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/NCT05973149</url>
    </required_header>
    <id_info>
      <org_study_id>QLH12016-101</org_study_id>
      <nct_id>NCT05973149</nct_id>
    </id_info>
    <brief_title>Trial of QLH12016 in Patients With Metastatic Castration Resistant Prostate Cancer</brief_title>
    <official_title>Tolerance, Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of QLH12016 in Patients With Metastatic Castration Resistant Prostate Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qilu Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Qilu Pharmaceutical Co., Ltd.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To evaluate the tolerance, safety, pharmacokinetics, and preliminary anti-tumor activity of&#xD;
        QLH12016 in patients with metastatic castration resistant prostate cancer&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Subjects will use QLH12016 for the treatment of mCRPC.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2025</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>Arm A： Incidence of Dose Limiting Toxicities</measure>
      <time_frame>28 Days</time_frame>
      <description>First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Arm A：Maximum Tolerated Dose</measure>
      <time_frame>28 Days</time_frame>
      <description>The Maximum Tolerated Dose determined by the Incidence of Dose Limiting Toxicities</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Arm A：Recommended Phase 2 Dose</measure>
      <time_frame>28 Days</time_frame>
      <description>Recommended Phase 2 Dose determined by the frequency of Incidence of Dose Limiting Toxicities</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Arm A：AE</measure>
      <time_frame>20 weeks</time_frame>
      <description>The incidence, severity and correlation with the study drug of adverse events (AEs) evaluated according to the National Cancer Institute (NCI) - General Terminology of Adverse Events (CTCAE) Version 5.0</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Arm A：SAE</measure>
      <time_frame>20 weeks</time_frame>
      <description>The incidence, severity and correlation with the study drug of Serious adverse event (SAE) evaluated according to the National Cancer Institute (NCI) - General Terminology of Adverse Events (CTCAE) Version 5.0</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Arm B-D：PSA Response Rate</measure>
      <time_frame>20 weeks</time_frame>
      <description>a decrease of ≥ 50% in PSA levels from baseline to baseline, and reassessed PSA relief after ≥ 3 weeks in each arm</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Arm B-D：Objective Response Rate</measure>
      <time_frame>20 weeks</time_frame>
      <description>the percentage of &quot;CR/PR&quot; subjects in each arm</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cmax</measure>
      <time_frame>20 weeks</time_frame>
      <description>The highest plasma drug concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax</measure>
      <time_frame>20 weeks</time_frame>
      <description>The time blood drug concentration reaching Cmax</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC</measure>
      <time_frame>20 weeks</time_frame>
      <description>The area enclosed by the drug time curve and the time axis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Arm A：ORR</measure>
      <time_frame>20 weeks</time_frame>
      <description>the percentage of &quot;CR/PR&quot; subjects</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Arm A：PSA Response Rate</measure>
      <time_frame>20 weeks</time_frame>
      <description>a decrease of ≥ 50% in PSA levels from baseline to baseline, and reassessed PSA relief after ≥ 3 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Arm B-D：AE</measure>
      <time_frame>20 weeks</time_frame>
      <description>The incidence, severity and correlation with the study drug of adverse events (AEs) evaluated according to the National Cancer Institute (NCI) - General Terminology of Adverse Events (CTCAE) Version 5.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Arm B-D：SAE</measure>
      <time_frame>20 weeks</time_frame>
      <description>The incidence, severity and correlation with the study drug of Serious adverse event (SAE) evaluated according to the National Cancer Institute (NCI) - General Terminology of Adverse Events (CTCAE) Version 5.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DOR</measure>
      <time_frame>20 weeks</time_frame>
      <description>The time between the initial evaluation of CR or PR and disease progression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DCR</measure>
      <time_frame>20 weeks</time_frame>
      <description>the percentage of &quot;CR/PR/SD&quot; subjects</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>rPFS</measure>
      <time_frame>20 weeks</time_frame>
      <description>The time between the first administration of the investigational drug and the first recording of disease progression (determined according to RECIST v1.1 and PCWG3) or the date of all-cause death (whichever occurs first)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>OS</measure>
      <time_frame>20 weeks</time_frame>
      <description>The time between the first trial drug administration and patient death due to various reasons</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Biomarkers</measure>
      <time_frame>20 weeks</time_frame>
      <description>Using next-generation sequencing，reverse transcription DNA and quantitative polymerase chain reaction to evaluate tumor mutational burden and other signal pathway indicators</description>
    </other_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">108</enrollment>
    <condition>Prostate Cancer</condition>
    <arm_group>
      <arm_group_label>QLH12016 dose escalation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Daily dosages are predetermined by Safety Monitoring Committee after the initial starting dose cohort at the end of Cycle 1 (each cycle is 28 days)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>QLH12016 in mCRPC with specific biomarkers</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Daily dosage and schedule at a recommended Phase 2 dose based on data from Arm A</description>
    </arm_group>
    <arm_group>
      <arm_group_label>QLH12016 in mCRPC without specific biomarkers</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Daily dosage and schedule at a recommended Phase 2 dose based on data from Arm A</description>
    </arm_group>
    <arm_group>
      <arm_group_label>QLH12016 in less pretreated mCRPC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Daily dosage and schedule at a recommended Phase 2 dose based on data from Arm A</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>QLH12016</intervention_name>
      <description>according to the scheme description</description>
      <arm_group_label>QLH12016 dose escalation</arm_group_label>
      <arm_group_label>QLH12016 in less pretreated mCRPC</arm_group_label>
      <arm_group_label>QLH12016 in mCRPC with specific biomarkers</arm_group_label>
      <arm_group_label>QLH12016 in mCRPC without specific biomarkers</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Voluntarily participate and sign a written informed consent form&#xD;
  &#xD;
            2. Male, aged ≥ 18 years&#xD;
  &#xD;
            3. ECOG：0-1&#xD;
  &#xD;
            4. Expected survival time of at least 3 months&#xD;
  &#xD;
            5. Prostate adenocarcinoma confirmed by histological or cytological without&#xD;
               neuroendocrine or small cell characters&#xD;
  &#xD;
            6. Continuous treatment with luteinizing hormone releasing hormone analogue or&#xD;
               luteinizing hormone releasing hormone antagonist (drug castration), or previous&#xD;
               bilateral orchiectomy (surgical castration); Subjects who did not receive bilateral&#xD;
               orchiectomy must plan to maintain effective luteinizing hormone releasing hormone&#xD;
               analog or luteinizing hormone releasing hormone antagonist treatment throughout the&#xD;
               study period&#xD;
  &#xD;
            7. testosterone≤50 ng/dL or 1.7 nmol/L&#xD;
  &#xD;
            8. CRPC is defined as the occurrence of one or more of the following three events in a&#xD;
               subject while undergoing castration treatment: ① PSA progression, defined as at least&#xD;
               two increases in PSA levels (PSA value&gt;1 ng/mL, interval of at least 1 week,&#xD;
               consecutive 2 times, increase&gt;50% from baseline); ② Disease progression as defined in&#xD;
               RECIST v1.1; ③ The progression of skeletal diseases as defined by the PCWG3 standard,&#xD;
               where bone scans reveal ≥ 2 or more new lesions&#xD;
  &#xD;
            9. Metastatic lesion with imaging evidence. At least one target lesion exists&#xD;
  &#xD;
           10. Received 1-2 lines of new endocrine therapy (such as enzalutamide, abiolone, etc.)&#xD;
               after developing castration resistance（ArmA-C）&#xD;
  &#xD;
           11. Received 0-1 line chemotherapy treatment (such as docetaxel) during the hormone&#xD;
               sensitive period and the castration resistance period（ArmA-C）&#xD;
  &#xD;
           12. Arm B: with specific biomarkers; Arm C: without specific biomarkers; Arm D: received 0&#xD;
               or 1 line of new endocrine therapy, and no chemotherapy during hormone sensitive and&#xD;
               castration resistant stages&#xD;
  &#xD;
           13. The functional level of important organs must meet the following requirements (no&#xD;
               blood components, hematopoietic stimulating factors, cell growth factors, leukemic&#xD;
               drugs, platelet enhancing drugs, etc. are allowed to be used within 7 days before&#xD;
               obtaining laboratory examination): Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelets&#xD;
               ≥ 100 × 10^9/L; Hemoglobin ≥ 100 g/L; Serum albumin ≥ 30 g/L; AST and ALT ≤ 2.5 ×&#xD;
               Upper limit of normal reference value (ULN), if accompanied by liver metastasis, ALT&#xD;
               and AST ≤ 5 × ULN; Total bilirubin ≤ 1.5 × ULN (Gilbert syndrome≤ 3 × ULN); Serum&#xD;
               creatinine ≤ 1.5 × ULN, if &gt;1.5 × ULN, then the creatinine clearance rate (CLcr) ≥ 50&#xD;
               mL/min; LVEF&gt;50%&#xD;
  &#xD;
           14. Effective contraceptive measures from signing the informed consent to 90 days after&#xD;
               the last use of the study drug&#xD;
  &#xD;
           15. Recover from all AEs of previous anti-cancer treatment (i.e. ≤ grade 1, according to&#xD;
               CTCAE v5.0), excluding alopecia (any grade) and peripheral sensory nerve ≤ grade 2,&#xD;
               hypomagnesemia or lymphocytopenia, as well as other abnormalities that the benefit of&#xD;
               receiving treatment is greater than the risk&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Metastasis of the central nervous system (CNS), leptomeningeal metastasis or spinal&#xD;
               cord compression caused by metastasis (exceeding the physiological alternative dose)&#xD;
               requiring hormone treatment&#xD;
  &#xD;
            2. Radiation therapy that has irradiated more than 25% of the bone marrow was performed&#xD;
               within 4 weeks. Palliative radiation therapy is allowed to alleviate pain caused by&#xD;
               bone metastasis during the study period&#xD;
  &#xD;
            3. Treatment with similar drugs&#xD;
  &#xD;
            4. Received other clinical trial drugs or major surgeries within 4 weeks (sufficient&#xD;
               wound healing after major surgeries must undergo clinical evaluation)&#xD;
  &#xD;
            5. Systemic anti-cancer treatment within the first 2 weeks (bicalutamide, Mitomycin C or&#xD;
               Nitroso urea 6 weeks, enzalutamide 5 weeks, and abiolone 4 weeks). Medications that&#xD;
               maintain castration are allowed.&#xD;
  &#xD;
            6. Planned bilateral orchiectomy during the study treatment&#xD;
  &#xD;
            7. Inability to swallow, chronic diarrhea and bowel obstruction, or other factors&#xD;
               affecting drug administration and absorption&#xD;
  &#xD;
            8. Epilepsy or disease that can induce seizure within 12 months (including a history of&#xD;
               transient ischemic attack, stroke, brain trauma with disorders of consciousness, etc.)&#xD;
  &#xD;
            9. History of psychotropic substance abuse, alcoholism, or drug use, neurological or&#xD;
               mental disorders, including dementia or hepatic encephalopathy&#xD;
  &#xD;
           10. Any of the following conditions occurs within 12 months: myocardial infarction,&#xD;
               severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic&#xD;
               congestive heart failure (New York Heart Association III or IV), cerebrovascular&#xD;
               accident, transient ischemic attack, symptomatic pulmonary embolism or other&#xD;
               thromboembolic diseases with clinical significance&#xD;
  &#xD;
           11. Any of the following conditions within 6 months: congenital long QT syndrome, torsade&#xD;
               de pointes ventricular tachycardia, arrhythmia (including persistent ventricular&#xD;
               tachyarrhythmia and Ventricular fibrillation), left anterior half block (double vessel&#xD;
               block) or persistent arrhythmia above NCI-CTCAE grade 2, Atrial fibrillation of any&#xD;
               level (in the case of Asymptomatic isolated Atrial fibrillation, grade ≥ 2)&#xD;
  &#xD;
           12. Cardiovascular diseases under poor control, including angina pectoris, pulmonary&#xD;
               hypertension or serious cardiac rhythm or conduction abnormalities&#xD;
  &#xD;
           13. QTcF&gt;450 ms&#xD;
  &#xD;
           14. Active, uncontrolled bacterial, fungal, or viral infections, including but not limited&#xD;
               to: 1) Active hepatitis B virus (HBV), hepatitis C virus (HCV) infected persons&#xD;
               (hepatitis B surface antigen [HBsAg] positive or hepatitis B core antibody [HBcAb]&#xD;
               positive, HBV DNA virus copy number ≥ 500 IU/mL, HCV antibody positive and HCV RNA&#xD;
               higher than the detection limit of the analysis method); 2) Syphilis required&#xD;
               treatment; 3) History of congenital immunodeficiency or organ transplantation, or HIV&#xD;
               (HIV) positive&#xD;
  &#xD;
           15. Clinically uncontrollable third space effusion, such as pleural effusion, peritoneal&#xD;
               effusion, pericardial effusion, etc. that cannot be controlled by drainage or other&#xD;
               measures and cannot be included in the group according to the judgment of the&#xD;
               investigator&#xD;
  &#xD;
           16. Other malignant tumors within 5 years (excluding cured basal cell skin cancer,&#xD;
               papillary thyroid cancer, etc.)&#xD;
  &#xD;
           17. Concomitant diseases seriously endangering the safety of the subject or affect the&#xD;
               completion of the study, such as hypertension (systolic pressure ≥ 160 mmHg and/or&#xD;
               diastolic pressure ≥ 100 mmHg) that cannot be controlled by two or more&#xD;
               antihypertensive drugs, diabetes not well controlled, etc&#xD;
  &#xD;
           18. History of hypertensive crisis or hypertensive encephalopathy&#xD;
  &#xD;
           19. Allergy to any study drug component&#xD;
  &#xD;
           20. Gastrointestinal perforation, gastrointestinal or non gastrointestinal fistula, or&#xD;
               abdominal abscess within 6 months&#xD;
  &#xD;
           21. Any life-threatening bleeding event within 3 months, including the need for blood&#xD;
               transfusion treatment, surgery or local treatment, and continuous medication treatment&#xD;
  &#xD;
           22. Subjects who may increase research related risks, interfere with the interpretation of&#xD;
               research results, or are deemed unsuitable for inclusion by the researcher&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zhisong He, Phd</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Urology, Peking University First Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hongqian Guo, Phd</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Urology, Drum Tower Hospital, Nanjing University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zhisong He, Phd</last_name>
      <phone>8613910688432</phone>
      <email>wyj7074@sohu.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Urology, Peking University First Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijign</state>
          <zip>100034</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Zhisong He, Phd</last_name>
        <phone>8613910688432</phone>
        <email>wyj7074@sohu.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Department of Urology, Drum Tower Hospital, Nanjing University School of Medicine</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210008</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hongqian Guo, Phd</last_name>
        <phone>8613605171690</phone>
        <email>dr.ghq@nju.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 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>Prostatic 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>
  
  
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/NCT05973149
  org study id: QLH12016-101
  nct id: NCT05973149
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the tolerance, safety, pharmacokinetics, and preliminary anti-tumor activity of
        QLH12016 in patients with metastatic castration resistant prostate cancer
  Subjects will use QLH12016 for the treatment of mCRPC.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Arm A： Incidence of Dose Limiting Toxicities
  time frame: 28 Days
  description: First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug
  measure: Arm A：Maximum Tolerated Dose
  time frame: 28 Days
  description: The Maximum Tolerated Dose determined by the Incidence of Dose Limiting Toxicities
  measure: Arm A：Recommended Phase 2 Dose
  time frame: 28 Days
  description: Recommended Phase 2 Dose determined by the frequency of Incidence of Dose Limiting Toxicities
  measure: Arm A：AE
  time frame: 20 weeks
  description: The incidence, severity and correlation with the study drug of adverse events (AEs) evaluated according to the National Cancer Institute (NCI) - General Terminology of Adverse Events (CTCAE) Version 5.0
  measure: Arm A：SAE
  time frame: 20 weeks
  description: The incidence, severity and correlation with the study drug of Serious adverse event (SAE) evaluated according to the National Cancer Institute (NCI) - General Terminology of Adverse Events (CTCAE) Version 5.0
  measure: Arm B-D：PSA Response Rate
  time frame: 20 weeks
  description: a decrease of ≥ 50% in PSA levels from baseline to baseline, and reassessed PSA relief after ≥ 3 weeks in each arm
  measure: Arm B-D：Objective Response Rate
  time frame: 20 weeks
  description: the percentage of "CR/PR" subjects in each arm
  measure: Cmax
  time frame: 20 weeks
  description: The highest plasma drug concentration
  measure: Tmax
  time frame: 20 weeks
  description: The time blood drug concentration reaching Cmax
  measure: AUC
  time frame: 20 weeks
  description: The area enclosed by the drug time curve and the time axis
  measure: Arm A：ORR
  time frame: 20 weeks
  description: the percentage of "CR/PR" subjects
  measure: Arm A：PSA Response Rate
  time frame: 20 weeks
  description: a decrease of ≥ 50% in PSA levels from baseline to baseline, and reassessed PSA relief after ≥ 3 weeks
  measure: Arm B-D：AE
  time frame: 20 weeks
  description: The incidence, severity and correlation with the study drug of adverse events (AEs) evaluated according to the National Cancer Institute (NCI) - General Terminology of Adverse Events (CTCAE) Version 5.0
  measure: Arm B-D：SAE
  time frame: 20 weeks
  description: The incidence, severity and correlation with the study drug of Serious adverse event (SAE) evaluated according to the National Cancer Institute (NCI) - General Terminology of Adverse Events (CTCAE) Version 5.0
  measure: DOR
  time frame: 20 weeks
  description: The time between the initial evaluation of CR or PR and disease progression
  measure: DCR
  time frame: 20 weeks
  description: the percentage of "CR/PR/SD" subjects
  measure: rPFS
  time frame: 20 weeks
  description: The time between the first administration of the investigational drug and the first recording of disease progression (determined according to RECIST v1.1 and PCWG3) or the date of all-cause death (whichever occurs first)
  measure: OS
  time frame: 20 weeks
  description: The time between the first trial drug administration and patient death due to various reasons
  measure: Biomarkers
  time frame: 20 weeks
  description: Using next-generation sequencing，reverse transcription DNA and quantitative polymerase chain reaction to evaluate tumor mutational burden and other signal pathway indicators
  arm group label: QLH12016 dose escalation
  arm group type: Experimental
  description: Daily dosages are predetermined by Safety Monitoring Committee after the initial starting dose cohort at the end of Cycle 1 (each cycle is 28 days)
  arm group label: QLH12016 in mCRPC with specific biomarkers
  arm group type: Experimental
  description: Daily dosage and schedule at a recommended Phase 2 dose based on data from Arm A
  arm group label: QLH12016 in mCRPC without specific biomarkers
  arm group type: Experimental
  description: Daily dosage and schedule at a recommended Phase 2 dose based on data from Arm A
  arm group label: QLH12016 in less pretreated mCRPC
  arm group type: Experimental
  description: Daily dosage and schedule at a recommended Phase 2 dose based on data from Arm A
  intervention type: Drug
  intervention name: QLH12016
  description: according to the scheme description
  arm group label: QLH12016 dose escalation
  arm group label: QLH12016 in less pretreated mCRPC
  arm group label: QLH12016 in mCRPC with specific biomarkers
  arm group label: QLH12016 in mCRPC without specific biomarkers
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Zhisong He, Phd
  role: Principal Investigator
  affiliation: Department of Urology, Peking University First Hospital
  last name: Hongqian Guo, Phd
  role: Principal Investigator
  affiliation: Department of Urology, Drum Tower Hospital, Nanjing University School of Medicine
  last name: Zhisong He, Phd
  phone: 8613910688432
  email: wyj7074@sohu.com
  facility: 
  contact: 
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  sharing ipd: No