<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/NCT03838367</url>
  </required_header>
  <id_info>
    <org_study_id>CD07_TNBC</org_study_id>
    <nct_id>NCT03838367</nct_id>
  </id_info>
  <brief_title>Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ mTNBC</brief_title>
  <official_title>A Phase Ib/II Study of Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CytoDyn, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amarex Clinical Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CytoDyn, Inc.</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>
      This is a phase Ib/II Study of Leronlimab (PRO 140) combined with Carboplatin in Patients&#xD;
      with CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC).&#xD;
&#xD;
      Study population will consist of patients with CCR5-positive, locally advanced or metastatic&#xD;
      triple-negative breast cancer (mTNBC) who are naïve to chemotherapy in metastatic setting but&#xD;
      have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings&#xD;
      (first-line).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase Ib&#xD;
&#xD;
      Phase Ib is a dose escalation phase with 3 dose levels (cohorts) of leronlimab (PRO 140)&#xD;
      administered in combination with a fixed dose of carboplatin at AUC 5. This dose finding&#xD;
      portion of study will follow a &quot;3+3&quot; designed to determine the maximum tolerated dose (MTD)&#xD;
      of leronlimab (PRO 140) administered as subcutaneous injection in subjects with&#xD;
      histologically confirmed mTNBC that express CCR5.&#xD;
&#xD;
      Phase II&#xD;
&#xD;
      Phase II is a single arm study with 30 patients in order to test the hypothesis that the&#xD;
      combination of carboplatin AUC 5 intravenously and MTD of leronlimab (PRO 140) SC will&#xD;
      increase PFS in patients with CCR5 + mTNBC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 22, 2019</start_date>
  <completion_date type="Anticipated">September 16, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 15, 2022</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase Ib: Maximum Tolerated Dose (MTD) of leronlimab (PRO 140) when combined with carboplatin AUC5</measure>
    <time_frame>Cycle 1 (21 days)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase II: Progression free survival (PFS) defined as time in months from the date of first study treatment to the date of disease progression or death from any cause, whichever comes first.</measure>
    <time_frame>Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase I: The number, frequency, and severity of adverse events (AEs) collected from the time of first treatment until 12 weeks after study treatment completion to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC.</measure>
    <time_frame>From Cycle 1, Day 1 (each treatment cycle is 21 days) to 12 weeks after the last dose of study drug)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Progression Free Survival (PFS) according to RECIST v1.1 in participants with Detectable Programmed Death-Ligand 1 (PD-L1)</measure>
    <time_frame>Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Overall response rate (ORR, defined as Complete Response (CR) + Partial Response (PR)), and clinical benefit rate (CBR, defined as CR + PR + Stable Disease (SD)) in subjects with CCR5+ mTNBC treated with leronlimab (PRO 140) and carboplatin.</measure>
    <time_frame>Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Time to new metastases (TTNM)</measure>
    <time_frame>Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: The change from baseline in circulating tumor cells (CTC) level in the peripheral blood.</measure>
    <time_frame>Every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Overall survival defined as time in months from the date of first study treatment to the date of death;</measure>
    <time_frame>From Day 1 to death from any cause, assessed up to 2 years after completion of treatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: The number, frequency, and severity of AEs collected from the time of first treatment until 12 weeks after study treatment completion to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC.</measure>
    <time_frame>From Cycle 1, Day 1 (each treatment cycle is 21 days) to 12 weeks after the last dose of study drug)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Measure immune biomarkers (PD-L1) in CTCs, metastatic tissue and immune cells such as CAMLs and correlate with therapeutic benefit (PFS)</measure>
    <time_frame>Every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Correlation between CCR5 expression (CTCs, CAMLs) and PD- L1 expression.</measure>
    <time_frame>Every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months.</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Triple Negative Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>Phase I-Cohort A: 350 mg PRO 140 SC weekly + AUC 5 Carboplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort A: 350 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase I-Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase I-Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase II- MTD to be established for the combination treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MTD PRO 140 SC + AUC 5 Carboplatin in 30 subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>350 mg leronlimab</intervention_name>
    <description>leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.</description>
    <arm_group_label>Phase I-Cohort A: 350 mg PRO 140 SC weekly + AUC 5 Carboplatin</arm_group_label>
    <other_name>PRO 140</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>525 mg leronlimab</intervention_name>
    <description>leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.</description>
    <arm_group_label>Phase I-Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin</arm_group_label>
    <other_name>PRO 140</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>700 mg leronlimab</intervention_name>
    <description>leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.</description>
    <arm_group_label>Phase I-Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin</arm_group_label>
    <other_name>PRO 140</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AUC 5 Carboplatin</intervention_name>
    <description>Carboplatin is an anticancer drug chemotherapy drug.</description>
    <arm_group_label>Phase I-Cohort A: 350 mg PRO 140 SC weekly + AUC 5 Carboplatin</arm_group_label>
    <arm_group_label>Phase I-Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin</arm_group_label>
    <arm_group_label>Phase I-Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin</arm_group_label>
    <arm_group_label>Phase II- MTD to be established for the combination treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Maximum Tolerated Dose (MTD) of leronlimab</intervention_name>
    <description>The decision on the MTD will be made following the results obtained from Phase I studies</description>
    <arm_group_label>Phase II- MTD to be established for the combination treatment</arm_group_label>
    <other_name>PRO 140</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must have a histologically confirmed diagnosis of TNBC. Must demonstrate HER-2&#xD;
             negative (IHC 0, 1+, or fluorescence in situ hybridization (FISH) negative and ER&lt;1%,&#xD;
             and PR &lt; 1%, per ASCO/CAP criteria);&#xD;
&#xD;
          2. Demonstrate CCR5 + by IHC (&gt;10% membranous staining completed at the reference&#xD;
             laboratory of Dr. Hallgeir Rui at Medical College of Wisconsin).&#xD;
&#xD;
             Note: This test will be done as part of the pre-screening period. It will be performed&#xD;
             in archival metastatic tissue. If archival tissue is not available then, fresh biopsy&#xD;
             will be done;&#xD;
&#xD;
          3. Be willing to provide tissue from a newly obtained core or excisional biopsy of a&#xD;
             tumor lesion (in case archival tissue is not available);&#xD;
&#xD;
          4. Subjects must be untreated or naïve to chemotherapy and/or checkpoint inhibitors&#xD;
             exposure in metastatic setting and have been exposed to anthracyclines and taxane in&#xD;
             neoadjuvant and adjuvant settings (first-line); Note: Patients who have been exposed&#xD;
             to carboplatin in neoadjuvant or adjuvant setting will be allowed to enroll, if they&#xD;
             have progressed ≥ 6 months from completion of treatment.&#xD;
&#xD;
          5. Patients must have measurable disease based on RECIST v1.1;&#xD;
&#xD;
          6. Female patients, ≥ 18 years of age;&#xD;
&#xD;
          7. Patients must exhibit a/an ECOG performance status of 0-1;&#xD;
&#xD;
          8. Life expectancy of at least 6 months;&#xD;
&#xD;
          9. Patients must have adequate organ and bone marrow function within 28 days prior to&#xD;
             registration, as defined below:&#xD;
&#xD;
               -  leukocytes ≥ 3,000/mcL;&#xD;
&#xD;
               -  absolute neutrophil count ≥ 1,500/mcL;&#xD;
&#xD;
               -  platelets ≥ 100,000/mcL;&#xD;
&#xD;
               -  total bilirubin: within normal institutional limits;&#xD;
&#xD;
               -  AST(SGOT) &amp;ALT(SPGT) ≤ 2.5 X institutional upper limit of normal (ULN)&#xD;
                  (applicable to all patients, irrespective of liver disease or metastasis); and&#xD;
&#xD;
               -  creatinine: within normal institutional limits.&#xD;
&#xD;
         10. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered&#xD;
             not clinically significant by the Principal Investigator.&#xD;
&#xD;
         11. Females of child-bearing potential (FOCBP) and males must agree to use two medically&#xD;
             accepted methods of contraception with hormonal or barrier method of birth control, or&#xD;
             abstinence, prior to study entry, for the duration of study participation and for 60&#xD;
             days after the last dose of study drug (Refer to Appendix 1). Should a female patient&#xD;
             become pregnant or suspect she is pregnant while participating in this study, she&#xD;
             should inform her treating physician immediately. NOTE: A FOCBP is any woman&#xD;
             (regardless of sexual orientation, having undergone a tubal ligation, or remaining&#xD;
             celibate by choice) who meets the following criteria:&#xD;
&#xD;
               -  Has not undergone a hysterectomy or bilateral oophorectomy; and&#xD;
&#xD;
               -  Has had menses at any time in the preceding 12 consecutive months (and therefore&#xD;
                  has not been naturally postmenopausal for &gt; 12 months).&#xD;
&#xD;
         12. FOCBP must have a negative serum pregnancy test at Screening Visit and negative urine&#xD;
             pregnancy test prior to receiving the first dose of study drug; and&#xD;
&#xD;
         13. Patients must have the ability to understand and the willingness to sign a written&#xD;
             informed consent prior to registration on study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. HER-2 overexpressed/amplified MBC (Appendix 2 for guidelines from ASCO);&#xD;
&#xD;
          2. ER and or PR expressing tumors;&#xD;
&#xD;
          3. Subjects who have had previous systemic chemotherapy for metastatic breast cancer;&#xD;
&#xD;
          4. Is currently participating and receiving study therapy or has participated in a study&#xD;
             of an investigational agent and received study therapy or used an investigational&#xD;
             device within 28 days prior to enrollment;&#xD;
&#xD;
          5. Patients who have a history of allergic reactions attributed to compounds of similar&#xD;
             chemical or biologic composition to leronlimab (PRO 140) are not eligible;&#xD;
&#xD;
          6. Patients who have had prior exposure to CCR5 antagonists are not eligible;&#xD;
&#xD;
          7. Patients who have a known additional malignancy that is progressing or requires active&#xD;
             treatment are not eligible. Patients who have had a prior diagnosis of cancer and if&#xD;
             it has been &lt;3 years since their last treatment are not eligible. Exceptions include&#xD;
             basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has&#xD;
             undergone potentially curative therapy or in situ cervical cancer;&#xD;
&#xD;
          8. Has an active infection requiring systemic therapy. Note: Patients must complete any&#xD;
             treatment with antibiotics prior to registration;&#xD;
&#xD;
          9. Patients who have a known HIV positive status or known/ active Hepatitis B and/or C&#xD;
             infection are not eligible;&#xD;
&#xD;
         10. Has known active central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis. Note: Subjects with previously treated brain metastases may participate&#xD;
             provided they are stable (without evidence of progression by imaging for at least four&#xD;
             weeks prior to the first dose of trial treatment and any neurologic symptoms have&#xD;
             returned to baseline), have no evidence of new or enlarging brain metastases, and are&#xD;
             not using steroids for at least 7 days prior to trial treatment. This exception does&#xD;
             not include carcinomatous meningitis which is excluded regardless of clinical&#xD;
             stability;&#xD;
&#xD;
         11. Has a history or current evidence of any condition, therapy, or laboratory abnormality&#xD;
             that might confound the results of the trial, interfere with the subject's&#xD;
             participation for the full duration of the trial, or is not in the best interest of&#xD;
             the subject to participate, in the opinion of the treating investigator;&#xD;
&#xD;
         12. Has known psychiatric or substance abuse disorders that would interfere with&#xD;
             cooperation with the requirements of the trial; and&#xD;
&#xD;
         13. Is pregnant or breastfeeding, or expecting to conceive or have children within the&#xD;
             projected duration of the trial, starting with the pre-screening or screening visit&#xD;
             through the duration of study participation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Quest Clinical Research</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CD07 Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>March 18, 2022</last_update_submitted>
  <last_update_submitted_qc>March 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TNBC</keyword>
  <keyword>PRO 140</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leronlimab</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>HIV Antibodies</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03838367
org study id: CD07_TNBC
nct id: NCT03838367
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a phase Ib/II Study of Leronlimab (PRO 140) combined with Carboplatin in Patients
      with CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC).

      Study population will consist of patients with CCR5-positive, locally advanced or metastatic
      triple-negative breast cancer (mTNBC) who are naïve to chemotherapy in metastatic setting but
      have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings
      (first-line).
Phase Ib

      Phase Ib is a dose escalation phase with 3 dose levels (cohorts) of leronlimab (PRO 140)
      administered in combination with a fixed dose of carboplatin at AUC 5. This dose finding
      portion of study will follow a "3+3" designed to determine the maximum tolerated dose (MTD)
      of leronlimab (PRO 140) administered as subcutaneous injection in subjects with
      histologically confirmed mTNBC that express CCR5.

      Phase II

      Phase II is a single arm study with 30 patients in order to test the hypothesis that the
      combination of carboplatin AUC 5 intravenously and MTD of leronlimab (PRO 140) SC will
      increase PFS in patients with CCR5 + mTNBC.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase Ib: Maximum Tolerated Dose (MTD) of leronlimab (PRO 140) when combined with carboplatin AUC5
time frame: Cycle 1 (21 days)
measure: Phase II: Progression free survival (PFS) defined as time in months from the date of first study treatment to the date of disease progression or death from any cause, whichever comes first.
time frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment
measure: Phase I: The number, frequency, and severity of adverse events (AEs) collected from the time of first treatment until 12 weeks after study treatment completion to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC.
time frame: From Cycle 1, Day 1 (each treatment cycle is 21 days) to 12 weeks after the last dose of study drug)
measure: Phase II: Progression Free Survival (PFS) according to RECIST v1.1 in participants with Detectable Programmed Death-Ligand 1 (PD-L1)
time frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment
measure: Phase II: Overall response rate (ORR, defined as Complete Response (CR) + Partial Response (PR)), and clinical benefit rate (CBR, defined as CR + PR + Stable Disease (SD)) in subjects with CCR5+ mTNBC treated with leronlimab (PRO 140) and carboplatin.
time frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment
measure: Phase II: Time to new metastases (TTNM)
time frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment
measure: Phase II: The change from baseline in circulating tumor cells (CTC) level in the peripheral blood.
time frame: Every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months.
measure: Phase II: Overall survival defined as time in months from the date of first study treatment to the date of death;
time frame: From Day 1 to death from any cause, assessed up to 2 years after completion of treatment.
measure: Phase II: The number, frequency, and severity of AEs collected from the time of first treatment until 12 weeks after study treatment completion to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC.
time frame: From Cycle 1, Day 1 (each treatment cycle is 21 days) to 12 weeks after the last dose of study drug)
measure: Measure immune biomarkers (PD-L1) in CTCs, metastatic tissue and immune cells such as CAMLs and correlate with therapeutic benefit (PFS)
time frame: Every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months.
measure: Correlation between CCR5 expression (CTCs, CAMLs) and PD- L1 expression.
time frame: Every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months.
arm group label: Phase I-Cohort A: 350 mg PRO 140 SC weekly + AUC 5 Carboplatin
arm group type: Experimental
description: Cohort A: 350 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
arm group label: Phase I-Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin
arm group type: Experimental
description: Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
arm group label: Phase I-Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin
arm group type: Experimental
description: Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
arm group label: Phase II- MTD to be established for the combination treatment
arm group type: Experimental
description: MTD PRO 140 SC + AUC 5 Carboplatin in 30 subjects
intervention type: Drug
intervention name: 350 mg leronlimab
description: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
arm group label: Phase I-Cohort A: 350 mg PRO 140 SC weekly + AUC 5 Carboplatin
other name: PRO 140
intervention type: Drug
intervention name: 525 mg leronlimab
description: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
arm group label: Phase I-Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin
other name: PRO 140
intervention type: Drug
intervention name: 700 mg leronlimab
description: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
arm group label: Phase I-Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin
other name: PRO 140
intervention type: Drug
intervention name: AUC 5 Carboplatin
description: Carboplatin is an anticancer drug chemotherapy drug.
arm group label: Phase I-Cohort A: 350 mg PRO 140 SC weekly + AUC 5 Carboplatin
arm group label: Phase I-Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin
arm group label: Phase I-Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin
arm group label: Phase II- MTD to be established for the combination treatment
intervention type: Drug
intervention name: Maximum Tolerated Dose (MTD) of leronlimab
description: The decision on the MTD will be made following the results obtained from Phase I studies
arm group label: Phase II- MTD to be established for the combination treatment
other name: PRO 140
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
mesh term: Leronlimab
mesh term: Carboplatin
mesh term: HIV Antibodies