword>Cancer</keyword>
  <keyword>Malignancy</keyword>
  <keyword>BRCA</keyword>
  <keyword>HRD</keyword>
  <keyword>AMXI-5001</keyword>
  <keyword>Progression</keyword>
  <keyword>PARP Inhibitor</keyword>
  <keyword>Microtubule inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04503265
org study id: ATLAS-101
nct id: NCT04503265
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Determine the Maximum Tolerated Dose (MTD)
time frame: Approximately 12 months
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.
measure: Determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapy
time frame: Approximately 12 months
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
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
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
description: Overall Survival (OS), Objective Response Rate (ORR), Duration of Response (DOR), and Progression-free Survival (PFS) are assessed by RECIST V1.1 criteria.
arm group label: AMXI-5001 Treatment
arm group type: Experimental
description: Single Arm Study, all participants will receive AMXI-5001.
intervention type: Drug
intervention name: AMXI-5001:Dose Escalation Phase I
description: Phase I will enroll up to 70 participants to identify the Recommended Phase II daily dose in the treatment of various cancers and to characterize the safety, pharmacology, and clinical efficacy of AMXI-5001. AMXI-5001 is administered orally twice daily, with food. AMXI-5001 is administered weekly on a continuous 7-day schedule. Each cycle is 28 days.
arm group label: AMXI-5001 Treatment
other name: Phase I
other name: Dose Escalation
intervention type: Drug
intervention name: AMXI-5001:Dose Expansion Phase II
description: Phase II will enroll up to 52 study participants to further characterize the safety, pharmacology, and clinical efficacy of AMXI-5001. AMXI-5001 is administered orally twice daily, with food. AMXI-5001 is administered weekly on a continuous 7-day schedule. Each cycle is 28 days.
arm group label: AMXI-5001 Treatment
other name: Phase II
other name: Dose Expansion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Reder, MD
role: Study Director
affiliation: AtlasMedx, Inc
last name: Bonnie Wettersten, MS
phone: (847) 644-9818
email: clinicaltrials@atlasmedx.com
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
country: United States
url: https://pubmed.ncbi.nlm.nih.gov/32905466/
description: Citation
citation: Lemjabbar-Alaoui H, Peto CJ, Yang YW, Jablons DM. AMXI-5001, a novel dual parp1/2 and microtubule polymerization inhibitor for the treatment of human cancers. Am J Cancer Res. 2020 Aug 1;10(8):2649-2676. eCollection 2020.
PMID: 32905466
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No