<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/NCT04461600</url>
  </required_header>
  <id_info>
    <org_study_id>AL-TNBC-01</org_study_id>
    <nct_id>NCT04461600</nct_id>
  </id_info>
  <brief_title>A Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer</brief_title>
  <acronym>TENACITY</acronym>
  <official_title>A Phase 2, Multi-center, Open-label, Single Arm Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ayala Pharmaceuticals, Inc,</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ayala Pharmaceuticals, 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>
      The current study is designed to evaluate the efficacy and safety of AL101 monotherapy in&#xD;
      subjects with Notch-activated recurrent or metastatic TNBC; Notch activation will be&#xD;
      determined by a Next Generation Sequencing (NGS) test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 14, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
  <phase>Phase 2</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>Overall response rate (ORR)</measure>
    <time_frame>12 month</time_frame>
    <description>ORR is defined as partial response (PR) + complete response (CR) as assessed by investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical benefit response rate (CBR)</measure>
    <time_frame>12 month</time_frame>
    <description>Clinical benefit response rate (CBR) is defined as complete response (CR )+ partial response ( PR) + stable disease (SD) by investigator review based on RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR) by investigator review based on RECIST v1.1</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who have Progression free survival (PFS) at 6 months</measure>
    <time_frame>6 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QoL)-QLQ-C30</measure>
    <time_frame>12 month</time_frame>
    <description>The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / Quality of life scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / Quality of life represents a high Quality of life, but a high score for a symptom scale / item represents a high level of symptomatology / problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QoL)- QLQ-BR45</measure>
    <time_frame>12 month</time_frame>
    <description>Quality of life (QoL) as determined by European Organization for Research and Treatment of Cancer, by breast cancer quality of life questionnaire QLQ-BR45. QLQ-BR45 is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. The QLQ-BR45 incorporates nine multi-item scales to assess body image, sexual functioning, breast satisfaction, systemic therapy side,effects, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms, endocrine sexual symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss.&#xD;
All of the scales and single item measures range in score from 0 to 100. A high score for the functional scales and functional single items represents a high/healthy level of functioning, whereas a high score for the symptom scales and symptom item represents a high level of symptomatology or problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency, duration and severity of treatment-emergent adverse events and serious adverse events in subjects with recurrent or metastatic Triple Negative Breast Cancer receiving AL101 monotherapy.</measure>
    <time_frame>12 month</time_frame>
    <description>Frequency, duration and severity of treatment-emergent adverse events and serious adverse events.&#xD;
The incidence of clinically significant abnormalities in laboratory parameters, electrocardiograms, vital signs and physical examination will be used to describe treatment-emergent adverse events and serious adverse events.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">67</enrollment>
  <condition>Triple Negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>AL101</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AL101 is an inhibitor of gamma secretase-mediated Notch signaling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AL101</intervention_name>
    <description>AL101 is an inhibitor of gamma secretase-mediated Notch signaling.</description>
    <arm_group_label>AL101</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male of female subjects who are at least 18 years of age (inclusive) at the time of&#xD;
             signing the Informed Consent Form (ICF).&#xD;
&#xD;
          2. Have at least one measurable lesion per RECIST v1.1.&#xD;
&#xD;
          3. Have formalin-fixed paraffin-embedded (FFPE) tissue available from a metastatic&#xD;
             lesion; a tumor block or 25 unstained slides from an archived (within 2 years) or&#xD;
             fresh tumor samples (core or punch needle biopsy) are acceptable.&#xD;
&#xD;
          4. Documented tumor progression following no more than 3 lines of systemic chemotherapy,&#xD;
             PARP inhibitor therapy or immunotherapy for metastatic disease, as appropriate. Of&#xD;
             note, neoadjuvant and adjuvant therapy will not count as prior lines of therapy.&#xD;
&#xD;
          5. Histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC&#xD;
             defined as ER and progesterone receptor staining &lt;10%, and HER2 negative defined as&#xD;
             IHC 0 to 1+&#xD;
&#xD;
          6. Documented Notch activation from tumor biopsy results from within the last 2 years&#xD;
             from a commercially available NGS assay, LDT or other validated IUO clinical trial&#xD;
             assay.&#xD;
&#xD;
          7. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy&#xD;
             test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A known additional malignancy that is progressing or requires active treatment that is&#xD;
             considered medically active and may interfere in the ability to detect responses in&#xD;
             this subject. Exceptions include basal cell carcinoma of the skin, squamous cell&#xD;
             carcinoma of the skin that have undergone potentially curative therapy or in situ&#xD;
             cervical cancer.&#xD;
&#xD;
          2. BC that, in the opinion of the investigator, is considered amenable to potentially&#xD;
             curative treatment.&#xD;
&#xD;
          3. Symptomatic central nervous system (CNS) metastases.&#xD;
&#xD;
          4. Current or recent (within 2 months of IP administration) gastrointestinal (GI) disease&#xD;
             or disorders that increase the risk of diarrhea, such as inflammatory bowel disease&#xD;
             and Crohn's disease.&#xD;
&#xD;
          5. Developed immune-mediated colitis with immunotherapy unless resolved to G1 or lower&#xD;
             and without requirement of steroid treatment for at least 14 days prior to first dose&#xD;
             of IP.&#xD;
&#xD;
          6. Peripheral neuropathy Grade 2 for at least 14 days prior to first dose of IP.&#xD;
&#xD;
          7. Evidence of uncontrolled, active infection, requiring systemic anti-bacterial,&#xD;
             anti-viral or anti-fungal therapy ≤7 days prior to administration of IP such as known&#xD;
             active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).&#xD;
&#xD;
          8. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary&#xD;
             function or uncontrolled diabetes) or any important medical illness or abnormal&#xD;
             laboratory finding that would, in the investigator's judgment, increase the risk to&#xD;
             the subject associated with his or her participation in the study.&#xD;
&#xD;
          9. Eastern Cooperative Oncology Group (ECOG) performance status ≥2.&#xD;
&#xD;
         10. Abnormal organ and marrow function defined as:&#xD;
&#xD;
               1. neutrophils &lt;1000/mm3,&#xD;
&#xD;
               2. platelet count &lt;75,000/mm3,&#xD;
&#xD;
               3. hemoglobin &lt;8 g/dL,&#xD;
&#xD;
               4. total bilirubin &gt;1.5 upper limit of normal (ULN) (except known Gilbert's syndrome&#xD;
                  whereby the total bilirubin must be &lt; 5 mg/dL),&#xD;
&#xD;
               5. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) &gt;2.5 ULN OR&#xD;
                  &gt;5 ULN for subjects with liver metastases,&#xD;
&#xD;
               6. creatinine clearance (CrCl) &lt;50 mL/min (calculation of CrCl will be based on&#xD;
                  acceptable institution standard),&#xD;
&#xD;
               7. uncontrolled triglyceride ≥Grade 2 elevations per CTCAE v5.0 (&gt;300 mg/dL or &gt;3.42&#xD;
                  mmol/L).&#xD;
&#xD;
         11. Myocardial infarction within 6 months prior to enrollment or has New York Heart&#xD;
             Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe&#xD;
             uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute&#xD;
             ischemia or active conduction system abnormalities.&#xD;
&#xD;
         12. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥480 msec.&#xD;
&#xD;
         13. Completed palliative radiation therapy &lt; 7 days prior to initiating IP.&#xD;
&#xD;
         14. Prior treatment with gamma secretase inhibitors.&#xD;
&#xD;
         15. Last chemotherapy, biologic, or investigational therapy agent at least 4 weeks or 5&#xD;
             half-lives (whichever is shorter) prior to initiating IP; at least 6 weeks if the last&#xD;
             regimen included BCNU or mitomycin C. Prior treatment with investigational monoclonal&#xD;
             antibody will be reviewed case-by-case by the Sponsor.&#xD;
&#xD;
         16. Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg/day of&#xD;
             prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days&#xD;
             prior to the first dose of IP. The use of physiologic doses of corticosteroids may be&#xD;
             approved after consultation with the Sponsor.&#xD;
&#xD;
         17. Use of strong inhibitors of CYP3A4 within 1 week or 5 half-lives (whichever is longer)&#xD;
             or strong inducers of CYP3A4 within 2 weeks or 5 half-lives (whichever is longer).&#xD;
&#xD;
         18. Life expectancy is less than 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Banner MD Anderson Cancer Center</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California at San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Hematology Oncology</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33709</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Clinic</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville- James Brown Cancer Center</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maryland Oncology Hematology</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>20144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Cancer Care</name>
      <address>
        <city>Bolivar</city>
        <state>Missouri</state>
        <zip>63613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center (MSKCC)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston Oncology</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Hospital</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103102</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petah Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaplan Medical Center</name>
      <address>
        <city>Reẖovot</city>
        <zip>7661041</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vall d'Hebron University Hospital</name>
      <address>
        <city>Barcelona</city>
        <zip>8035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Català d'Oncologia</name>
      <address>
        <city>Barcelona</city>
        <zip>8908</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Virgen de la Victoria</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie Hospital</name>
      <address>
        <city>Manchester</city>
        <state>England</state>
        <zip>M204BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Edinburgh</name>
      <address>
        <city>Edinburgh</city>
        <state>Scotland</state>
        <zip>EH42XR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Israel</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>March 31, 2022</last_update_submitted>
  <last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TNBC, Notch activated</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>
  <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/NCT04461600
org study id: AL-TNBC-01
nct id: NCT04461600
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The current study is designed to evaluate the efficacy and safety of AL101 monotherapy in
      subjects with Notch-activated recurrent or metastatic TNBC; Notch activation will be
      determined by a Next Generation Sequencing (NGS) test.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate (ORR)
time frame: 12 month
description: ORR is defined as partial response (PR) + complete response (CR) as assessed by investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
measure: Clinical benefit response rate (CBR)
time frame: 12 month
description: Clinical benefit response rate (CBR) is defined as complete response (CR )+ partial response ( PR) + stable disease (SD) by investigator review based on RECIST v1.1
measure: Duration of response (DOR) by investigator review based on RECIST v1.1
time frame: 12 month
measure: Progression free survival (PFS)
time frame: 12 month
measure: Proportion of subjects who have Progression free survival (PFS) at 6 months
time frame: 6 month
measure: Overall survival (OS)
time frame: 12 month
measure: Quality of life (QoL)-QLQ-C30
time frame: 12 month
description: The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / Quality of life scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / Quality of life represents a high Quality of life, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
measure: Quality of life (QoL)- QLQ-BR45
time frame: 12 month
description: Quality of life (QoL) as determined by European Organization for Research and Treatment of Cancer, by breast cancer quality of life questionnaire QLQ-BR45. QLQ-BR45 is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. The QLQ-BR45 incorporates nine multi-item scales to assess body image, sexual functioning, breast satisfaction, systemic therapy side,effects, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms, endocrine sexual symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss.
All of the scales and single item measures range in score from 0 to 100. A high score for the functional scales and functional single items represents a high/healthy level of functioning, whereas a high score for the symptom scales and symptom item represents a high level of symptomatology or problems.
measure: Frequency, duration and severity of treatment-emergent adverse events and serious adverse events in subjects with recurrent or metastatic Triple Negative Breast Cancer receiving AL101 monotherapy.
time frame: 12 month
description: Frequency, duration and severity of treatment-emergent adverse events and serious adverse events.
The incidence of clinically significant abnormalities in laboratory parameters, electrocardiograms, vital signs and physical examination will be used to describe treatment-emergent adverse events and serious adverse events.
arm group label: AL101
arm group type: Experimental
description: AL101 is an inhibitor of gamma secretase-mediated Notch signaling.
intervention type: Drug
intervention name: AL101
description: AL101 is an inhibitor of gamma secretase-mediated Notch signaling.
arm group label: AL101
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: Belgium
country: Israel
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
sharing ipd: No