<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/NCT04497116</url>
  </required_header>
  <id_info>
    <org_study_id>RP-3500-01</org_study_id>
    <secondary_id>2020-000301-87</secondary_id>
    <nct_id>NCT04497116</nct_id>
  </id_info>
  <brief_title>Study of RP-3500, Camonsertib, in Advanced Solid Tumors</brief_title>
  <official_title>Phase 1/2a Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-3500 Alone or in Combination With Talazoparib or Gemcitabine in Advanced Solid Tumors With ATR Inhibitor Sensitizing Mutations (TRESR Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Repare Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Repare Therapeutics</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to define the maximum tolerated dose (MTD) and determine&#xD;
      a recommended Phase 2 dose (RP2D) and schedule of orally-administered RP-3500 (camonsertib)&#xD;
      alone or in combination with talazoparib, a PARP inhibitor, or Gemcitabine in patients with&#xD;
      advanced solid tumors with ATR inhibitor-sensitizing mutations. This study will also evaluate&#xD;
      the safety and tolerability of RP-3500 (camonsertib) alone or in combination with talazoparib&#xD;
      or gemcitabine, examine both the pharmacokinetics (PK)and pharmacodynamics (PD)and&#xD;
      investigate its anti-tumor activity in solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a first-in-human, Phase 1/2a, multi-center, open-label, dose-escalation and expansion&#xD;
      study to:&#xD;
&#xD;
        -  Evaluate the safety profile and MTD of RP-3500 (camonsertib) when administered orally,&#xD;
           alone and in combination with talazoparib or gemcitabine, to establish the dose and&#xD;
           schedule recommended for the Phase 2&#xD;
&#xD;
        -  Characterize the PK profile of RP-3500 (camonsertib) alone or in combination with&#xD;
           talazoparib or gemcitabine&#xD;
&#xD;
        -  Identify anti-tumor activity associated with RP-3500 (camonsertib) given alone or in&#xD;
           combination with talazoparib or gemcitabine&#xD;
&#xD;
        -  Examine biomarker responses and establish a correlation with RP-3500 (camonsertib)&#xD;
           exposure and clinical outcomes.&#xD;
&#xD;
      The initial cohorts will test RP-3500 (camonsertib) as monotherapy. Additional cohorts will&#xD;
      enroll with RP-3500 (camonsertib) in combination with talazoparib or gemcitabine.&#xD;
&#xD;
      After the RP2D and schedule is determined, expansion cohort(s) for RP-3500 (camonsertib) will&#xD;
      be enrolled to study the anti-tumor effect, and further examine the safety and PK of RP-3500&#xD;
      (camonsertib) at the RP2D&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Anticipated">March 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2024</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>
    <intervention_model_description>Dose Escalation, expansion and phase 2</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To define the Maximum Tolerated Dose (MTD) which will then be used to inform and determine the Recommended Phase 2 Dose (RP2D) and schedule alone or in combination with talazoparib or gemcitabine</measure>
    <time_frame>Up to 90 days after last administration of study intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of Dose limiting Toxicities (DLTs)</measure>
    <time_frame>At the end of cycle 1 (each cycle is 21 days or 28 days)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability</measure>
    <time_frame>Up to 90 days after last administration of study intervention</time_frame>
    <description>Grade and frequency of adverse events and serious adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess preliminary anti-tumor activity with Overall Response Rate in patients with eligible advanced solid tumors by CT/MRI Response evaluation criteria in solid tumors (RECIST 1.1) or confirmed response in CA-125 or PSA per GCIG or PSWG criteria.</measure>
    <time_frame>About 1 year</time_frame>
    <description>Overall response rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess preliminary anti-tumor activity with Overall Response Rate in patients with eligible advanced solid tumors by CT/MRI Response evaluation criteria in solid tumors (RECIST 1.1)</measure>
    <time_frame>About 1 year</time_frame>
    <description>Objective response rate (ORR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess CR+PR+SD (≥ 4 months) based on RECIST v1.1, confirmed CA-125 response by GCIG criteria, or PSA response based on PCWG3</measure>
    <time_frame>About 1 year</time_frame>
    <description>Clinical Benefit Rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess preliminary anti-tumor activity with Duration of Response (DOR) in patients with eligible advanced solid tumors by CT/MRI Response evaluation criteria in solid tumors (RECIST 1.1).</measure>
    <time_frame>About 1 year</time_frame>
    <description>Duration of response (DOR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterize the pharmacokinetic profile of RP-3500 (camonsertib)</measure>
    <time_frame>Through Study Day 152</time_frame>
    <description>Area-under-the-curve (AUC 0-inf)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak plasma concentration</measure>
    <time_frame>Through Study Day 152</time_frame>
    <description>Cmax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess PK parameters of RP-3500 (camonsertib) monotherapy in fasted and fed states</measure>
    <time_frame>Through Study Day 152</time_frame>
    <description>Comparison of geometric mean ratios (GMR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic biomarkers of DNA damage (e.g. gH2AX) will be measured by immunohistochemistry and the percentage of positive cells will be compared between the pre and post treatment biopsies to evaluate target engagement</measure>
    <time_frame>Through Study Day -28 to Day 66 (each cycle is 21 days)</time_frame>
    <description>Tumor tissue samples will be collected pre and post dosing</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">451</enrollment>
  <condition>Advanced Solid Tumor</condition>
  <arm_group>
    <arm_group_label>RP-3500 (camonsertib) alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase 1:&#xD;
Multiple doses of RP-3500 (camonsertib) for oral administration alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion cohorts with RP-3500 (camonsertib)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase 2:&#xD;
Expansion cohorts with RP-3500 (camonsertib)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RP-3500 (camonsertib) with Talazoparib or Gemcitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase 1:&#xD;
Multiple doses of RP-3500 (camonsertib) for oral administration in combination with talazoparib or gemcitabine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RP-3500 (camonsertib)</intervention_name>
    <description>Oral ATR inhibitor</description>
    <arm_group_label>Expansion cohorts with RP-3500 (camonsertib)</arm_group_label>
    <arm_group_label>RP-3500 (camonsertib) alone</arm_group_label>
    <arm_group_label>RP-3500 (camonsertib) with Talazoparib or Gemcitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Talazoparib</intervention_name>
    <description>Oral PARP inhibitor</description>
    <arm_group_label>RP-3500 (camonsertib) with Talazoparib or Gemcitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine Injection</intervention_name>
    <description>Gemcitabine</description>
    <arm_group_label>RP-3500 (camonsertib) with Talazoparib or Gemcitabine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent, according to local guidelines, signed and dated by the&#xD;
             patient or legal guardian prior to the performance of any study-specific procedures,&#xD;
             sampling, or analyses.&#xD;
&#xD;
          -  Male or female and ≥ 18 years-of-age at the time of signature of the consent.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.&#xD;
&#xD;
          -  Histologically confirmed solid tumors resistant or refractory to standard treatment&#xD;
             and/or patients who are intolerant to standard therapy.&#xD;
&#xD;
          -  Measurable disease as per RECIST v1.1&#xD;
&#xD;
          -  Existing biomarker profile (tumor tissue or plasma) reported from a local test&#xD;
             obtained in a certified lab per institutional guidelines:&#xD;
&#xD;
          -  Available tumor tissue&#xD;
&#xD;
          -  Ability to comply with the protocol and study procedures detailed in the Schedule of&#xD;
             Assessments.&#xD;
&#xD;
          -  Ability to swallow and retain oral medications.&#xD;
&#xD;
          -  Acceptable organ function at screening&#xD;
&#xD;
          -  Acceptable blood counts at screening&#xD;
&#xD;
          -  Negative pregnancy test (serum or urine) for females of childbearing potential at&#xD;
             Screening and prior to first study drug.&#xD;
&#xD;
          -  Resolution of all toxicities of prior treatment or surgery.&#xD;
&#xD;
          -  Male patients with female partners of childbearing potential and females of&#xD;
             childbearing potential must follow a contraception method (oral contraceptives&#xD;
             allowed) during their participation in the study and for at least 6 months following&#xD;
             last dose of study drug. Male patients must also refrain from donating sperm during&#xD;
             their participation in the study and for 6 months following last dose of study drug.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chemotherapy, small molecule anticancer or biologic anticancer therapy given within 14&#xD;
             days prior to first dose of study drug.&#xD;
&#xD;
          -  History or current condition (such as transfusion dependent anemia or&#xD;
             thrombocytopenia), therapy, or laboratory abnormality that might confound the study&#xD;
             results, or interfere with the patient's participation for the full duration of the&#xD;
             study treatment.&#xD;
&#xD;
          -  Prior therapy with an ATR or DNA-dependent protein kinase (DNA-PK) inhibitor.&#xD;
&#xD;
          -  Known hypersensitivity to any of the ingredients of RP-3500 (camonsertib).&#xD;
&#xD;
          -  Life-threatening illness, medical condition, active uncontrolled infection, or organ&#xD;
             system dysfunction or other reasons which, in the investigator's opinion, could&#xD;
             compromise the patient's safety.&#xD;
&#xD;
          -  Uncontrolled, symptomatic brain metastases.&#xD;
&#xD;
          -  Uncontrolled high blood pressure&#xD;
&#xD;
          -  Patients with active, uncontrolled bacterial, fungal, or viral infection, including&#xD;
             hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus&#xD;
             (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.&#xD;
&#xD;
          -  Moderate or severe hepatic impairment (ie, Child-Pugh class B or C).&#xD;
&#xD;
          -  History or presence of an abnormal ECG that is clinically significant in the&#xD;
             investigator's opinion.&#xD;
&#xD;
          -  History of ventricular dysrhythmias or risk factors such as structural heart disease,&#xD;
             coronary heart disease (clinically significant electrolyte abnormalities or family&#xD;
             history of sudden unexplained death or long QT syndrome&#xD;
&#xD;
          -  Current treatment with medications that are well-known to prolong the QT interval&#xD;
&#xD;
          -  History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis&#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>Timothy A Yap, MBBS PhD FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gabriela Gomez, MD, MBA</last_name>
    <phone>857-340-5415</phone>
    <email>clininfo@reparerx.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Participating Site 1014</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Participating Site 1006</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Participating Site 1002</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Participating Site 1004</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Participating Site 1005</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Participating Site 1007</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Participating Site 1003</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Participating Site 1001</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Participating Site 2001</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Participating Site 4001</name>
      <address>
        <city>Copenhagen</city>
        <state>DK</state>
        <zip>2100 Ø</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Participating Site 3003</name>
      <address>
        <city>London</city>
        <zip>W1G 6AD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Participating Site 3001</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Participating Site 3002</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Denmark</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adult</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Talazoparib</mesh_term>
  </intervention_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/NCT04497116
org study id: RP-3500-01
secondary id: 2020-000301-87
nct id: NCT04497116
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
The primary purpose of this study is to define the maximum tolerated dose (MTD) and determine
      a recommended Phase 2 dose (RP2D) and schedule of orally-administered RP-3500 (camonsertib)
      alone or in combination with talazoparib, a PARP inhibitor, or Gemcitabine in patients with
      advanced solid tumors with ATR inhibitor-sensitizing mutations. This study will also evaluate
      the safety and tolerability of RP-3500 (camonsertib) alone or in combination with talazoparib
      or gemcitabine, examine both the pharmacokinetics (PK)and pharmacodynamics (PD)and
      investigate its anti-tumor activity in solid tumors.
This is a first-in-human, Phase 1/2a, multi-center, open-label, dose-escalation and expansion
      study to:

        -  Evaluate the safety profile and MTD of RP-3500 (camonsertib) when administered orally,
           alone and in combination with talazoparib or gemcitabine, to establish the dose and
           schedule recommended for the Phase 2

        -  Characterize the PK profile of RP-3500 (camonsertib) alone or in combination with
           talazoparib or gemcitabine

        -  Identify anti-tumor activity associated with RP-3500 (camonsertib) given alone or in
           combination with talazoparib or gemcitabine

        -  Examine biomarker responses and establish a correlation with RP-3500 (camonsertib)
           exposure and clinical outcomes.

      The initial cohorts will test RP-3500 (camonsertib) as monotherapy. Additional cohorts will
      enroll with RP-3500 (camonsertib) in combination with talazoparib or gemcitabine.

      After the RP2D and schedule is determined, expansion cohort(s) for RP-3500 (camonsertib) will
      be enrolled to study the anti-tumor effect, and further examine the safety and PK of RP-3500
      (camonsertib) at the RP2D
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Dose Escalation, expansion and phase 2
primary purpose: Treatment
masking: None (Open Label)
measure: To define the Maximum Tolerated Dose (MTD) which will then be used to inform and determine the Recommended Phase 2 Dose (RP2D) and schedule alone or in combination with talazoparib or gemcitabine
time frame: Up to 90 days after last administration of study intervention
measure: Frequency of Dose limiting Toxicities (DLTs)
time frame: At the end of cycle 1 (each cycle is 21 days or 28 days)
measure: Safety and tolerability
time frame: Up to 90 days after last administration of study intervention
description: Grade and frequency of adverse events and serious adverse events
measure: Assess preliminary anti-tumor activity with Overall Response Rate in patients with eligible advanced solid tumors by CT/MRI Response evaluation criteria in solid tumors (RECIST 1.1) or confirmed response in CA-125 or PSA per GCIG or PSWG criteria.
time frame: About 1 year
description: Overall response rate
measure: Assess preliminary anti-tumor activity with Overall Response Rate in patients with eligible advanced solid tumors by CT/MRI Response evaluation criteria in solid tumors (RECIST 1.1)
time frame: About 1 year
description: Objective response rate (ORR)
measure: Assess CR+PR+SD (≥ 4 months) based on RECIST v1.1, confirmed CA-125 response by GCIG criteria, or PSA response based on PCWG3
time frame: About 1 year
description: Clinical Benefit Rate
measure: Assess preliminary anti-tumor activity with Duration of Response (DOR) in patients with eligible advanced solid tumors by CT/MRI Response evaluation criteria in solid tumors (RECIST 1.1).
time frame: About 1 year
description: Duration of response (DOR)
measure: Characterize the pharmacokinetic profile of RP-3500 (camonsertib)
time frame: Through Study Day 152
description: Area-under-the-curve (AUC 0-inf)
measure: Peak plasma concentration
time frame: Through Study Day 152
description: Cmax
measure: To assess PK parameters of RP-3500 (camonsertib) monotherapy in fasted and fed states
time frame: Through Study Day 152
description: Comparison of geometric mean ratios (GMR)
measure: Pharmacodynamic biomarkers of DNA damage (e.g. gH2AX) will be measured by immunohistochemistry and the percentage of positive cells will be compared between the pre and post treatment biopsies to evaluate target engagement
time frame: Through Study Day -28 to Day 66 (each cycle is 21 days)
description: Tumor tissue samples will be collected pre and post dosing
arm group label: RP-3500 (camonsertib) alone
arm group type: Experimental
description: Phase 1:
Multiple doses of RP-3500 (camonsertib) for oral administration alone
arm group label: Expansion cohorts with RP-3500 (camonsertib)
arm group type: Experimental
description: Phase 2:
Expansion cohorts with RP-3500 (camonsertib)
arm group label: RP-3500 (camonsertib) with Talazoparib or Gemcitabine
arm group type: Experimental
description: Phase 1:
Multiple doses of RP-3500 (camonsertib) for oral administration in combination with talazoparib or gemcitabine
intervention type: Drug
intervention name: RP-3500 (camonsertib)
description: Oral ATR inhibitor
arm group label: Expansion cohorts with RP-3500 (camonsertib)
arm group label: RP-3500 (camonsertib) alone
arm group label: RP-3500 (camonsertib) with Talazoparib or Gemcitabine
intervention type: Drug
intervention name: Talazoparib
description: Oral PARP inhibitor
arm group label: RP-3500 (camonsertib) with Talazoparib or Gemcitabine
intervention type: Drug
intervention name: Gemcitabine Injection
description: Gemcitabine
arm group label: RP-3500 (camonsertib) with Talazoparib or Gemcitabine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Timothy A Yap, MBBS PhD FRCP
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
last name: Gabriela Gomez, MD, MBA
phone: 857-340-5415
email: clininfo@reparerx.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Canada
country: Denmark
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Gemcitabine
mesh term: Talazoparib
sharing ipd: No