<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/NCT02194426</url>
  </required_header>
  <id_info>
    <org_study_id>MP0250-CP101</org_study_id>
    <secondary_id>2014-000366-21</secondary_id>
    <nct_id>NCT02194426</nct_id>
  </id_info>
  <brief_title>First-in-human Study to Investigate the Safety, Tolerability and Blood Levels of the Test Drug MP0250 in Cancer Patients</brief_title>
  <official_title>A Phase I Multi-centre, Open-label, Repeated-dose, Dose-escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MP0250 in Patients With Advanced Solid Tumours</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Molecular Partners AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Molecular Partners AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is looking at a new DARPin® drug candidate, called MP0250. There is&#xD;
      evidence from preclinical studies that MP0250 may be effective in the treatment of cancer.&#xD;
      This is the first study of MP0250 in humans and its main purpose is to test its safety and&#xD;
      tolerability in patients with cancer. This study will also examine how the drug is changed by&#xD;
      and removed from the body and look for indicators that the drug may be effective against&#xD;
      cancer. This study will test several different dose levels of the study drug to determine the&#xD;
      safety and tolerability profile of the drug.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">February 20, 2018</completion_date>
  <primary_completion_date type="Actual">February 20, 2018</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>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>Proportion of patients with dose limiting toxicities</measure>
    <time_frame>From the Day 0 (first infusion) up to 35 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Vital signs</measure>
    <time_frame>From inclusion (week -4) up to week 56</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of adverse events</measure>
    <time_frame>From inclusion up to week 56</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>MP0250 plasma concentration-time profile</measure>
    <time_frame>From Day 0 (first infusion) up to week 56</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Nature of dose limiting toxicities</measure>
    <time_frame>From the Day 0 (first infusion) up to 35 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Nature of adverse events</measure>
    <time_frame>From inclusion up to week 56</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of adverse events</measure>
    <time_frame>From inclusion up to week 56</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood chemistry values</measure>
    <time_frame>From inclusion (week -4) up to week 56</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Haematology values</measure>
    <time_frame>From inclusion (week -4) up to week 56</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine values</measure>
    <time_frame>From inclusion (week -4) up to week 56</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Electrocardiogram measurements</measure>
    <time_frame>From inclusion (week -4) up to week 56</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics parameters</measure>
    <time_frame>From Day 0 (first infusion) up to week 56</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of anti-drug-antibodies</measure>
    <time_frame>From the Day 0 (first infusion) up to week 56</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Titre of anti-drug-antibodies</measure>
    <time_frame>From the Day 0 (first infusion) up to week 56</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>MP0250</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>see section &quot;intervention description&quot; below</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MP0250</intervention_name>
    <description>Intravenous application by infusion of MP0250 at up to six dose levels, every other week for up to 24 infusions.</description>
    <arm_group_label>MP0250</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female ≥ 18 years&#xD;
&#xD;
          2. Histologically confirmed and documented advanced or metastatic solid tumour refractory&#xD;
             to at least 1 prior regimen of standard treatment or for which no curative therapy is&#xD;
             available and for whom MP0250 is a reasonable option&#xD;
&#xD;
          3. Progressive or stable disease documented radiologically in the 4 weeks prior to&#xD;
             screening&#xD;
&#xD;
          4. Presence of a measurable tumour or a tumour evaluable per RECIST v1.1&#xD;
&#xD;
          5. ECOG performance status ≤ 1&#xD;
&#xD;
          6. Life expectancy ≥ 12 weeks&#xD;
&#xD;
          7. Adequate haematological function prior to first dose, defined as:&#xD;
&#xD;
               -  Absolute neutrophils count ≥ 1500 cells/μL&#xD;
&#xD;
               -  Haemoglobin ≥ 9 g/dL&#xD;
&#xD;
               -  Platelet count &gt; 100,000/μL&#xD;
&#xD;
               -  Prothrombin time or partial thromboplastin time &lt; 1.2 x ULN&#xD;
&#xD;
          8. Adequate renal function prior to first dose, defined as either&#xD;
&#xD;
               -  Serum creatinine &lt; 1.5 mg/dL or&#xD;
&#xD;
               -  Serum creatinine clearance ≥ 50 mL/min/m2 (by Cockroft-Gault equation)&#xD;
&#xD;
          9. Adequate hepatic function prior to first dose, defined as&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 x ULN&#xD;
&#xD;
               -  AST/ALT ≤ 2.5 x ULN, or ≤ 5 x ULN if known hepatic metastases&#xD;
&#xD;
               -  Alkaline phosphatase ≤ 2.5 x ULN, or ≤ 5 x ULN if known hepatic or bone&#xD;
                  metastases&#xD;
&#xD;
         10. Female patients with a negative pregnancy test result at screening and baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female patients pregnant or breast-feeding&#xD;
&#xD;
          2. Haematological malignancies or other secondary malignancy, that is currently&#xD;
             clinically significant or requires active intervention&#xD;
&#xD;
          3. Known untreated or symptomatic brain metastases&#xD;
&#xD;
          4. Predominantly squamous non-small cell lung carcinoma&#xD;
&#xD;
          5. Anti-tumour treatment within 4 weeks of the first infusion of MP0250, such as&#xD;
             chemotherapy, experimental or targeted therapy, biologics, hormonal therapy and&#xD;
             radiotherapy. The anti-tumour treatments below need longer wash-out periods and must&#xD;
             not be given within the indicated weeks of the first infusion of MP0250:&#xD;
&#xD;
             i. Nitrosoureas: 6 weeks ii. Monoclonal antibodies: 8 weeks&#xD;
&#xD;
          6. Exceptions: the following anti-tumour treatments are allowed as indicated i.&#xD;
             Palliative radiation to bone metastases to relieve bone pain ii. Standard of care&#xD;
             treatment such as bone modifying agents (i.e. bisphosphonates), denosumab, maintenance&#xD;
             hormonal therapy for metastatic prostate and breast cancers, hormone-replacement&#xD;
             therapy, and oral contraceptives&#xD;
&#xD;
          7. Presence of residual toxicities of CTC-AE Grade ≥ 2 after prior anti-tumour therapy at&#xD;
             screening. Except meeting other exclusion criteria, grade 1 toxicities related to&#xD;
             previous treatments are acceptable at the time of the first infusion of MP0250, as&#xD;
             well as Grade 2 alopecia&#xD;
&#xD;
          8. Exclusion criterion removed&#xD;
&#xD;
          9. Major surgical procedures, open biopsy or significant traumatic injury within 4 weeks&#xD;
             of first dose or anticipation of major surgical procedure during the course of the&#xD;
             study, core biopsy or minor surgical procedures within 1 week of first dose&#xD;
&#xD;
         10. Serious non-healing wound, active ulcer or untreated bone fracture&#xD;
&#xD;
         11. Proteinuria at screening as defined by ≥ 1+ on urinalysis dipstick, confirmed by ≥ 1g&#xD;
             in 24h urinalysis&#xD;
&#xD;
         12. Uncontrolled hypertension or any other serious cardiovascular or cardiac condition as&#xD;
             judged by the investigator&#xD;
&#xD;
         13. Severe or uncontrolled renal insufficiency&#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>Study Site Barcelona</name>
      <address>
        <city>Barcelona</city>
        <state>Catalunya</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site St. Gallen</name>
      <address>
        <city>St. Gallen</city>
        <state>Saint Gallen</state>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site Cambridge</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site Oxford</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>June 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>August 6, 2019</last_update_submitted>
  <last_update_submitted_qc>August 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02194426
org study id: MP0250-CP101
secondary id: 2014-000366-21
nct id: NCT02194426
lead sponsor: 
has dmc: No
This research study is looking at a new DARPin® drug candidate, called MP0250. There is
      evidence from preclinical studies that MP0250 may be effective in the treatment of cancer.
      This is the first study of MP0250 in humans and its main purpose is to test its safety and
      tolerability in patients with cancer. This study will also examine how the drug is changed by
      and removed from the body and look for indicators that the drug may be effective against
      cancer. This study will test several different dose levels of the study drug to determine the
      safety and tolerability profile of the drug.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of patients with dose limiting toxicities
time frame: From the Day 0 (first infusion) up to 35 days
measure: Vital signs
time frame: From inclusion (week -4) up to week 56
measure: Frequency of adverse events
time frame: From inclusion up to week 56
measure: MP0250 plasma concentration-time profile
time frame: From Day 0 (first infusion) up to week 56
measure: Nature of dose limiting toxicities
time frame: From the Day 0 (first infusion) up to 35 days
measure: Nature of adverse events
time frame: From inclusion up to week 56
measure: Severity of adverse events
time frame: From inclusion up to week 56
measure: Blood chemistry values
time frame: From inclusion (week -4) up to week 56
measure: Haematology values
time frame: From inclusion (week -4) up to week 56
measure: Urine values
time frame: From inclusion (week -4) up to week 56
measure: Electrocardiogram measurements
time frame: From inclusion (week -4) up to week 56
measure: Pharmacokinetics parameters
time frame: From Day 0 (first infusion) up to week 56
measure: Incidence of anti-drug-antibodies
time frame: From the Day 0 (first infusion) up to week 56
measure: Titre of anti-drug-antibodies
time frame: From the Day 0 (first infusion) up to week 56
arm group label: MP0250
arm group type: Experimental
description: see section "intervention description" below
intervention type: Drug
intervention name: MP0250
description: Intravenous application by infusion of MP0250 at up to six dose levels, every other week for up to 24 infusions.
arm group label: MP0250
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Spain
country: Switzerland
country: United Kingdom
responsible party type: Sponsor