xml: <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/NCT05997615</url>
    </required_header>
    <id_info>
      <org_study_id>TCD17896</org_study_id>
      <secondary_id>U1111-1287-6968</secondary_id>
      <secondary_id>AMX-500-001</secondary_id>
      <nct_id>NCT05997615</nct_id>
    </id_info>
    <brief_title>Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Metastatic Castration Resistant Prostate Cancer (mCRPC)</brief_title>
    <official_title>A Phase 1, First-in-human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Amunix, a Sanofi Company</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sanofi</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study will be conducted in 4 parts and will commence with dose escalation of AMX-500 as a&#xD;
        monotherapy (Part 1), followed by monotherapy dose expansion (Part 2).&#xD;
  &#xD;
          -  Part 1 (Monotherapy Dose Escalation): Single-agent AMX-500 dose escalation&#xD;
  &#xD;
          -  Part 2 (Monotherapy Dose Expansion): Single-agent AMX-500 dose expansion&#xD;
  &#xD;
        The study may subsequently continue via a protocol amendment with dose escalation of AMX-500&#xD;
        combinations (Part 3) followed by combination therapy dose expansion (Part 4).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Duration of the study up to approximately 48 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 29, 2023</start_date>
    <completion_date type="Anticipated">September 29, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 29, 2027</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>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Part 1: Number of participants with Adverse Events (AEs)</measure>
      <time_frame>from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months</time_frame>
      <description>Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Part 1: Incidence of Dose Limiting Toxicities (DLTs)</measure>
      <time_frame>from the Cycle 1(each cycle is 21 days), Day 1 up to Day 21</time_frame>
      <description>Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Part 2: Prostate-Specific Antigen (PSA) response rate</measure>
      <time_frame>from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months</time_frame>
      <description>defined as a ≥ 50% reduction in PSA from baseline</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Part 2: Objective Response Rate (ORR)</measure>
      <time_frame>from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months</time_frame>
      <description>defined as the proportion of participants who have a complete response (CR) or partial response (PR) determined per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Part 2: Number of participants with Adverse Events (AEs)</measure>
      <time_frame>from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part 1: PSA response rate</measure>
      <time_frame>from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part 1: Objective Response Rate (ORR)</measure>
      <time_frame>from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All parts: Time to Response</measure>
      <time_frame>from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months</time_frame>
      <description>Time from the start of treatment to the first objective tumor response observed for participants who achieved confirmed Complete Response or Partial Response</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All parts: Duration of response (DoR)</measure>
      <time_frame>from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months</time_frame>
      <description>DOR defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST v.1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All parts: Progression Free Survival PFS</measure>
      <time_frame>from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months</time_frame>
      <description>Time from treatment initiation to disease progression using RECIST v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All parts: Assessment of PK parameters: Cmax</measure>
      <time_frame>from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months</time_frame>
      <description>Maximum plasma concentration observed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All parts: Assessment of PK parameters: AUC</measure>
      <time_frame>from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months</time_frame>
      <description>Area under the concentration versus time curve</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All parts: Assessment of PK parameters: Tmax</measure>
      <time_frame>from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months</time_frame>
      <description>Time to reach Cmax</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All parts: Incidence of baseline anti-drug antibodies (ADAs) to AMX-500</measure>
      <time_frame>from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months</time_frame>
      <description>Incidence of patients with baseline anti-drug antibodies to AMX-500</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All parts: Incidence of treatment emergent anti-drug antibodies (ADAs) to AMX-500</measure>
      <time_frame>from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months</time_frame>
      <description>Incidence of patients with treatment emergent anti-drug antibodies to AMX-500</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">215</enrollment>
    <condition>Hormone-refractory Prostate Cancer</condition>
    <arm_group>
      <arm_group_label>Part 1: AMX-500 Monotherapy Dose Escalation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>AMX-500 will be administered as a monotherapy in patients with mCRPC over a 21-day cycle</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2: AMX-500 Monotherapy Dose Expansion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>AMX-500 will be administered as a monotherapy in patients with mCRPC over a 21-day cycle</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>AMX-500 (SAR446329)</intervention_name>
      <description>Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion</description>
      <arm_group_label>Part 1: AMX-500 Monotherapy Dose Escalation</arm_group_label>
      <arm_group_label>Part 2: AMX-500 Monotherapy Dose Expansion</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Has histological, pathological, and/or cytological confirmation of prostate&#xD;
               adenocarcinoma OR metastatic disease typical of prostate cancer (ie, involving bone or&#xD;
               pelvic lymph nodes or para-aortic lymph nodes)&#xD;
  &#xD;
            -  Has metastatic disease, defined by ≥1 metastatic lesion that is present on baseline&#xD;
               CT, MRI, or bone scan imaging - Has documented progressive mCRPC&#xD;
  &#xD;
            -  Have been treated with ≥ 1 prior taxane regimens (eg, docetaxel, cabazitaxel)&#xD;
  &#xD;
            -  Participants deemed unsuitable for standard of care&#xD;
  &#xD;
            -  Has Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2&#xD;
  &#xD;
            -  Has a life expectancy more than 6 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of dominant histopathological features representative of sarcomatoid, spindle&#xD;
               cell, or neuroendocrine small cell components&#xD;
  &#xD;
            -  Has acute or chronic infections&#xD;
  &#xD;
            -  Has a concomitant medical or inflammatory condition that may increase the risk of&#xD;
               toxicity to AMX 500, per the Investigator&#xD;
  &#xD;
            -  Has lesions in proximity of vital organs&#xD;
  &#xD;
            -  Has known active CNS metastases and/or carcinomatous meningitis The above information&#xD;
               is not intended to contain all considerations relevant to a patient's potential&#xD;
               participation in a clinical trial.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Clinical Sciences &amp;amp; Operations</last_name>
      <role>Study Director</role>
      <affiliation>Sanofi</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Trial Transparency email recommended (Toll free for US &amp;amp; Canada)</last_name>
      <phone>800-633-1610</phone>
      <phone_ext>option 6</phone_ext>
      <email>Contact-US@sanofi.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Investigational site number #100</name>
        <address>
          <city>Melbourne</city>
          <zip>3000</zip>
          <country>Australia</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Australia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Prostate Cancer</keyword>
    <keyword>Metastatic Castration-resistant Prostate Cancer</keyword>
    <keyword>Castration Resistant Prostatic Cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatic Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997615
  org study id: TCD17896
  secondary id: U1111-1287-6968
  secondary id: AMX-500-001
  nct id: NCT05997615
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study will be conducted in 4 parts and will commence with dose escalation of AMX-500 as a
        monotherapy (Part 1), followed by monotherapy dose expansion (Part 2).
  
          -  Part 1 (Monotherapy Dose Escalation): Single-agent AMX-500 dose escalation
  
          -  Part 2 (Monotherapy Dose Expansion): Single-agent AMX-500 dose expansion
  
        The study may subsequently continue via a protocol amendment with dose escalation of AMX-500
        combinations (Part 3) followed by combination therapy dose expansion (Part 4).
  Duration of the study up to approximately 48 months.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Part 1: Number of participants with Adverse Events (AEs)
  time frame: from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
  description: Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
  measure: Part 1: Incidence of Dose Limiting Toxicities (DLTs)
  time frame: from the Cycle 1(each cycle is 21 days), Day 1 up to Day 21
  description: Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
  measure: Part 2: Prostate-Specific Antigen (PSA) response rate
  time frame: from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
  description: defined as a ≥ 50% reduction in PSA from baseline
  measure: Part 2: Objective Response Rate (ORR)
  time frame: from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
  description: defined as the proportion of participants who have a complete response (CR) or partial response (PR) determined per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
  measure: Part 2: Number of participants with Adverse Events (AEs)
  time frame: from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
  measure: Part 1: PSA response rate
  time frame: from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
  measure: Part 1: Objective Response Rate (ORR)
  time frame: from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
  measure: All parts: Time to Response
  time frame: from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
  description: Time from the start of treatment to the first objective tumor response observed for participants who achieved confirmed Complete Response or Partial Response
  measure: All parts: Duration of response (DoR)
  time frame: from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
  description: DOR defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST v.1.1.
  measure: All parts: Progression Free Survival PFS
  time frame: from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
  description: Time from treatment initiation to disease progression using RECIST v1.1
  measure: All parts: Assessment of PK parameters: Cmax
  time frame: from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
  description: Maximum plasma concentration observed
  measure: All parts: Assessment of PK parameters: AUC
  time frame: from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
  description: Area under the concentration versus time curve
  measure: All parts: Assessment of PK parameters: Tmax
  time frame: from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
  description: Time to reach Cmax
  measure: All parts: Incidence of baseline anti-drug antibodies (ADAs) to AMX-500
  time frame: from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
  description: Incidence of patients with baseline anti-drug antibodies to AMX-500
  measure: All parts: Incidence of treatment emergent anti-drug antibodies (ADAs) to AMX-500
  time frame: from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
  description: Incidence of patients with treatment emergent anti-drug antibodies to AMX-500
  arm group label: Part 1: AMX-500 Monotherapy Dose Escalation
  arm group type: Experimental
  description: AMX-500 will be administered as a monotherapy in patients with mCRPC over a 21-day cycle
  arm group label: Part 2: AMX-500 Monotherapy Dose Expansion
  arm group type: Experimental
  description: AMX-500 will be administered as a monotherapy in patients with mCRPC over a 21-day cycle
  intervention type: Drug
  intervention name: AMX-500 (SAR446329)
  description: Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion
  arm group label: Part 1: AMX-500 Monotherapy Dose Escalation
  arm group label: Part 2: AMX-500 Monotherapy Dose Expansion
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clinical Sciences &amp; Operations
  role: Study Director
  affiliation: Sanofi
  last name: Trial Transparency email recommended (Toll free for US &amp; Canada)
  phone: 800-633-1610
  phone ext: option 6
  email: Contact-US@sanofi.com
  facility: 
  status: Recruiting
  country: Australia
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  sharing ipd: Yes
  ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org