<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/NCT01703572</url>
  </required_header>
  <id_info>
    <org_study_id>52M51-001</org_study_id>
    <nct_id>NCT01703572</nct_id>
  </id_info>
  <brief_title>A Dose Escalation Study of OMP-52M51 in Subjects With Lymphoid Malignancies</brief_title>
  <official_title>A Phase 1 Dose Escalation Study of OMP-52M51 in Subjects With Lymphoid Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OncoMed Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mereo BioPharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label Phase 1a dose escalation study of single-agent OMP-52M51 in subjects&#xD;
      with relapsed or refractory lymphoid malignancies. Study includes a dose escalation phase and&#xD;
      expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics,&#xD;
      biomarkers, and efficacy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety profile of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies</measure>
    <time_frame>Subjects will be assessed for DLTs from Days 0-29. Adverse events will be reported through 30 days after the last dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies</measure>
    <time_frame>PK analyses at various time points following the 1st and 2nd doses, immediately pre and post-dose for all subsequent doses at treatment term, every 4 weeks after discontinuation of study drug or 12 weeks</time_frame>
    <description>Apparent half life, AUC, clearance, volume of distribution</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies</measure>
    <time_frame>At baseline, every 4 weeks, at treatment termination and every 4 weeks after the discontinuation of the study drug for 12 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preliminary efficacy of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies</measure>
    <time_frame>Evaluation for response will be assessed every 56 days and will be based on disease specific criteria.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Relapsed or Refractory Lymphoid Malignancies</condition>
  <arm_group>
    <arm_group_label>OMP-52M51</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OMP-52M51</intervention_name>
    <arm_group_label>OMP-52M51</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Lymphoid malignancy that has relapsed or is refractory after two or more treatments&#xD;
             that are FDA approved or are commonly used clinically.&#xD;
&#xD;
          2. Subjects must have progressive disease requiring therapy. Subjects who are candidates&#xD;
             for observation only are not eligible.&#xD;
&#xD;
          3. Subjects are either not currently considered to be candidates or refuse potentially&#xD;
             curative therapies including peripheral stem cell or bone marrow transplant&#xD;
&#xD;
          4. Subjects must have measurable disease as per disease specific criteria&#xD;
&#xD;
          5. Must have received their last chemotherapy, biologic, radiotherapy, or investigational&#xD;
             therapy at least 4 weeks prior to enrollment; 12 weeks from their last&#xD;
             radioimmunotherapy; 3 months if the last therapy was bone marrow/ peripheral stem cell&#xD;
             transplant.&#xD;
&#xD;
          6. Age &gt;18 years&#xD;
&#xD;
          7. ECOG performance status &lt;2&#xD;
&#xD;
          8. Normal Ejection Fraction on ECHO scan&#xD;
&#xD;
          9. Subjects must have normal organ and marrow function as defined below:&#xD;
&#xD;
             Absolute neutrophil count &gt;1000/mL Platelets &gt;75,000/mL For subjects with known marrow&#xD;
             infiltration, ANC ≥500 and platelets ≥30,000 Total bilirubin &lt;1.5 X institutional&#xD;
             upper limit of normal (ULN) (&lt;2X ULN for subjects with Gilbert's syndrome) AST (SGOT)&#xD;
             and ALT (SGPT) &lt;3 X institutional ULN (for subjects with hepatic involvement &lt;5 X&#xD;
             institutional ULN) PT/INR and aPTT within 1.5 X institutional ULN Creatinine &lt;1.5 X&#xD;
             institutional ULN OR Creatinine clearance &gt;60 mL/min/1.73 m2 for subjects with&#xD;
             creatinine levels above institutional normal&#xD;
&#xD;
         10. Women of childbearing potential must have had a prior hysterectomy or have a negative&#xD;
             serum pregnancy test and be using adequate contraception prior to study entry and must&#xD;
             agree to use adequate contraception from study entry through at least 6 months after&#xD;
             discontinuation of study drug. Men must also agree to use adequate contraception&#xD;
             (hormonal or barrier method of birth control; abstinence) prior to study entry and&#xD;
             from study entry through at least 6 months after discontinuation of study drug. Should&#xD;
             a woman enrolled in the study or a female partner of a man enrolled in the study&#xD;
             become pregnant or suspect she is pregnant while participating in this study or within&#xD;
             6 months after discontinuation of study, she should inform the Investigator&#xD;
             immediately.&#xD;
&#xD;
         11. Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects who meet any of the following criteria will not be eligible for participation in&#xD;
        the study:&#xD;
&#xD;
          1. Currently receiving any therapeutic treatment for lymphoid malignancies including&#xD;
             other investigational agents&#xD;
&#xD;
          2. Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors&#xD;
&#xD;
          3. Active CNS involvement, uncontrolled seizure disorder, or active neurologic disease&#xD;
&#xD;
          4. History of a Grade 4 allergic reaction attributed to humanized or human monoclonal&#xD;
             antibody therapy&#xD;
&#xD;
          5. Significant intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          6. Pregnant women or nursing women&#xD;
&#xD;
          7. Ongoing malignancies or malignancies in remission &lt;3 years other than the lymphoid&#xD;
             malignancies included in this trial. Patients with history of known skin cancers&#xD;
             including non-melanotic skin cancers within the past 3 years will not be included in&#xD;
             this trial. The following prior malignancies are allowable irrespective of when they&#xD;
             occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, and low-grade&#xD;
             local bladder cancer.&#xD;
&#xD;
          8. Subjects with known HIV infection&#xD;
&#xD;
          9. Known bleeding disorder or coagulopathy&#xD;
&#xD;
         10. Subjects receiving heparin, warfarin, or other similar anticoagulants, except for&#xD;
             subjects on low molecular weight heparin for DVT/PE prophylaxis. Note: Subjects may be&#xD;
             receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.&#xD;
&#xD;
         11. New York Heart Association Classification II, III, or IV&#xD;
&#xD;
         12. Subjects with a blood pressure of &gt;140/90 mmHg that is not responsive to medical&#xD;
             therapy. Subjects taking antihypertensive medications must be taking ≤2 medications to&#xD;
             obtain this level of blood pressure control.&#xD;
&#xD;
         13. Subjects with EKG evidence of ischemia or ≥Grade 2 ventricular arrhythmia, subjects&#xD;
             who have a history of acute myocardial infarction within 6 months, or subjects with&#xD;
             unstable angina.&#xD;
&#xD;
         14. Subjects with known clinically significant gastrointestinal disease including, but not&#xD;
             limited to, inflammatory bowel disease&#xD;
&#xD;
         15. Subjects with diarrhea at time of enrollment or have an ongoing requirement for anti&#xD;
             diarrheal therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UC San Diego Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital, Anschutz Cancer Pavilion</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Health Davis Cancer Pavilion and Shands Med Plaza</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198-7680</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cornell University Division of Hematology and Medical Oncology</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Clinical Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>97219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Cancer Institute</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sara Cannon Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>September 7, 2020</last_update_submitted>
  <last_update_submitted_qc>September 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase 1</keyword>
  <keyword>Dose escalation</keyword>
  <keyword>relapsed or refractory</keyword>
  <keyword>lymphoid malignancies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_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/NCT01703572
org study id: 52M51-001
nct id: NCT01703572
lead sponsor: 
has dmc: No
This is an open-label Phase 1a dose escalation study of single-agent OMP-52M51 in subjects
      with relapsed or refractory lymphoid malignancies. Study includes a dose escalation phase and
      expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics,
      biomarkers, and efficacy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety profile of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
time frame: Subjects will be assessed for DLTs from Days 0-29. Adverse events will be reported through 30 days after the last dose
measure: Pharmacokinetics (PK) of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
time frame: PK analyses at various time points following the 1st and 2nd doses, immediately pre and post-dose for all subsequent doses at treatment term, every 4 weeks after discontinuation of study drug or 12 weeks
description: Apparent half life, AUC, clearance, volume of distribution
measure: Immunogenicity of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
time frame: At baseline, every 4 weeks, at treatment termination and every 4 weeks after the discontinuation of the study drug for 12 weeks.
measure: Preliminary efficacy of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
time frame: Evaluation for response will be assessed every 56 days and will be based on disease specific criteria.
arm group label: OMP-52M51
arm group type: Experimental
intervention type: Drug
intervention name: OMP-52M51
arm group label: OMP-52M51
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms