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/NCT06011291</url>
    </required_header>
    <id_info>
      <org_study_id>SYH2051-001</org_study_id>
      <nct_id>NCT06011291</nct_id>
    </id_info>
    <brief_title>A Study of SYH2051 Monotherapy in Advanced Solid Tumors or in Combination With Radiotherapy in Locally Advanced Head and Neck Cancer</brief_title>
    <official_title>A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYH2051 Monotherapy in Patients With Advanced Solid Tumors or in Combination With Radiotherapy in Patients With Locally Advanced Head and Neck Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CSPC ZhongQi Pharmaceutical Technology Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CSPC ZhongQi Pharmaceutical Technology Co., Ltd.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an open-label, multicenter, dose-escalation phase I study to evaluate the safety,&#xD;
        tolerability, pharmacokinetics, and preliminary antitumor efficacy of SYH2051 in patients&#xD;
        with advanced solid tumors or in combination with radiotherapy (RT) in patients with locally&#xD;
        advanced head and neck cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of dose-limiting toxicities (DLTs)</measure>
      <time_frame>31 days for Arm A and 11 weeks for Arm B</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of adverse events (AEs) and serious adverse events (SAEs)</measure>
      <time_frame>2 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum tolerated dose (MTD)(if any) or maximum administrated dose (MAD)</measure>
      <time_frame>up to 1 year</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Recommended phase 2 dose (RP2D) of SYH2051 in combination with RT</measure>
      <time_frame>2 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Phase Ia: Maximum Plasma Concentration (Cmax)</measure>
      <time_frame>1 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase Ia: Time to Maximum Plasma Concentration (Tmax)</measure>
      <time_frame>1 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase Ia: Area under the plasma concentration-time curve from time zero to time of last measurable concentration(AUC0-last)</measure>
      <time_frame>1 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase Ia: Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)</measure>
      <time_frame>1 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate (DCR)</measure>
      <time_frame>2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of locoregional control (DoLC)</measure>
      <time_frame>2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase Ib and Ic: Concentrations of SYH2051</measure>
      <time_frame>2 years</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">73</enrollment>
    <condition>Solid Tumors</condition>
    <condition>Head and Neck Cancer</condition>
    <arm_group>
      <arm_group_label>Arm A: SYH2051 monotherapy dose escalation in advanced solid tumors (Phase Ia)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm B: SYH2051+RT dose escalation in locally advanced head and neck cancer (Phase Ib)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm C: SYH2051+RT dose expansion in locally advanced head and neck cancer (Phase Ic)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SYH2051 tablets</intervention_name>
      <description>Arm A: Five dose levels will be administered sequentially. Arm B and C: Concurrently administered with RT, and 2 weeks adjuvant treatment after RT.</description>
      <arm_group_label>Arm A: SYH2051 monotherapy dose escalation in advanced solid tumors (Phase Ia)</arm_group_label>
      <arm_group_label>Arm B: SYH2051+RT dose escalation in locally advanced head and neck cancer (Phase Ib)</arm_group_label>
      <arm_group_label>Arm C: SYH2051+RT dose expansion in locally advanced head and neck cancer (Phase Ic)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Intensity-Modulated Radiation Therapy (IMRT)</intervention_name>
      <description>Radical or adjuvant radiotherapy</description>
      <arm_group_label>Arm B: SYH2051+RT dose escalation in locally advanced head and neck cancer (Phase Ib)</arm_group_label>
      <arm_group_label>Arm C: SYH2051+RT dose expansion in locally advanced head and neck cancer (Phase Ic)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥18 years old, male or female;&#xD;
  &#xD;
            2. Phase Ia: Patients with histologically or cytologically confirmed advanced solid&#xD;
               tumors, for whom there is no standard therapy available, or ineffective or intolerant&#xD;
               to standard therapy. Phase Ib/Ic: Patients with histologically or cytologically&#xD;
               confirmed locally advanced head and neck cancer suitable for radiotherapy alone;&#xD;
  &#xD;
            3. Eastern Collaborative Oncology Group (ECOG) Performance Status of 0~1;&#xD;
  &#xD;
            4. Patients in medical conditions to be able to receive radiotherapy (for phase Ib/Ic);&#xD;
  &#xD;
            5. Life expectancy of &gt;3 months;&#xD;
  &#xD;
            6. At least one measurable lesion (excluding patients in phase Ic combined with adjuvant&#xD;
               radiotherapy);&#xD;
  &#xD;
            7. Patients with adequate hematologic, hepatic, renal and coagulation function;&#xD;
  &#xD;
            8. Patients are not pregnant or lactating and required contraception;&#xD;
  &#xD;
            9. Patients who are willing to provide written informed consent form (ICF) before the&#xD;
               beginning of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any antineoplastic therapy such as chemotherapy, biologic therapy, endocrine therapy,&#xD;
               or immunotherapy within 4 weeks before the first dose of the study drug (or within 5&#xD;
               half-lives of other unmarketed study drugs, whichever is longer), except for the&#xD;
               following:&#xD;
  &#xD;
                 1. 6 weeks for Nitrosoureas or mitomycin C;&#xD;
  &#xD;
                 2. 2 weeks or five half-lives (whichever is longer) for oral fluorouracil and small&#xD;
                    molecule targeted drugs;&#xD;
  &#xD;
                 3. 2 weeks for Chinese herbal medicine with antineoplastic indications;&#xD;
  &#xD;
            2. Patients with previous (within 2 years before screening) or concurrent other&#xD;
               malignancies (only for phase Ib/Ic);&#xD;
  &#xD;
            3. Patients had undergone major organ surgery (excluding needle biopsies) within 4 weeks&#xD;
               before the first dose, with obvious trauma, or require elective surgery during the&#xD;
               study;&#xD;
  &#xD;
            4. Severe, non-healing fractures within 4 weeks before the first dose of the study drug;&#xD;
  &#xD;
            5. The adverse reactions of previous antineoplastic therapy have not recovered to ≤grade&#xD;
               1 as determined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0&#xD;
               criteria;&#xD;
  &#xD;
            6. Patients who had received treatment with any drug that is a medium or strong inhibitor&#xD;
               or inducer of cytochrome P450 (CYP) 3A4/5 enzyme activity within 2 weeks before&#xD;
               screening or need to continue receiving such drugs;&#xD;
  &#xD;
            7. Active brain metastases and/or carcinomatous meningitis;&#xD;
  &#xD;
            8. Concurrent serious and/or uncontrolled medical conditions at screening (e.g., severe&#xD;
               chronic obstructive pulmonary disease);&#xD;
  &#xD;
            9. History of severe cardiovascular disease;&#xD;
  &#xD;
           10. History of myopathy or raised creatine kinase (CK) &gt;5 times the upper limit of normal&#xD;
               (ULN);&#xD;
  &#xD;
           11. Known hypersensitivity or intolerance to any component of the study drug or its&#xD;
               excipients;&#xD;
  &#xD;
           12. History of autoimmune disease, immunodeficiency disease, including HIV testing&#xD;
               positive or other acquired, congenital immunodeficiency diseases, or organ&#xD;
               transplantation;&#xD;
  &#xD;
           13. Active hepatitis B virus, hepatitis C virus or active syphilis infection;&#xD;
  &#xD;
           14. Active dysphagia, malabsorption or other chronic gastrointestinal diseases or&#xD;
               conditions that may hamper compliance and/or absorption of the study drug;&#xD;
  &#xD;
           15. Other ineligibilities according to the investigator.&#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_contact>
      <last_name>Clinical Trials Information Group officer</last_name>
      <phone>86-0311-69085587</phone>
      <email>ctr-contact@cspc.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Clinical Trials Information Group</name>
        <address>
          <city>Shijiazhuang</city>
          <state>Hebei</state>
          <zip>050000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Clinical Trials Information Group officer</last_name>
        <phone>86-0311-69085587</phone>
        <email>ctr-contact@cspc.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Head and Neck Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT06011291
  org study id: SYH2051-001
  nct id: NCT06011291
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is an open-label, multicenter, dose-escalation phase I study to evaluate the safety,
        tolerability, pharmacokinetics, and preliminary antitumor efficacy of SYH2051 in patients
        with advanced solid tumors or in combination with radiotherapy (RT) in patients with locally
        advanced head and neck cancer.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of dose-limiting toxicities (DLTs)
  time frame: 31 days for Arm A and 11 weeks for Arm B
  measure: Incidence of adverse events (AEs) and serious adverse events (SAEs)
  time frame: 2 years
  measure: Maximum tolerated dose (MTD)(if any) or maximum administrated dose (MAD)
  time frame: up to 1 year
  measure: Recommended phase 2 dose (RP2D) of SYH2051 in combination with RT
  time frame: 2 years
  measure: Phase Ia: Maximum Plasma Concentration (Cmax)
  time frame: 1 years
  measure: Phase Ia: Time to Maximum Plasma Concentration (Tmax)
  time frame: 1 years
  measure: Phase Ia: Area under the plasma concentration-time curve from time zero to time of last measurable concentration(AUC0-last)
  time frame: 1 years
  measure: Phase Ia: Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
  time frame: 1 years
  measure: Objective response rate (ORR)
  time frame: 2 years
  measure: Disease Control Rate (DCR)
  time frame: 2 years
  measure: Duration of locoregional control (DoLC)
  time frame: 2 years
  measure: Phase Ib and Ic: Concentrations of SYH2051
  time frame: 2 years
  arm group label: Arm A: SYH2051 monotherapy dose escalation in advanced solid tumors (Phase Ia)
  arm group type: Experimental
  arm group label: Arm B: SYH2051+RT dose escalation in locally advanced head and neck cancer (Phase Ib)
  arm group type: Experimental
  arm group label: Arm C: SYH2051+RT dose expansion in locally advanced head and neck cancer (Phase Ic)
  arm group type: Experimental
  intervention type: Drug
  intervention name: SYH2051 tablets
  description: Arm A: Five dose levels will be administered sequentially. Arm B and C: Concurrently administered with RT, and 2 weeks adjuvant treatment after RT.
  arm group label: Arm A: SYH2051 monotherapy dose escalation in advanced solid tumors (Phase Ia)
  arm group label: Arm B: SYH2051+RT dose escalation in locally advanced head and neck cancer (Phase Ib)
  arm group label: Arm C: SYH2051+RT dose expansion in locally advanced head and neck cancer (Phase Ic)
  intervention type: Radiation
  intervention name: Intensity-Modulated Radiation Therapy (IMRT)
  description: Radical or adjuvant radiotherapy
  arm group label: Arm B: SYH2051+RT dose escalation in locally advanced head and neck cancer (Phase Ib)
  arm group label: Arm C: SYH2051+RT dose expansion in locally advanced head and neck cancer (Phase Ic)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clinical Trials Information Group officer
  phone: 86-0311-69085587
  email: ctr-contact@cspc.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Head and Neck Neoplasms