xml: <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/NCT06021626</url>
    </required_header>
    <id_info>
      <org_study_id>23-169</org_study_id>
      <nct_id>NCT06021626</nct_id>
    </id_info>
    <brief_title>A Study of CRD3874-SI in People With Sarcoma or Merkel Cell Cancer</brief_title>
    <official_title>A Phase I Trial of CRD3874-SI, a STING Agonist, in Patients With Advanced/Metastatic Sarcoma and Merkel Cell Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Memorial Sloan Kettering Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Curadev Pharma</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Memorial Sloan Kettering Cancer Center</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>
        This study will test the safety of a study drug called CRD3874-SI. The researchers will test&#xD;
        different doses of CRD3874-SI to find the highest dose that causes few or mild side effects&#xD;
        in participants. After the researchers find the highest safe dose of CRD3874-SI, they will&#xD;
        test that dose in new groups of participants to help them learn more about the side effects&#xD;
        of the study drug and find out whether CRD3874-SI is an effective treatment for Sarcoma and&#xD;
        Merkel Cell Cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 25, 2023</start_date>
    <completion_date type="Anticipated">August 2029</completion_date>
    <primary_completion_date type="Anticipated">August 2029</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>This is a single center, phase I study with escalation and expansion cohort.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>maximum tolerated dose (MTD)</measure>
      <time_frame>1 year</time_frame>
      <description>The MTD is defined as the highest dose level studied at which &lt;2 subjects out of 6 experience a DLT. A dose level under consideration as the MTD will be expanded to six patients if only three have been accrued.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>objective response rate (ORR) (Dose expansion)</measure>
      <time_frame>up to 48 weeks</time_frame>
      <description>by RECIST v1.1</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Sarcoma</condition>
    <condition>Merkel Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>CRD3874-SI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Phase 1a: starting dose of 0.1 mg/kg, Phase 1b: RP2D determined during Phase 1a. Cycle 1 &amp; 2: once weekly infusion x 4 (Days 1, 8, 15, 22) over 28-day cycle. Cycle 3 onwards: weekly infusion x 3 (Days 1, 8, 15) over 28-day cycle</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CRD3874</intervention_name>
      <description>Starting dose is 0.1 mg/kg for weekly IV infusion of CRD3874-SI.&#xD;
  Cohort CRD3874-SI Dose level (mg/kg)&#xD;
  0.1&#xD;
  0.3&#xD;
  0.9&#xD;
  1.8&#xD;
  2.7&#xD;
  4.05</description>
      <arm_group_label>CRD3874-SI</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female age ≥ 18 years at the time of informed consent.&#xD;
  &#xD;
            -  Be capable, willing, and able to provide written informed consent.&#xD;
  &#xD;
            -  Be willing to comply with clinical trial instructions and requirements, including&#xD;
               tumor biopsies (if feasible and required per protocol).&#xD;
  &#xD;
            -  Patients must have a locally advanced or metastatic cancer that has progressed on at&#xD;
               least one line of systemic therapy or for which no standard treatment is available, or&#xD;
               the participant is intolerant to available treatment.&#xD;
  &#xD;
            -  In the dose escalation phase study patients must have a histologically or&#xD;
               cytologically confirmed sarcoma of any subtype or merkel cell carcinoma that has&#xD;
               progressed on anti-PD-1/-PD-L1 monoclonal antibody treatment.&#xD;
  &#xD;
            -  In the dose expansion phase patients must have a histologically or cytologically&#xD;
               confirmed antiPD1/PD-L1 undifferentiated pleomorphic sarcoma or myxofibrosarcoma,&#xD;
               angiosarcoma, or bone sarcoma or merkel cell carcinoma. Patients with UPS/MFS,&#xD;
               angiosarcoma and MCC must have progressed on or be refractory to anti-PD-1/anti-PD-L1&#xD;
               therapy.&#xD;
  &#xD;
            -  In the dose escalation phase an upper bound weight limit restriction will be used for&#xD;
               dose levels 5 and 6. Hence, patients must weight ≤90kg and ≤70kg in order to be&#xD;
               eligible to enroll in dose level 5 and 6 of the dose escalation phase, respectively.&#xD;
  &#xD;
            -  Adequate performance status: ECOG 0 or 1/KPS 100-70%.&#xD;
  &#xD;
            -  Life expectancy of at least three months after the first CRD3874 infusion, according&#xD;
               to the Investigator's opinion&#xD;
  &#xD;
            -  Presence of measurable disease per RECIST v1.1.Target lesion(s) must not be chosen&#xD;
               from a previously irradiated field unless there has been radiographically and/or&#xD;
               pathologically documented tumor progression in that lesion prior to enrollment.&#xD;
  &#xD;
            -  In the dose expansion phase , participants must agree to have a pretreatment tumor&#xD;
               biopsy for research purposes. Participants in whom biopsy is technically not feasible&#xD;
               or in whom the associated procedure would result in unacceptable risk, in the opinion&#xD;
               of the Investigator, or patients who do not wish to have a biopsy, archival tissue&#xD;
               (most recently procured sample where tissue is available) may be used instead, if&#xD;
               available.&#xD;
  &#xD;
            -  In the dose expansion phase , participants must agree to on-treatment tumor biopsy for&#xD;
               research purposes. Participants in whom biopsy is technically not feasible or in whom&#xD;
               would result in unacceptable risk, in the opinion of the Investigator, or patients who&#xD;
               do not wish to have a biopsy- may be exempted from the biopsy requirement with&#xD;
               discussion with the Principal Investigator .&#xD;
  &#xD;
            -  Female subject of childbearing potential (defined as a sexually mature female who has&#xD;
               not undergone a hysterectomy or bilateral oophorectomy or who has not been naturally&#xD;
               postmenopausal for at least 24 consecutive months) should have a negative serum&#xD;
               pregnancy testing at screening visit and within 72 hours prior to the first dose of&#xD;
               study medication.&#xD;
  &#xD;
            -  Adequate organ function determined within 14 days of treatment initiation, defined as&#xD;
               follows:&#xD;
  &#xD;
                 -  Hemoglobin ≥ 9.0 g/dL&#xD;
  &#xD;
                 -  Absolute neutrophil count ≥ 1,000/mm^3 (1.0 x 10^9/L)&#xD;
  &#xD;
                 -  Platelet count ≥ 100,000/mm3 (100 x 10^9 /L)&#xD;
  &#xD;
                 -  Serum bilirubin ≤ 1.2x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for&#xD;
                    participants with total bilirubin level &gt; 1.2x ULN&#xD;
  &#xD;
                 -  Aspartate aminotransferase (AST) ≤ 2.5x ULN OR ≤ 5x ULN for participants with&#xD;
                    liver metastases&#xD;
  &#xD;
                 -  Alanine aminotransferase (ALT) ≤ 2.5x ULN OR ≤ 5x ULN for participants with liver&#xD;
                    metastases&#xD;
  &#xD;
                 -  Albumin ≥ 2.5mg/dL.&#xD;
  &#xD;
                 -  Calculated creatinine clearance (CrCl) ≥ 60 mL/min by Cockcroft-Gault formula&#xD;
  &#xD;
                 -  International Normalized Ratio (INR) or prothrombin time (PT) ≤1.5x ULN unless&#xD;
                    participant is receiving anticoagulant therapy as long as PT or partial&#xD;
                    thromboplastin time (PTT) is within therapeutic range of intended use of&#xD;
                    anticoagulants.&#xD;
  &#xD;
                 -  Activated partial thromboplastin time (aPTT) ≤ 1.5x ULN unless participant is&#xD;
                    receiving anticoagulant therapy as long as PT and PTT is within therapeutic range&#xD;
                    of intended use of anticoagulants&#xD;
  &#xD;
                 -  Left ventricular ejection fraction (LVEF) &gt; 50%, as measured by echocardiogram&#xD;
                    (2D-ECHO) or multi-gated acquisition scan (MUGA)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known prior severe hypersensitivity to an investigational product or any component of&#xD;
               the study drug therapy's formulations including polyethylene glycol (PEG), (NCI CTCAE&#xD;
               v5.0 Grade ≥ 3)&#xD;
  &#xD;
            -  Evidence of clinically significant immunosuppression such as the following:&#xD;
  &#xD;
                 -  Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease&#xD;
  &#xD;
                 -  Concurrent opportunistic infection&#xD;
  &#xD;
                 -  Receiving systemic immunosuppressive therapy (&gt; 2 weeks) including oral steroid&#xD;
                    doses &gt; 10 mg/day of prednisone or equivalent within 7 days prior to enrollment.&#xD;
                    In the setting of non-immune mediated indications for use, chronic/active low&#xD;
                    dose steroid (equivalent to &lt;/=10mg/day prednisone) use may be permitted at the&#xD;
                    discretion of the principal investigator.&#xD;
  &#xD;
                 -  Current use of immunosuppressive medication, EXCEPT for the following:&#xD;
  &#xD;
          I. Intranasal, inhaled, ocular, topical steroids, or local steroid injection (e.g.,&#xD;
          intraarticular injection) II. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of&#xD;
          prednisone or equivalent III. Steroids as premedication for hypersensitivity reactions&#xD;
          (e.g., CT scan premedication)&#xD;
  &#xD;
            -  Prior organ transplantation, including allogenic stem-cell transplantation.&#xD;
               Consideration will be given to allow patients with a history of autologous&#xD;
               transplantation enroll if they are at least 5 years beyond the completion of the&#xD;
               transplant pending discussion with the principal investigator.&#xD;
  &#xD;
            -  History or evidence of symptomatic autoimmune disease (e.g., pneumonitis,&#xD;
               glomerulonephritis, vasculitis, or other), or history of active autoimmune disease&#xD;
               that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive&#xD;
               drugs or biological agents used for treatment of autoimmune diseases) in past 2 years&#xD;
               prior to enrollment. Replacement therapy (e.g., thyroxine for hypothyroidism, insulin&#xD;
               for diabetes or physiologic corticosteroid replacement therapy for adrenal or&#xD;
               pituitary insufficiency) is not considered a form of systemic treatment for autoimmune&#xD;
               disease.&#xD;
  &#xD;
            -  Systemic antibiotics received ≥ 7 days prior to the first dose of study drugs.&#xD;
  &#xD;
            -  Uncontrolled medical condition including current active infection requiring systemic&#xD;
               therapy or symptomatic congestive heart failure within 6 months that in the&#xD;
               investigators opinion compromise the ability of the patient to complete all study&#xD;
               related requirements safely&#xD;
  &#xD;
            -  Inability to comply with protocol required procedures&#xD;
  &#xD;
            -  Mean resting corrected QT interval ≥ 470 ms on a 12-lead electrocardiogram (ECG) for&#xD;
               males and females&#xD;
  &#xD;
            -  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 4 weeks of the first dose of treatment or 5 half-lives, if shorter.&#xD;
  &#xD;
            -  Has had prior chemotherapy or targeted small molecule therapy within 3 weeks,&#xD;
               anti-cancer monoclonal antibody (mAb) within 4 weeks or OR 5 half-lives, if shorter,&#xD;
               or radiation therapy within 2 weeks prior to the first CRD3874 infusion prior to study&#xD;
               Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events&#xD;
               due to a previously administered agent&#xD;
  &#xD;
                 -  Note: Alopecia or other Grade ≤ 2 not constituting a safety risk based on&#xD;
                    investigator's judgment are acceptable&#xD;
  &#xD;
                 -  Note: If patient received major surgery, they must have recovered adequately from&#xD;
                    the toxicity and/or complications from the intervention prior to starting study&#xD;
                    therapy&#xD;
  &#xD;
            -  Evidence of clinically significant interstitial lung disease, history of interstitial&#xD;
               lung disease, or active, noninfectious pneumonitis related to prior immunotherapy&#xD;
               treatment.&#xD;
  &#xD;
            -  History of unstable or deteriorating cardiovascular disease within the previous 6&#xD;
               months prior to screening including but not limited to the following:&#xD;
  &#xD;
                 -  Unstable angina or myocardial infarction&#xD;
  &#xD;
                 -  CVA/stroke&#xD;
  &#xD;
                 -  Congestive heart failure (New York Heart Association [NYHA] Class III or IV&#xD;
  &#xD;
                 -  Uncontrolled clinically significant arrhythmias.&#xD;
  &#xD;
            -  Has known active central nervous system (CNS) metastases and/or carcinomatous&#xD;
               meningitis.&#xD;
  &#xD;
            -  Patients with previously treated brain metastases or carcinomatous meningitis may&#xD;
               participate provided they are stable (without evidence of progression by imaging for&#xD;
               at least four weeks prior to the first dose of trial treatment and any neurologic&#xD;
               symptoms have returned to baseline), have no evidence of new or enlarging brain&#xD;
               metastases, and are not using steroids for at least 7 days prior to trial treatment.&#xD;
  &#xD;
            -  Has received a live vaccine within 30 days of the planned start of study drug. Note:&#xD;
               Seasonal influenza vaccines for injection are generally inactivated flu vaccines and&#xD;
               are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live&#xD;
               attenuated vaccines, and are not allowed.&#xD;
  &#xD;
            -  Patients known to be positive for active Hepatitis B (HBsAg reactive with detectable&#xD;
               HBV DNA), or Hepatitis C (HCV RNA (qualitative) is detected)&#xD;
  &#xD;
                 1. Patients with chronic hepatitis B (positive HBsAg and/or HBcAb and negative HBV&#xD;
                    DNA by PCR) are eligible for this study if they are on suppressive anti-viral&#xD;
                    therapy and deemed safe by a gastroenterologist&#xD;
  &#xD;
                 2. Patient who is HCV Ab positive but HCV RNA negative due to prior treatment or&#xD;
                    natural resolution will be considered eligible.&#xD;
  &#xD;
            -  Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies) disease that&#xD;
               is not controlled. Note HIV-positive patients will be considered eligible if:&#xD;
  &#xD;
                 -  Established ART for at least four weeks and have an HIV viral load less than 400&#xD;
                    copies/mL prior to enrollment&#xD;
  &#xD;
                 -  CD4+ T-cell (CD4+) counts ≥ 350 cells/uL&#xD;
  &#xD;
                 -  No opportunistic infection within the past 12 months&#xD;
  &#xD;
                 -  Has a known history of active TB (Bacillus Tuberculosis)&#xD;
  &#xD;
            -  Women who are pregnant or breastfeeding&#xD;
  &#xD;
            -  Patients expecting to conceive or father children within the projected duration of the&#xD;
               trial, starting with the pre-screening or screening visit through three months after&#xD;
               the last dose of study treatment(s).&#xD;
  &#xD;
            -  Female participants of childbearing potential and male participants who are unwilling&#xD;
               to use acceptable method(s) of effective contraception during study treatment and&#xD;
               until six months for female and three months for males after the last dose of&#xD;
               CRD3874-SI. Abstinence is acceptable if this is the usual lifestyle and preferred&#xD;
               contraception for the participant.&#xD;
  &#xD;
          (Note: Women not of childbearing potential are defined as: Any female who is postmenopausal&#xD;
          [age &gt; 55 years with cessation of menses for 12 or more months or less than 55 years but&#xD;
          with no spontaneous menses for at least two years or less than 55 years and spontaneous&#xD;
          menses within the past one year but currently amenorrheic (e.g., spontaneous or secondary&#xD;
          to hysterectomy) and with postmenopausal gonadotropin levels (luteinizing hormone and&#xD;
          follicle-stimulating hormone levels &gt; 40 IU/L) or postmenopausal estradiol levels (&lt; 5&#xD;
          ng/dL) or according to the definition of &quot;postmenopausal range&quot; for the laboratory&#xD;
          involved] or who have had a hysterectomy, bilateral salpingectomy, or bilateral&#xD;
          oophorectomy.)&#xD;
  &#xD;
            -  The presence of a concurrent active malignancy that in the opinion of the investigator&#xD;
               could compromise the conduct of the study or interfere with determining the outcomes&#xD;
               of the study objectives.&#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>Ciara Kelly, MBBCH BAO</last_name>
      <role>Principal Investigator</role>
      <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ciara Kelly, MBBChBAO</last_name>
      <phone>646-888-4312</phone>
      <email>zzPDL_MED_Sarcoma_Clinical_Trials &lt;zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org&gt;</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sandra D'Angelo</last_name>
      <phone>646-888-4159</phone>
      <email>zzPDL_MED_Sarcoma_Clinical_Trials &lt;zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org&gt;</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)</name>
        <address>
          <city>Basking Ridge</city>
          <state>New Jersey</state>
          <zip>07920</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ciara Kelly, MBBCH BAO</last_name>
        <phone>646-888-4312</phone>
        <email>zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Monmouth (Limited Protocol Activities)</name>
        <address>
          <city>Middletown</city>
          <state>New Jersey</state>
          <zip>07748</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ciara Kelly, MBBCH BAO</last_name>
        <phone>646-888-4312</phone>
        <email>zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Bergen (Limited Protocol Activities)</name>
        <address>
          <city>Montvale</city>
          <state>New Jersey</state>
          <zip>07645</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ciara Kelly, MBBCH BAO</last_name>
        <phone>646-888-4312</phone>
        <email>zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)</name>
        <address>
          <city>Commack</city>
          <state>New York</state>
          <zip>11725</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ciara Kelly, MBBCH BAO</last_name>
        <phone>646-888-4312</phone>
        <email>zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Westchester (Limited Protocol Activities)</name>
        <address>
          <city>Harrison</city>
          <state>New York</state>
          <zip>10604</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ciara Kelly, MBBCH BAO</last_name>
        <phone>646-888-4312</phone>
        <email>zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center (All Protocol Activities)</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10065</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ciara Kelly, MBBCh BAO</last_name>
        <phone>646-888-4312</phone>
        <email>zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org</email>
      </contact>
      <investigator>
        <last_name>Ciara Kelly, MBBCh BAO</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Nassau (Limited Protocol Activities)</name>
        <address>
          <city>Rockville Centre</city>
          <state>New York</state>
          <zip>11553</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ciara Kelly, MBBCH BAO</last_name>
        <phone>646-888-4312</phone>
        <email>zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
      <description>Memorial Sloan Kettering Cancer Center</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>CRD3874-SI</keyword>
    <keyword>23-169</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma, Merkel Cell</mesh_term>
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Sarcoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021626
  org study id: 23-169
  nct id: NCT06021626
  lead sponsor: 
  collaborator: 
  is fda regulated drug: Yes
  is fda regulated device: No
  This study will test the safety of a study drug called CRD3874-SI. The researchers will test
        different doses of CRD3874-SI to find the highest dose that causes few or mild side effects
        in participants. After the researchers find the highest safe dose of CRD3874-SI, they will
        test that dose in new groups of participants to help them learn more about the side effects
        of the study drug and find out whether CRD3874-SI is an effective treatment for Sarcoma and
        Merkel Cell Cancer.
  allocation: N/A
  intervention model: Sequential Assignment
  intervention model description: This is a single center, phase I study with escalation and expansion cohort.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: maximum tolerated dose (MTD)
  time frame: 1 year
  description: The MTD is defined as the highest dose level studied at which <2 subjects out of 6 experience a DLT. A dose level under consideration as the MTD will be expanded to six patients if only three have been accrued.
  measure: objective response rate (ORR) (Dose expansion)
  time frame: up to 48 weeks
  description: by RECIST v1.1
  arm group label: CRD3874-SI
  arm group type: Experimental
  description: Phase 1a: starting dose of 0.1 mg/kg, Phase 1b: RP2D determined during Phase 1a. Cycle 1 & 2: once weekly infusion x 4 (Days 1, 8, 15, 22) over 28-day cycle. Cycle 3 onwards: weekly infusion x 3 (Days 1, 8, 15) over 28-day cycle
  intervention type: Drug
  intervention name: CRD3874
  description: Starting dose is 0.1 mg/kg for weekly IV infusion of CRD3874-SI.
  Cohort CRD3874-SI Dose level (mg/kg)
  0.1
  0.3
  0.9
  1.8
  2.7
  4.05
  arm group label: CRD3874-SI
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ciara Kelly, MBBCH BAO
  role: Principal Investigator
  affiliation: Memorial Sloan Kettering Cancer Center
  last name: Ciara Kelly, MBBChBAO
  phone: 646-888-4312
  email: zzPDL_MED_Sarcoma_Clinical_Trials <zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org>
  last name: Sandra D'Angelo
  phone: 646-888-4159
  email: zzPDL_MED_Sarcoma_Clinical_Trials <zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org>
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: http://www.mskcc.org/mskcc/html/44.cfm
  description: Memorial Sloan Kettering Cancer Center
  responsible party type: Sponsor
  mesh term: Carcinoma, Merkel Cell
  mesh term: Carcinoma
  mesh term: Sarcoma
  sharing ipd: Yes
  ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.