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/NCT06037317</url>
    </required_header>
    <id_info>
      <org_study_id>CT-3505-I-03</org_study_id>
      <nct_id>NCT06037317</nct_id>
    </id_info>
    <brief_title>Phase Ib Study of SY-3505 in Patients With Advanced LTK Fusion-Positive Solid Tumors</brief_title>
    <official_title>A Phase Ib, Multi-center, Open-Lable, Dose-Escalation and Dose-Expansion Study of Efficacy and Safety of SY-3505 in Patients With Advanced LTK Fusion-Positive Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shouyao Holdings (Beijing) Co. LTD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shouyao Holdings (Beijing) 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>
        This is an open-label, single-arm, multicenter, phase Ib study to evaluate the efficacy and&#xD;
        safety of SY-3505 capsule in patients with locally advanced or metastatic, LTK&#xD;
        fusion-positive solid tumor who have progressed on or are intolerant to prior standard&#xD;
        therapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be conducted in 2 parts:&#xD;
  &#xD;
        Dose-escalation phase: Participants will be allocated to one of the three dose groups of&#xD;
        500mg, 600mg, or 800mg and receive a single dose of SY-3505 capsules, followed by a 7-day&#xD;
        safety observation period and pharmacokinetic (PK) assessment. Subsequently, SY-3505 will be&#xD;
        administered once daily in 28-day treatment cycles. This phase is designed to determine the&#xD;
        DLTs (Dose-limiting toxicity) and recommended phase II dose (RP2D) and characterize the&#xD;
        safety, tolerability and PK of SY-3505 in patients with LTK fusion-positive solid tumors.&#xD;
  &#xD;
        Dose-expansion phase: Participants will be assigned to one of the 1-2 dose groups determined&#xD;
        during the dose-escalation phase, and receive SY-3505 capsules once daily in 28-day treatment&#xD;
        cycles. This phase is designed to evaluate the anti-tumor activity (ORR, DCR and DOR) of&#xD;
        SY-3505 in patients with LTK fusion-positive solid tumors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">October 30, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
    <phase>Phase 1</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>Incidence of adverse events (AEs)</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Characterization of the safety and tolerability</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of dose limiting toxicities (DLTs)</measure>
      <time_frame>Escalation Cycle 1 (28 days)</time_frame>
      <description>Maximum Tolerated Dose (MTD) and/or recommended phase 2 dose (RP2D) in Cycle 1</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics (Cmax) for SY-3505</measure>
      <time_frame>Protocol-defined time points during Cycle 1 and 2 of treatment (each cycle is 28 days)</time_frame>
      <description>Defined as maximum observed plasma concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics (Tmax) for SY-3505</measure>
      <time_frame>Protocol-defined time points during Cycle 1 and 2 of treatment (each cycle is 28 days)</time_frame>
      <description>Defined as time to maximum plasma concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics (AUC0-t) for SY-3505</measure>
      <time_frame>Protocol-defined time points during Cycle 1 and 2 of treatment (each cycle is 28 days)</time_frame>
      <description>Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics (t½) for SY-3505</measure>
      <time_frame>Protocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)</time_frame>
      <description>Defined as the apparent plasma terminal phase disposition half-life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Response Rate (ORR) as assessed by RECIST v1.1</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Preliminary anti-tumor activity of SY-3505 in patients with LTK-fusion advanced solid tumor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR) as assessed by RECIST v1.1</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Preliminary anti-tumor activity of SY-3505 in patients with LTK-fusion advanced solid tumor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DOR) as assessed by RECIST v1.1</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Preliminary anti-tumor activity of SY-3505 in patients with LTK-fusion advanced solid tumor</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">38</enrollment>
    <condition>Advanced Solid Tumor</condition>
    <arm_group>
      <arm_group_label>Dose-escalation and Dose-expansion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In dose-escalation phase, SY-3505 will be given orally in ascending doses (escalation cohort) until the DLT or RP2D is reached.&#xD;
  In dose-expansion phase, SY-3505 will be given at RP2D in 28-day cycle continuously.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SY-3505</intervention_name>
      <description>LTK tyrosine kinase inhibitor</description>
      <arm_group_label>Dose-escalation and Dose-expansion</arm_group_label>
      <other_name>CT-3505</other_name>
      <other_name>Ficonalkib</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients must meet all of the following criteria to be eligible for this study:&#xD;
  &#xD;
                 1. Age ≥ 18 years at the time of signing the Informed Consent Form (ICF).&#xD;
  &#xD;
                 2. Histologically or cytologically confirmed locally advanced (as assessed by the&#xD;
                    investigator, unresectable tumor or tumor recurrence following standard therapy&#xD;
                    with evidence of progression [PD] or intolerance to prior therapy) or metastatic&#xD;
                    solid tumor and failure of standard treatment with evidence of disease&#xD;
                    progression on imaging.&#xD;
  &#xD;
                 3. Agreement to provide a required tumor tissue sample (preferably fresh biopsy&#xD;
                    tissue or archived tumor tissue within 2 years prior to first dosing) that has&#xD;
                    been tested by the central laboratory and determined to be positive for LTK gene&#xD;
                    fusion.&#xD;
  &#xD;
                 4. At least one measurable extracranial lesion as defined by Response Evaluation&#xD;
                    Criteria in Solid Tumors (RECIST) v 1.1 criteria.&#xD;
  &#xD;
                 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.&#xD;
  &#xD;
                 6. Expected survival of ≥ 3 months.&#xD;
  &#xD;
                 7. Resolution of any treatment-related AEs related to prior anticancer therapy to&#xD;
                    NCI-CTCAE v 5.0 grade ≤ 1 (excluding toxicities judged by the investigator to be&#xD;
                    of no safety concern, e.g., hair loss, prior platinum-related grade 2 peripheral&#xD;
                    neuropathy) before the first dosing.&#xD;
  &#xD;
                 8. Organ function levels must meet the following requirements:&#xD;
  &#xD;
                      1. No blood products, hematopoietic growth factors (e.g., G-CSF,&#xD;
                         erythropoietin), or other drugs that correct abnormal blood counts for at&#xD;
                         least 2 weeks before first dosing and the following blood counts: ANC ≥ 1.5&#xD;
                         × 10^9/L, PLT count ≥ 100 × 10^9/L, Hb ≥ 90 g/L.&#xD;
  &#xD;
                      2. Liver function: TBIL ≤ 1.5 × upper limit of normal (ULN) in the absence of&#xD;
                         liver metastases, and AST and ALT ≤ 2.5 × ULN; in the presence of liver&#xD;
                         metastases, AST and ALT ≤ 5.0 × ULN, and TBIL ≤ 3 × ULN.&#xD;
  &#xD;
                      3. Pancreatic function: Serum total amylase ≤ 1.5 × ULN and serum lipase ≤ 1.5&#xD;
                         × ULN (subjects with serum total amylase &gt; 1.5 × ULN but with serum lipase&#xD;
                         within the ULN range may be eligible).&#xD;
  &#xD;
                      4. Renal function: Creatinine clearance (Ccr) ≥ 50 mL/min (calculated using the&#xD;
                         Cockcroft and Gault formula).&#xD;
  &#xD;
                      5. Coagulation function: International normalized ratio (INR) and prothrombin&#xD;
                         time (PT) ≤ 2 × ULN (except for patients receiving anticoagulant therapy).&#xD;
  &#xD;
                 9. Able to take oral medications and comply with scheduled visits and related&#xD;
                    procedures per protocol.&#xD;
  &#xD;
                10. Female subjects of childbearing potential must agree to use highly effective&#xD;
                    contraception during the entire study period and for at least 3 months after the&#xD;
                    last dose&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who meet any of the following criteria are not eligible for this study:&#xD;
  &#xD;
                 1. Carrying known major driver gene mutations other than LTK gene, such as EGFR,&#xD;
                    MET, ALK, ROS1, NTRK, etc. (Patients with co-mutations may be discussed with the&#xD;
                    investigator for eligibility).&#xD;
  &#xD;
                 2. History of hypersensitivity reactions to any component or excipient of SY-3505&#xD;
                    capsules.&#xD;
  &#xD;
                 3. Concurrent primary malignancy, with the following exceptions: adequately treated&#xD;
                    in situ carcinoma, non-melanoma skin cancer, in situ cervical cancer, or in situ&#xD;
                    breast cancer, and cured malignancies without recurrence for at least 2 years&#xD;
                    prior to study entry.&#xD;
  &#xD;
                 4. Symptomatic primary central nervous system (CNS) tumors, symptomatic CNS&#xD;
                    metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.&#xD;
                    Patients with stable CNS disease (defined as no evidence of progression on&#xD;
                    imaging for at least 4 weeks prior to first dosing, with all neurological&#xD;
                    symptoms returned to baseline, and without evidence of new or enlarging brain&#xD;
                    metastases, and no CNS surgery or radiation treatment within 4 weeks prior to&#xD;
                    first dosing, and no stereotactic radiosurgery [SRS] within 2 weeks prior to&#xD;
                    first dosing, and no steroids for at least 2 weeks) are eligible. (Note:&#xD;
                    Carcinomatous meningitis is not allowed, regardless of clinical stability).&#xD;
  &#xD;
                 5. Presence of any of the following conditions or diseases at screening that are&#xD;
                    inadequately controlled with the best possible medical management:&#xD;
  &#xD;
                      1. Active systemic bacterial, viral, or fungal infections.&#xD;
  &#xD;
                      2. Pleural effusion, peritoneal effusion, or pericardial effusion that is not&#xD;
                         controlled after intervention (defined as significant if reaccumulation of&#xD;
                         fluid requiring drainage occurs within 2 weeks of the prior intervention&#xD;
                         with associated symptoms).&#xD;
  &#xD;
                      3. Poorly controlled diabetes mellitus (defined as fasting blood glucose ≥ 11.1&#xD;
                         mmol/L and/or HbA1c ≥ 8%).&#xD;
  &#xD;
                      4. Symptomatic hyperthyroidism or hypothyroidism not well controlled by medical&#xD;
                         management as assessed by the investigator.&#xD;
  &#xD;
                      5. Clinically significant electrolyte disturbances (e.g., severe hypocalcemia,&#xD;
                         hypomagnesemia, hypokalemia) as assessed by the investigator.&#xD;
  &#xD;
                      6. Clinically significant gastrointestinal diseases that may interfere with the&#xD;
                         absorption of study drug (e.g., active ulcerative colitis, Crohn's disease,&#xD;
                         gastrointestinal ulcers, or major gastrointestinal surgery that might affect&#xD;
                         drug absorption).&#xD;
  &#xD;
                 6. Severe cardiovascular diseases/abnormalities meeting any of the following&#xD;
                    criteria:&#xD;
  &#xD;
                      1. QT interval corrected for heart rate (QTcF) &gt; 470 msec for females or &gt; 450&#xD;
                         msec for males as calculated by the Fridericia formula during screening&#xD;
                         (subjects with suspected drug-induced QTcF prolongation that is assessed by&#xD;
                         the investigator as safely controllable may be eligible after correction&#xD;
                         with medication).&#xD;
  &#xD;
                      2. Left ventricular ejection fraction (LVEF) &lt; 50%.&#xD;
  &#xD;
                      3. Myocardial infarction, unstable angina, or clinically significant&#xD;
                         arrhythmias (e.g., grade 2 second-degree heart block or third-degree heart&#xD;
                         block) within 6 months prior to the first dosing.&#xD;
  &#xD;
                      4. Class III or IV congestive heart failure as classified by the New York Heart&#xD;
                         Association (NYHA).&#xD;
  &#xD;
                      5. Poorly controlled hypertension, a history of unstable hypertension, or a&#xD;
                         history of poor compliance with antihypertensive treatment as assessed by&#xD;
                         the investigator.&#xD;
  &#xD;
                 7. Active viral infections or a history of the following:&#xD;
  &#xD;
                      1. Active hepatitis B (HBV) infection (defined as HBsAg positive and HBV DNA ≥&#xD;
                         2 × 10^3 IU/mL at screening, unless HBV DNA levels have decreased to &lt; 2 ×&#xD;
                         10^3 IU/mL after regular antiviral therapy, in which case the patient may be&#xD;
                         eligible), or active hepatitis C (HCV) infection (HCV RNA &gt; central&#xD;
                         laboratory ULN) at screening.&#xD;
  &#xD;
                      2. HIV positivity at screening or known other immunodeficiency disease.&#xD;
  &#xD;
                      3. Previous organ transplantation, hematopoietic stem cell transplantation, or&#xD;
                         bone marrow transplantation.&#xD;
  &#xD;
                 8. Other significant systemic diseases, including but not limited to active&#xD;
                    pulmonary disease (e.g., active tuberculosis, interstitial lung disease), that,&#xD;
                    in the investigator's judgment, may affect the interpretation of study results or&#xD;
                    pose high risks to the patient.&#xD;
  &#xD;
                 9. Use of strong CYP3A4 inhibitors or inducers within 2 weeks before the first&#xD;
                    dosing or during the study period, as follows:&#xD;
  &#xD;
                      1. CYP3A4 Inhibitors: Azanavir, Clarithromycin, Erdafitinib, Itraconazole,&#xD;
                         Ketoconazole, Nafitamone, Letermovir, Saquinavir, Telithromycin,&#xD;
                         Vinorelbine, Grapefruit (juice).&#xD;
  &#xD;
                      2. CYP3A4 Inducers: Carbamazepine, Phenobarbital, Phenytoin, Rifabutin,&#xD;
                         Rifampicin, St. John's Wort, Rifapentine.&#xD;
  &#xD;
                10. Receipt of any of the following anticancer treatments:&#xD;
  &#xD;
                      1. Bone marrow radiation or extensive radiotherapy involving more than 30% of&#xD;
                         the bone marrow: within 4 weeks before first dosing.&#xD;
  &#xD;
                      2. Palliative radiotherapy: within 7 days before first dosing.&#xD;
  &#xD;
                      3. Other anticancer treatments such as chemotherapy, targeted therapy&#xD;
                         (immunotherapy or other antibody therapy), antitumor Chinese medicine, or&#xD;
                         others: within 2 weeks before first dosing or within 5 half-lives of the&#xD;
                         treatment (whichever is longer).&#xD;
  &#xD;
                11. Major surgery within 4 weeks before first dosing (major surgery defined as a&#xD;
                    surgery grade ≥ 3, excluding placement of a central venous catheter, tumor&#xD;
                    puncture biopsy, and gastrostomy tube placement) or significant traumatic injury&#xD;
                    that has not fully recovered.&#xD;
  &#xD;
                12. Participation in other clinical studies within 4 weeks before first dosing&#xD;
                    (except for those that do not use investigational drugs or investigational&#xD;
                    medical devices; subjects who have discontinued treatment from other clinical&#xD;
                    studies and are only undergoing follow-up are excluded).&#xD;
  &#xD;
                13. Severe thromboembolic events within 1 year before the first dosing (e.g.,&#xD;
                    cerebrovascular accidents [including transient ischemic attacks], deep vein&#xD;
                    thrombosis, pulmonary embolism) or a bleeding tendency/risks within 30 days&#xD;
                    before the first dosing (e.g., significant gastrointestinal bleeding).&#xD;
  &#xD;
                14. Pregnant or lactating women.&#xD;
  &#xD;
                15. Other circumstances, as determined by the investigator, which make the patient&#xD;
                    unsuitable for participation in this clinical trial, such as other serious acute&#xD;
                    or chronic diseases that may increase the patient's related risks in the study or&#xD;
                    laboratory abnormalities that may interfere with the interpretation of study&#xD;
                    results.&#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>Yinghui Sun, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Shouyao Holdings (Beijing) Co. LTD</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yinghui Sun, PhD</last_name>
      <phone>86-10-88858616</phone>
      <email>yhsun@centaurusbio.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cancer Hospital, Chinese Academy of Medical Sciences</name>
        <address>
          <city>Beijing</city>
          <zip>100021</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yuankai Shi, MD</last_name>
        <phone>86-10-87788293</phone>
        <email>syuankai@cicams.ac.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>SY-3505</keyword>
    <keyword>Leukocyte receptor tyrosine kinase fusion-positive</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>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/NCT06037317
  org study id: CT-3505-I-03
  nct id: NCT06037317
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is an open-label, single-arm, multicenter, phase Ib study to evaluate the efficacy and
        safety of SY-3505 capsule in patients with locally advanced or metastatic, LTK
        fusion-positive solid tumor who have progressed on or are intolerant to prior standard
        therapy.
  The study will be conducted in 2 parts:
  
        Dose-escalation phase: Participants will be allocated to one of the three dose groups of
        500mg, 600mg, or 800mg and receive a single dose of SY-3505 capsules, followed by a 7-day
        safety observation period and pharmacokinetic (PK) assessment. Subsequently, SY-3505 will be
        administered once daily in 28-day treatment cycles. This phase is designed to determine the
        DLTs (Dose-limiting toxicity) and recommended phase II dose (RP2D) and characterize the
        safety, tolerability and PK of SY-3505 in patients with LTK fusion-positive solid tumors.
  
        Dose-expansion phase: Participants will be assigned to one of the 1-2 dose groups determined
        during the dose-escalation phase, and receive SY-3505 capsules once daily in 28-day treatment
        cycles. This phase is designed to evaluate the anti-tumor activity (ORR, DCR and DOR) of
        SY-3505 in patients with LTK fusion-positive solid tumors.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of adverse events (AEs)
  time frame: Up to 2 years
  description: Characterization of the safety and tolerability
  measure: Incidence of dose limiting toxicities (DLTs)
  time frame: Escalation Cycle 1 (28 days)
  description: Maximum Tolerated Dose (MTD) and/or recommended phase 2 dose (RP2D) in Cycle 1
  measure: Pharmacokinetics (Cmax) for SY-3505
  time frame: Protocol-defined time points during Cycle 1 and 2 of treatment (each cycle is 28 days)
  description: Defined as maximum observed plasma concentration
  measure: Pharmacokinetics (Tmax) for SY-3505
  time frame: Protocol-defined time points during Cycle 1 and 2 of treatment (each cycle is 28 days)
  description: Defined as time to maximum plasma concentration
  measure: Pharmacokinetics (AUC0-t) for SY-3505
  time frame: Protocol-defined time points during Cycle 1 and 2 of treatment (each cycle is 28 days)
  description: Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration
  measure: Pharmacokinetics (t½) for SY-3505
  time frame: Protocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)
  description: Defined as the apparent plasma terminal phase disposition half-life
  measure: Overall Response Rate (ORR) as assessed by RECIST v1.1
  time frame: Up to 2 years
  description: Preliminary anti-tumor activity of SY-3505 in patients with LTK-fusion advanced solid tumor
  measure: Disease control rate (DCR) as assessed by RECIST v1.1
  time frame: Up to 2 years
  description: Preliminary anti-tumor activity of SY-3505 in patients with LTK-fusion advanced solid tumor
  measure: Duration of response (DOR) as assessed by RECIST v1.1
  time frame: Up to 2 years
  description: Preliminary anti-tumor activity of SY-3505 in patients with LTK-fusion advanced solid tumor
  arm group label: Dose-escalation and Dose-expansion
  arm group type: Experimental
  description: In dose-escalation phase, SY-3505 will be given orally in ascending doses (escalation cohort) until the DLT or RP2D is reached.
  In dose-expansion phase, SY-3505 will be given at RP2D in 28-day cycle continuously.
  intervention type: Drug
  intervention name: SY-3505
  description: LTK tyrosine kinase inhibitor
  arm group label: Dose-escalation and Dose-expansion
  other name: CT-3505
  other name: Ficonalkib
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yinghui Sun, PhD
  role: Study Director
  affiliation: Shouyao Holdings (Beijing) Co. LTD
  last name: Yinghui Sun, PhD
  phone: 86-10-88858616
  email: yhsun@centaurusbio.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms