[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cullgen (Shanghai),Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100623264","phase-1-a-phase-12-study-of-cg001419-tablets-in-adult-subjects-with-locally-advanced-or-metastatic-solid-tumours-harbouring-ntrk-gene-abnormalities-100623264",false,"NCT07394374","A Phase 1\u002F2 Study of CG001419 Tablets in Adult Subjects With Locally Advanced or Metastatic Solid Tumours Harbouring NTRK Gene Abnormalities","A Phase 1\u002F2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CG001419 Tablets in Adult Patients With Locally Advanced\u002FMetastatic Solid Tumors Harboring NTRK Gene Fusions, Mutations, or Amplification\u002FOver Expression.","1. Age ≥18 when signing the informed consent form, regardless of gender.\n2. The estimated survival time is ≥3 months.\n3. Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors that have failed, are intolerant to, or have no available standard therapy.\n4. Dose Escalation Phase: While testing for NTRK\u002FTRK status is not mandatory, enrollment priority will be accorded to patients whose tumors harbor oncogenic NTRK\u002FTRK alterations. Dose Expansion and Indication Expansion Phases: Enrollment eligibility is contingent upon the confirmation of oncogenic NTRK\u002FTRK alterations, as ascertained through tumor tissue or peripheral blood testing.\n5. The Indication Expansion Phase will enroll subjects into the following three cohorts, with respective entry criteria:\n\n   Cohort 1: Subjects with a confirmed oncogenic NTRK fusion who have not received prior treatment with entrectinib, larotrectinib, and\u002For other selective TRK-TKIs.\n\n   Cohort 2: Subjects with a confirmed oncogenic NTRK fusion who have experienced treatment failure with entrectinib, larotrectinib, and\u002For other selective TRK-TKIs.\n\n   Cohort 3: Subjects with confirmed non-fusion NTRK alterations, including point mutations, gene amplification, or TRK protein overexpression, and a positive pan-TRK immunohistochemistry (IHC) result, regardless of prior TRK-TKI treatment.\n\n   Notes:1)NTRK point mutations include Single Nucleotide Variants (SNVs) and Insertion-Deletions (InDels). 2)Positive pan-TRK IHC is defined as \\>1% of tumor cells staining stronger than the background (with an intensity ≥1+).3) NTRK gene amplification is defined as a DNA copy number ≥4 and a positive pan-TRK IHC result.TRK protein overexpression is defined as ≥2+ pan-TRK IHC staining in \\>5% of tumor cells.4) Over-expression of TRK protein is defined as \\> 5% tumor cells with pan-TRK protein immunohistochemical staining ≥2+.\n6. Must have at least one measurable target lesion according to RECIST v1.1. (For patients with HCC, mRECIST v1.1 should be used; for patients with primary CNS tumors or brain metastases, RANO criteria may be used.). During the Dose-Finding Phase, evaluable but non-measurable lesions are acceptable.\n7. Subjects with primary CNS tumors or brain metastases must be clinically stable for at least 2 weeks after prior treatment, with no requirement for corticosteroids, or be on a stable or decreasing dose of ≤4 mg\u002Fday of dexamethasone (or equivalent) for at least 4 weeks. Concomitant administration of prophylactic, non-hepatic enzyme-inducing antiepileptic drugs is permitted.\n8. The physical fitness status (PS) score of the American Eastern Cancer Cooperative Group (ECOG) is ≤ 2.\n9. The subject agrees to provide either the results of genetic testing from a tumor tissue specimen obtained within 1 year after the completion of the prior therapy from a laboratory capable of ensuring quality results, or a tumor tissue specimen (archival or fresh biopsy) and\u002For peripheral blood for NTRK status confirmation, and is willing to consider undergoing a tumor biopsy and\u002For providing peripheral blood during the study for the assessment of changes in tumor molecular status, if deemed safe and feasible by the Investigator.\n10. Adequate organ function must be confirmed by laboratory test results within 7 days prior to the first dose of study drug, meeting all the following criteria:\n\n1)Absolute Neutrophil Count (ANC) ≥1.5×10⁹\u002FL, platelet count ≥90×10⁹\u002FL, and hemoglobin ≥90 g\u002FL, with no transfusion or colony-stimulating factor therapy administered within 14 days prior to the test; 2)Liver function: albumin ≥28 g\u002FL, total bilirubin (TBIL) ≤1.5 × ULN, AST (or SGOT), ALT (or SGPT), and alkaline phosphatase (ALP) ≤2.5 × ULN; for subjects with known Gilbert's syndrome, TBIL ≤3 × ULN and direct bilirubin ≤1.5 × ULN; in the presence of liver metastases: ALT and AST ≤5 × ULN; in the presence of bone metastases: ALP ≤5 × ULN; 3)Renal function: serum creatinine (Cr) ≤1.5 × ULN or calculated creatinine clearance \\>50 mL\u002Fmin (creatinine clearance should be calculated using the Cockcroft-Gault formula).\n\n11\\. All toxicities from prior anticancer therapy must have recovered to ≤ Grade 1 according to the NCI-CTCAE version 5.0, with the exception of alopecia and stable chronic conditions.\n\n12\\. Be able to swallow tablets (the tablets should be as complete as possible, and can be ground if necessary, but not excessively ground).\n\n13\\. Not pregnant or lactating.\n\n* Female subjects of childbearing potential (as defined in Appendix 3) must have a negative serum pregnancy test (for beta-human chorionic gonadotropin \\[β-hCG\\]) at screening.\n* A female subject is considered NOT to be of childbearing potential if she meets at least one of the following criteria: natural amenorrhea for ≥ 12 consecutive months with corresponding clinical characteristics (e.g., age, history of vasomotor symptoms); or has undergone bilateral oophorectomy, or hysterectomy. However, subjects with bilateral tubal ligation must undergo a serum pregnancy test.\n* Male subjects with female partners of childbearing potential and female subjects of childbearing potential must agree to use highly effective contraception or practice abstinence during the treatment period and for 90 days after the last dose of CG001419 tablets (detailed contraceptive guidance refers to Appendix 3). Male subjects must also refrain from donating sperm during the study period and for 90 days after the last dose of CG001419 tablets.\n\n  14\\. The subject voluntarily participates in this study and signs the informed consent form (ICF), demonstrating understanding of the study's purpose, procedures, nature, significance, potential benefits, and risks, and is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study instructions or procedures.","ALL","18 Years",{"count":19,"type":20},42,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to learn about the safety of drug CG001419. It also learn if drug CG001419 works to treat in locally advanced\u002Fmetastatic adult solid tumours with NTRK gene fusions, NTRK gene point mutations, and NTRK gene amplification or over expression.\n\nThe main questions it aims to answer are:\n\nPhase1:To determind the Maximum Tolerated Dose (MTD) and\u002For Phase 2 Recommended Dose for Phase 2 (RP2D) of CG001419 administered orally to adult subjects with locally advanced\u002Fmetastatic solid tumours. To establish the safety and tolerability profile of CG001419.\n\nPhase2:To evaluate the efficacy of CG001419 in adult subjects with locally advanced or metastatic solid tumours harbouring oncogenic NTRK fusions, mutations, amplifications or over expression.\n\nParticipants will Receive treatment with CG001419 until disease progression.",[27,28,29,30],"Solid Tumors Harboring NTRK Fusion","NTRK","NTRK Gene Fusion","NTRK Fusion Positive",[32,33],"NRTK","CG001419","RECRUITING","2026-02-03",{"date":37,"type":38},"2026-02-06","ACTUAL",{"date":40,"type":38},"2023-06-20",{"date":42,"type":20},"2030-08-30",{"name":44,"class":45},"Cullgen (Shanghai),Inc","OTHER",6,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100619634","phase-1-a-phase-1-study-of-cg009301-for-injection-in-adult-subjects-with-recurrent-or-refractory-haematological-malignancies-100619634","NCT07347171","A Phase 1 Study of CG009301 for Injection in Adult Subjects With Recurrent or Refractory Haematological Malignancies","A Phase 1, Open-label, Multicentre Study Evaluating the Safety, Tolerability, Pharmacokinetic\u002FPharmacodynamic Characteristics, and Preliminary Efficacy of CG009301 for Injection in Adult Subjects With Relapsed or Refractory Haematological Malignancies","Inclusion Criteria:\n\n1. Age ≥18 years and \\\u003C75 years at the time of signing the informed consent form; no gender restrictions;\n2. Patients with relapsed\u002Frefractory haematological malignancies who have received a definitive diagnosis by pathology and\u002For cytology, confirmed histologically, and who have failed prior standard treatment regimens. The investigator must deem that no standard treatment is available or that the patient cannot tolerate existing therapies. Dose-escalation phase: unrestricted haematological tumour types. Dose-expansion phase: must meet one of the following criteria: a. Subjects meeting AML diagnostic criteria based on WHO 2022 5th edition classification, confirmed by bone marrow cytomorphology, including AML evolving from early-stage MDS or MPN. Criteria for recurrent AML: Leukaemic cells reappearing in peripheral blood after CR, or \\>5% blast\u002Fimmature cells in bone marrow, or extramedullary leukaemic infiltration. Criteria for refractory AML: - Treatment-naïve cases unresponsive to two standard-regimen cycles; - Relapse within 12 months after consolidation\u002Fintensification therapy following CR; - Relapse after 12 months unresponsive to conventional chemotherapy; Patients with two or more relapses; Persistent extramedullary leukaemia; b. Patients diagnosed with high-risk or very high-risk MDS according to the WHO 2022 5th edition classification, with a percentage of blasts in bone marrow smear or biopsy pathology \\\u003C 20%, and deemed by the investigator to have no other appropriate treatment options. Diagnostic criteria for recurrent MDS: Following achievement of complete remission, partial remission, or haematological improvement, at least one of the following must occur: - Bone marrow blastic count returns to pre-treatment levels; - ANC or PLT decreases by ≥50% from best response; - HGB decreases by ≥15 g\u002FL or becomes transfusion-dependent. Diagnostic criteria for refractory MDS: Following adequate treatment (at least four cycles of demethylating agent therapy), meeting the IWG 2023 response criteria for \"stable disease\", \"failure\", or \"disease progression\"; progression after demethylating agent or other drug therapy, or patient intolerance to toxicity (e.g., treatment-related grade 3 or higher hepatic or renal toxicity during therapy leading to permanent discontinuation); c. Subjects meeting ALL diagnostic criteria based on WHO 2022 5th edition classification, with ≥20% primitive\u002Fimmature lymphocytes in bone marrow. Relapsed ALL diagnostic criteria: Patients who, after achieving CR following induction therapy, exhibit recurrence of leukaemic cells in peripheral blood, \\>5% primitive\u002Fimmature lymphocytes in bone marrow, or development of extramedullary disease; Criteria for refractory ALL: Patients failing to achieve CR following standard induction therapy;\n3. ECOG performance status score of 0-1;\n4. Investigator-assessed expected survival ≥3 months;\n5. Recovery of toxicities from prior treatment to ≤Grade 1 according to NCI-CTCAE v5.0 (excluding alopecia and long-term stable chronic conditions);\n6. No prior autologous haematopoietic stem cell transplantation, or transplantation more than 2 months prior with toxicities resolved to ≤ Grade 1;\n7. Adequate organ function support, with screening laboratory tests meeting all criteria: a. Coagulation function prior to study drug administration: INR ≤ 1.5 × ULN or aPTT ≤ 1.5 × ULN; b. Hepatic function: serum total bilirubin ≤ 2× ULN; AST and\u002For ALT ≤ 2.5× ULN; c. Cr ≤ 2× ULN or CrCL \\> 30 mL\u002Fmin (calculated using Cockcroft-Gault formula); d. LVEF ≥ 40%; and QTc ≤ 480 milliseconds; e. White blood cell count may decrease below 50.0 × 10⁹\u002FL at baseline or following hydroxyurea administration\n8. Non-pregnant and non-lactating: Infertile subjects; or subjects with potential for conception who agree to use effective contraception (hormonal, barrier, or abstinence). Male subjects must also abstain from sperm donation during study participation and for 90 days after the last dose of CG009301 injection. Women of childbearing potential must have a negative serum pregnancy test (serum-β-hCG) during the screening period;\n9. Understand the study's purpose, process, nature, significance, potential benefits, and risks, and voluntarily sign the written informed consent form. Be able to comply with scheduled visits, treatment plans, laboratory tests, and other study instructions or procedures.\n\nExclusion Criteria:\n\n1. Central nervous system leukaemia presenting with neurological and\u002For psychiatric symptoms;\n2. Receipt of antitumour therapy (excluding hydroxyurea and prophylactic intrathecal injections) such as chemotherapy, immunotherapy, targeted therapy, or biological therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first study drug administration; receipt of radiotherapy within 2 weeks; receipt of traditional Chinese herbal medicine within 2 weeks;\n3. Major surgery within 4 weeks prior to the first study dose, or anticipated need for major surgery during the study period;\n4. Active infection deemed uncontrolled by the investigator following treatment with antibiotics, antiviral agents, or antifungal medications;\n5. Severe or uncontrolled underlying medical conditions deemed ineligible for inclusion by the investigator, including but not limited to respiratory disorders (e.g., chronic obstructive pulmonary disease requiring oxygen therapy, moderate or higher asthma, moderate or higher pulmonary fibrosis, recurrent pulmonary oedema), cardiovascular disorders (e.g., prior coronary artery bypass grafting or coronary stent implantation, myocardial infarction within the past 6 months, NYHA Class III-IV heart failure), unstable angina within the past 6 months, uncontrolled hypertension (systolic \\>160 mmHg or diastolic \\>100 mmHg), arrhythmias requiring ongoing medical or interventional management), endocrine disorders (severe hyperthyroidism\u002Fhypothyroidism, uncontrolled diabetes mellitus), and neurological\u002Fpsychiatric conditions affecting cognition, compliance, or personal safety (e.g., unstable epilepsy, dementia, schizophrenia, depression); psychiatric disorders (e.g., unstable epilepsy, dementia, schizophrenia, depression);\n6. Active autoimmune diseases (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis, rheumatoid arthritis), or allergy to the study drug or excipients;\n7. Significant non-leukaemia-related bleeding risk (e.g., anticoagulant or antiplatelet therapy, arteriovenous malformation), or recent history of major bleeding (e.g., gastrointestinal haemorrhage, intracranial haemorrhage, disseminated intravascular coagulation);\n8. Grade 2 or higher central nervous system or peripheral neuropathy (excluding stable Grade 3 conditions lasting over 6 months that do not impair daily functioning);\n9. Allogeneic haematopoietic stem cell transplantation within 12 months prior to initial administration;\n10. History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolic event within 6 months prior to initial administration (thrombosis originating from implanted venous access ports or catheters, superficial vein thrombosis, or lacunar cerebral infarction are not considered \"severe\" thromboembolic events); Known familial and\u002For acquired thrombotic predisposition, such as hereditary or acquired defects in anticoagulant proteins, coagulation factors, fibrinolytic proteins, or presence of acquired risk factors conferring high thrombotic propensity;\n11. HIV, HBV, and HCV infection: positive HIV antibody and PCR tests; HBsAg positive or viral DNA ≥100 IU\u002FmL; positive HCV antibody with HCV-RNA quantification exceeding the upper limit of normal;\n12. Individuals who received (attenuated) live virus vaccination within 4 weeks prior to first dosing;\n13. Individuals with a documented history of alcohol or substance abuse;\n14. Any past or current medical condition, treatment, or laboratory abnormality that may interfere with study results or affect the subject's ability to complete the study, or if the investigator deems the subject unsuitable for participation in this study.","75 Years",{"count":56,"type":20},45,[23],"The goal of this clinical trial is to learn about the safety of drug CG009301. It also learns if drug CG009301 works to treat in Participants with relapsed or refractory adult haematological malignancies.\n\nThe main question\\[s\\] it aims to answer are:\n\n1. To determine the maximum tolerated dose (MTD) and\u002For objective best dose (OBD) of CG009301 for injection in subjects with relapsed or refractory adult haematological malignancies.\n2. To establish subsequent dosing regimens for CG009301 for injection.\n3. To characterise the safety profile and tolerability of CG009301 for injection. Participants will Receive treatment with CG009301 until disease progression.",[60,61,62,63,64],"Leukemia","AML","MDS","AML (Acute Myelogenous Leukemia)","MDS (Myelodysplastic Syndrome)",[60,66,67,61,62],"GSPT1","CG009301","2026-01-08",{"date":70,"type":38},"2026-01-16",{"date":72,"type":38},"2025-04-17",{"date":74,"type":20},"2027-12-30",{"name":44,"class":45},3,""]