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/NCT05983367</url>
    </required_header>
    <id_info>
      <org_study_id>RGX-202-002</org_study_id>
      <nct_id>NCT05983367</nct_id>
    </id_info>
    <brief_title>A Study to Investigate Response to Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Patients With Advanced or Metastatic Colorectal Cancer</brief_title>
    <official_title>A Randomized Phase 2 Study of Ompenaclid Versus Placebo in Combination With FOLFIRI Plus Bevacizumab in Patients With Previously Treated RAS Mutant Advanced or Metastatic Colorectal Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Inspirna, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Inspirna, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to measure tumor response to treatment with ompenaclid (RGX-202)&#xD;
        in patients with previously treated RAS mutant advanced or metastatic CRC. All patients will&#xD;
        receive treatment with FOLFIRI and bevacizumab. In addition, patients will be randomized to&#xD;
        receive either ompenaclid 3000 mg BID or matching placebo (herein referred to as Study Drug).&#xD;
        Each treatment cycle is 28 days in duration.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2028</completion_date>
    <primary_completion_date type="Anticipated">August 2026</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>randomized 1:1</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Overall Response Rate</measure>
      <time_frame>36 months</time_frame>
      <description>The primary objective is to demonstrate that ompenaclid (RGX-202) is superior to placebo in achieving CR or PR (determined as ORR).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall Survival</measure>
      <time_frame>36 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response</measure>
      <time_frame>36 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate</measure>
      <time_frame>36 months</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Colorectal Cancer</condition>
    <condition>Metastatic Colon Cancer</condition>
    <arm_group>
      <arm_group_label>RGX-202-01 + FOLFIRI + Bevacizumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo + + FOLFIRI + Bevacizumab</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ompenaclid (RGX-202)</intervention_name>
      <description>RGX-202</description>
      <arm_group_label>RGX-202-01 + FOLFIRI + Bevacizumab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo</description>
      <arm_group_label>Placebo + + FOLFIRI + Bevacizumab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bevacizumab</intervention_name>
      <description>Bevacizumab</description>
      <arm_group_label>Placebo + + FOLFIRI + Bevacizumab</arm_group_label>
      <arm_group_label>RGX-202-01 + FOLFIRI + Bevacizumab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>FOLFOX regimen</intervention_name>
      <description>FOLFOX regimen ( Leucovorin Calcium (Folinic Acid); Fluorouracil, Oxaliplatin )</description>
      <arm_group_label>Placebo + + FOLFIRI + Bevacizumab</arm_group_label>
      <arm_group_label>RGX-202-01 + FOLFIRI + Bevacizumab</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Advanced disease, defined as cancer that is either metastatic or locally advanced and&#xD;
               unresectable and for which additional radiation therapy or other locoregional&#xD;
               therapies are not considered feasible.&#xD;
  &#xD;
            2. Progression of disease after receiving only 1 prior regimen considered standard of&#xD;
               care for CRC in the advanced/metastatic setting, and it must have been an&#xD;
               oxaliplatin-containing regimen. Patients who have dMMR/MSI-H CRC must have also&#xD;
               received prior treatment with pembrolizumab or an FDA/EU-approved PD-1/PD-L1&#xD;
               inhibitor. Patients may have received prior treatment with bevacizumab or an&#xD;
               EMA-approved biosimilar. Patients who developed metastatic CRC within 12 months of&#xD;
               completion of adjuvant oxaliplatin and 5-FU based therapy are also eligible as long as&#xD;
               they did not receive an additional first line regimen in the advanced/metastatic&#xD;
               setting.&#xD;
  &#xD;
            3. Histologic or cytologic evidence of a malignant colorectal tumor of adenocarcinoma or&#xD;
               poorly differentiated histology that is laboratory-confirmed to be RAS mutant.&#xD;
               Confirmation of RAS mutant status by liquid biopsy is acceptable only if the tumor&#xD;
               sample is not available and the liquid biopsy was performed before initiation of the&#xD;
               patient's prior treatment regimen.&#xD;
  &#xD;
            4. Disease that is measurable by standard imaging techniques by RECIST version 1.1. For&#xD;
               patients with prior radiation therapy, measurable lesions must be outside of any prior&#xD;
               radiation field(s), unless disease progression has been documented at that disease&#xD;
               site subsequent to radiation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Persistent clinically significant toxicities (Grade ≥2) from previous anticancer therapy.&#xD;
  &#xD;
          Excluded are Grade 2 chemotherapy-related neuropathy and alopecia which are permitted and&#xD;
          Grade 2 laboratory abnormalities if they are not associated with symptoms, are not&#xD;
          considered clinically significant by the Investigator, or can be managed with available&#xD;
          medical therapies.&#xD;
  &#xD;
          2. CRC with histology (or component of histology) consistent with small cell,&#xD;
          neuroendocrine, or squamous carcinoma, or lymphoma.&#xD;
  &#xD;
          3. Received treatment with chemotherapy, external-beam radiation, or other systemic&#xD;
          anticancer therapy within 14 days prior to study therapy administration (42 days for prior&#xD;
          nitrosourea or mitomycin-C).&#xD;
  &#xD;
          4. Received treatment with an investigational systemic anticancer agent within 5 half-lives&#xD;
          of the investigational systemic therapy or within 28 days, whichever is shorter prior to&#xD;
          Study Drug administration.&#xD;
  &#xD;
          5. Has an additional active malignancy that may confound the assessment of the study&#xD;
          endpoints. Patients with a past cancer history with substantial potential for recurrence&#xD;
          must be discussed with the Medical Monitor before study entry. Patients with the following&#xD;
          concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ&#xD;
          (including transitional cell carcinoma, cervical intraepithelial neoplasia, and melanoma in&#xD;
          situ), organ-confined prostate cancer with no evidence of progressive disease.&#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 Wasserman, MD</last_name>
      <role>Study Director</role>
      <affiliation>CMO</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Stephen Kaesshaefer</last_name>
      <phone>9737152917</phone>
      <email>steve.kaesshaefer@inspirna.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Imelda Ziekenhuis</name>
        <address>
          <city>Bonheiden</city>
          <state>Antwerpen</state>
          <zip>2820</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Pieter-Jan Cuyle, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc</name>
        <address>
          <city>Woluwe-Saint-Lambert</city>
          <state>Brussels Capital Region</state>
          <zip>1200</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Marc Van den Eynde, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>CHU Nantes -hopital hotel Dieu</name>
        <address>
          <city>Nantes</city>
          <state>Loire-Atlantique</state>
          <zip>44093</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Dahna Coupez, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Groupe Hospitalier Paris Saint Joseph - Oncologie</name>
        <address>
          <city>Paris</city>
          <zip>75074</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Eric Raymond, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hospital Universitario Marqués de Valdecilla</name>
        <address>
          <city>Santander</city>
          <state>Cantabria</state>
          <zip>39008</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Fernando Rivera Herrero, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hospital de la Santa Creu i Sant Pau</name>
        <address>
          <city>Barcelona</city>
          <state>Cataluna</state>
          <zip>08025</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>David Paez Lopez-Bravo</last_name>
        <email>DPaez@santpau.cat</email>
      </contact>
      <investigator>
        <last_name>David Paez Lopez-Bravo, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hospital Universitari Vall D Hebron</name>
        <address>
          <city>Barcelona</city>
          <zip>08035</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Maria Elena Elez Fernández, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hospital Clinico Universitario De Valencia</name>
        <address>
          <city>Valencia</city>
          <zip>46010</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Susana Roselló Keränen</last_name>
        <email>srosello@incliva.es</email>
      </contact>
      <investigator>
        <last_name>Susana Roselló Keränen, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Belgium</country>
      <country>France</country>
      <country>Spain</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Metastatic colon cancer</keyword>
    <keyword>KRAS colon cancer</keyword>
    <keyword>CRC advance cancer</keyword>
    <keyword>malignant colorectal tumor</keyword>
    <keyword>RAS mutant colon cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
      <mesh_term>Colonic Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bevacizumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT05983367
  org study id: RGX-202-002
  nct id: NCT05983367
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The purpose of this study is to measure tumor response to treatment with ompenaclid (RGX-202)
        in patients with previously treated RAS mutant advanced or metastatic CRC. All patients will
        receive treatment with FOLFIRI and bevacizumab. In addition, patients will be randomized to
        receive either ompenaclid 3000 mg BID or matching placebo (herein referred to as Study Drug).
        Each treatment cycle is 28 days in duration.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: randomized 1:1
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Overall Response Rate
  time frame: 36 months
  description: The primary objective is to demonstrate that ompenaclid (RGX-202) is superior to placebo in achieving CR or PR (determined as ORR).
  measure: Overall Survival
  time frame: 36 months
  measure: Duration of Response
  time frame: 36 months
  measure: Disease Control Rate
  time frame: 36 months
  arm group label: RGX-202-01 + FOLFIRI + Bevacizumab
  arm group type: Experimental
  description: Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
  arm group label: Placebo + + FOLFIRI + Bevacizumab
  arm group type: Placebo Comparator
  description: Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
  intervention type: Drug
  intervention name: Ompenaclid (RGX-202)
  description: RGX-202
  arm group label: RGX-202-01 + FOLFIRI + Bevacizumab
  intervention type: Drug
  intervention name: Placebo
  description: Placebo
  arm group label: Placebo + + FOLFIRI + Bevacizumab
  intervention type: Drug
  intervention name: Bevacizumab
  description: Bevacizumab
  arm group label: Placebo + + FOLFIRI + Bevacizumab
  arm group label: RGX-202-01 + FOLFIRI + Bevacizumab
  intervention type: Drug
  intervention name: FOLFOX regimen
  description: FOLFOX regimen ( Leucovorin Calcium (Folinic Acid); Fluorouracil, Oxaliplatin )
  arm group label: Placebo + + FOLFIRI + Bevacizumab
  arm group label: RGX-202-01 + FOLFIRI + Bevacizumab
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Robert Wasserman, MD
  role: Study Director
  affiliation: CMO
  last name: Stephen Kaesshaefer
  phone: 9737152917
  email: steve.kaesshaefer@inspirna.com
  facility: 
  status: Not yet recruiting
  investigator: 
  facility: 
  status: Not yet recruiting
  investigator: 
  facility: 
  status: Not yet recruiting
  investigator: 
  facility: 
  status: Not yet recruiting
  investigator: 
  facility: 
  status: Not yet recruiting
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Not yet recruiting
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Belgium
  country: France
  country: Spain
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms
  mesh term: Colonic Neoplasms
  mesh term: Bevacizumab
  sharing ipd: Undecided