[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing Scitech-Mq Pharmaceuticals Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100543745","phase-1-a-study-of-st-1898-for-unresectable-or-metastatic-melanoma-100543745",false,"NCT06359860","A Study of ST-1898 for Unresectable or Metastatic Melanoma","A Phase Ib\u002FII Study to Evaluate the Efficacy and Safety of ST-1898 in Subjects With Unresectable or Metastatic Melanoma","Inclusion Criteria:\n\n1. Age \\>= 18 years\n2. Life expectancy of three months or more\n3. Histologically or cytologically confirmed unresectable or metastatic stage III or IV acral melanoma that was progressed with conventional therapy\n4. Recommendation of subject offering archived tissue sample or previous biomarker test report. If archived tumor sample is not available, a fresh biopsy is optional, which need to be taken from needle biopsy or core needle biopsy (fine needle biopsy not allowed)\n5. Eastern Cooperative Oncology Group performance status (PS) ≤ 1\n6. At least one measurable lesion per RECIST 1.1\n7. Has adequate organ function defined as follows:\n\n   * Absolute neutrophil count ≥ 1.5 ×10\\^9\u002FL, Platelets ≥ 75× 10\\^9\u002FL and Hemoglobin ≥ 90 g\u002FL (no blood transfusions, no platelet transfusions and no use of colony stimulating factor within 2 weeks prior to routine blood test) at screening;\n   * Serum creatinine ≤1.5 × upper limit of normal (ULN)\n   * Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 2.5 ULN, AST\u002FALT ≤ 5 ULN for liver metastasis;\n   * Total bilirubin ≤ 1.5 ULN\n   * International normalized ratio (INR) ≤ 1.5 ULN, or prothrombin time (PT) ≤1.5 ULN\n   * Activated partial thromboplastin time (APTT) ≤1.5 ULN\n   * Serum albumin ≥30 g\u002FL\n8. Willing and able to provide written Informed consent.\n9. Eligible male and female subjects with fertility activity or their sexual partners must use effective contraception during study period and though 90 days after last study treatment. Women of child-bearing age must have a negative serum pregnancy test within 7 days before first study treatment\n\nExclusion Criteria\n\n1. Subjects with one of the following conditions prior to first dose, including, but not limiting to：\n\n   * A history of antitumor therapy within 4 weeks, including chemotherapy, radiotherapy, biotherapy, endocrine therapy or immunotherapy, etc.;\n   * A history of oral fluoropyrimidines and small molecular targeted-drug therapy within 2 weeks or 5 half-life time （the longer time taken as final）;\n   * A history of traditional Chinese medicine with antitumor indication within 2 weeks;\n2. A history of being participant in clinical trial of other unapproved drugs within 4 weeks;\n3. A major operation or severe trauma within 4 weeks, （except tumor biopsy, puncture,）invasive dental procedures such as dental extraction, dental implants etc.\n4. Current or previous severe retinopathy who, in the judgment of the Investigator, are not suitable for enrollment\n5. A history of clinically significant cardiovascular or cerebrovascular disease, including, but not limiting to:\n\n   * Severe arrhythmia or heart conduction disturbance, such as second-degree or third-degree atrio-ventricular block or ventricular arrhythmia indicated with medical intervention\n   * QTc (by Fridericia): male \\>450 ms, female \\>470 ms\n   * Major cardiovascular events within 6 months prior to first dose, including acute coronary syndrome, stroke, deep vein thrombosis, pulmonary-thromboembolism and other ≥Grade 3 arterial-thrombosis events, or congestive heart failure, or aortic dissection etc.；\n   * New York Heart Association Class ≥ II；\n   * Left ventricular ejection fraction（LVEF）\\\u003C50%；\n   * Uncontrolled hypertension (blood pressure≥140\u002F90 mmHg even with antihypertensive therapy)\n6. Subjects with active leptomeningeal disease or brain metastases without being well controlled, except subjects with asymptomatic or treated brain metastases being stable imaging between 12 weeks before screening；\n7. Subjects with interstitial lung disease or radiation pneumonia in needs of corticosteroids therapy\n8. Subjects with clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 7 days prior to first dose;\n9. Subjects with malignant tumors in the last 5 years (not including non-melanoma skin cancer, breast cancer or cervical cancer in situ, and superficial bladder transient cell carcinoma that have been cured)\n10. A history of ≥ grade 3 bleeding episodes within 6 months prior to first dose; or currently ≥ grade 2 hemorrhage, with angioneoplasm\u002F vascular malformation, with high bleeding risks (such as active peptic ulcer or esophageal varices)\n11. Within 2 weeks prior to first dose of concomitant medication with strong inducers of CYP3A4, strong inhibitors of CYP3A4, or substrates with narrow therapeutic windows of CYP3A4;\n12. Subjects with ≥ Grade 2 (by CTCAE) toxicities caused by previous therapy (not including ≤Grade 2 peripheral neuropathy, alopecia, or other tolerated and no possible safety hazard events as determined by the investigator);\n13. Subjects with active hepatitis B, unless HBV-DNA titer in the normal range (for subjects with positive HBsAg but HBV-DNA titer eligible, prophylactic antiviral therapy except interferon is allowed); active hepatitis C (ANTI-HCV positive)；\n14. Subjects with positive HIV antibodies or Treponema pallidum antibodies;\n15. Subjects with acute bacterial, viral or fungal infections, and in needs of systemic antimicrobial therapy;\n16. Pregnant or lactating females;\n17. Subjects with significant neuropsychiatric disorders, leading to poor compliance;\n18. Subjects with underlying diseases (including abnormal laboratory investigations), alcohol, drug abuse, or drug dependence, all which affect the interpretation of toxicities or adverse event, or decrease;\n19. Subjects with oral administration impossible, or in the conditions of malabsorption as determined by the investigator, such as dysphagia and intestinal obstruction, etc.;\n20. Subjects with significant liver cirrhosis, hepatatrophy, portal hypertension, or more than moderate volume of ascites;\n21. A history of organ transplant;\n22. A history of other severe systemic disease, or not suitable as determined by the investigator due to any other reasons;\n23. A history of inoculation with live vaccine within 28 days prior to first dose. Note: Seasonal influenza vaccine is a broadly inactivated vaccine and is permitted. Inactivated COVID-19 vaccines are permitted. COVID-19 mRNA vaccines are not allowed. Intranasal influenza vaccines are live vaccines and are not allowed.","ALL","18 Years",{"count":19,"type":20},64,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","ST-1898 is a receptor tyrosine kinase (RTK) inhibitor for multi-targets, especially for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT etc. This trial is to evaluate its safety, tolerability, pharmacokinetic, and efficacy in subjects with unresectable or metastatic melanoma.\n\nIn phase Ib, the primary objectives are to assess the safety and tolerability, and to determine Recommended Phase 2 dose (RP2D) of ST-1898 tablets in subjects with unresectable or metastatic melanoma. Secondary objectives are to assess the plasma concentration of ST-1898 and to evaluate the efficacy.\n\nIn phase II, the primary objective is to assess the anti-tumor activities of ST-1898 tablets in subjects with unresectable or metastatic melanoma. The secondary objective is to evaluate the safety of ST-1898 tablets.",[27],"Unresectable or Metastatic Melanoma",[29,30],"ST-1898","Melanoma","RECRUITING","2025-08-22",{"date":34,"type":35},"2025-08-24","ACTUAL",{"date":37,"type":35},"2023-11-07",{"date":39,"type":20},"2026-12",{"name":41,"class":42},"Beijing Scitech-Mq Pharmaceuticals Limited","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":43},"100543744","phase-2-study-of-st-1898-in-locally-advanced-or-metastatic-radioiodine-refractory-differentiated-thyroid-cancer-100543744","NCT06359847","Study of ST-1898 in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Cancer","A Multicenter, Phase II Clinical Trial to Evaluate the Efficacy and Safety of ST-1898 Tablets in Patients With Locally Advanced or Metastatic RAIR-DTC After Failure of at Least First-line TKI Systemic Therapy","Eligibility Minimum Age: 18 Years\n\nMaximum Age:\n\nSex: All\n\nGender Based:\n\nAccepts Healthy Volunteers: No\n\nCriteria: Inclusion Criteria:\n\n1. Age \\>= 18 years\n2. Life expectancy of twelve weeks or more\n3. Histologically or cytologically confirmed locally advanced or metastatic DTC that cannot be removed by surgery or radiotherapy, including papillary thyroid cancer, follicular thyroid cancer, hurthle cell thyroid cancer or poorly differentiated thyroid cancer.\n4. At least one measurable lesion according to RECIST 1.1\n5. Radioiodine-refractory (RAI-refractory) differentiated thyroid cancer can be diagnosed when any of the following criteria are met under thyroid-stimulating hormone (TSH) stimulation (\\>30 mU\u002FL) in the absence of exogenous iodine interference:\n\n   * Negative uptake in one or more measurable lesions after receiving I-131 treatment or scanning\n   * One or more measurable lesions that has progressed as per RECIST 1.1 within 14 months of 131I therapy（3.7\\~7.4 GBq or100\\~200 mCi）,despite demonstration of radioiodine avidity at the time of that treatment by pre- or post-treatment scanning.\n   * Cumulative activity of 131I of \\> 22 GBq or 600 mCi, with the last dose administered at least 6 months prior to study entry\n6. Subjects with DTC who failed with or was intolerant to at least one prior tyrosine kinase inhibitor (TKI) therapy. If prior treatment with VEGFR-TKI, no more than two VEGFR-TKIs were allowed.\n7. Recommendation of subject offering archived tissue sample or previous biomarker of MET test report. If archived tumor sample is not available, a fresh biopsy is optional, which need to be taken from needle biopsy or core needle biopsy (fine needle biopsy not allowed). Subjects who cannot provide tissue samples or test reports may still be eligible to participate if the investigator determines a potential clinical benefit from ST-1898 therapy.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n9. TSH-suppression therapy is well tolerated with thyroid stimulating hormone (TSH) \\\u003C 0.5 mU\u002FL;\n10. The patient has adequate organ and bone marrow function as follows:\n\n    * Adequate bone marrow function (without transfusion or colony stimulating factor support within 2 weeks): hemoglobin ≥ 90 g\u002FL, absolute neutrophil count (ANC) ≥ 1.5 ×10\\^9\u002FL and platelets ≥ 100 × 10\\^9\u002FL;\n    * Adequate liver function: Bilirubin ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN if participant has liver metastases);\n    * Adequate renal function: Serum creatinine ≤1.5 ×ULN or creatinine clearance≥50 mL\u002Fmin per the Cockcroft-Gault formula;\n    * Adequate blood coagulation function: International Normalized Ratio (INR) ≤ 1.5 and Activated partial thromboplastin time (APTT) ≤1.5 ULN（except for the prophylactic use of anticoagulants）\n    * Adequate cardiac function: Left ventricular ejection fraction (LVEF) ≥50%;\n    * Participants having≤ 1 + proteinuria or ≥2+ proteinuria with urine protein \\\u003C 1 g\u002F24 hour.\n11. Ability to understand and the willingness to sign a written informed consent document. The results of routine examination during the corresponding window period before screening are acceptable.\n12. Women with child-bearing potential and men must agree to use adequate contraception (e.g., hormonal contraceptives, male or female condom, or abstinence) during the course of the study and for at least 3 months following the last dose of study drug. Women with childbearing potential must have a negative serum pregnancy test within 7 days before first study treatment.\n\nExclusion Criteria:\n\n1. Other histological subtypes of thyroid cancers excluding DTC (such as Anaplastic Thyroid Carcinoma and Medullary Thyroid Carcinoma).\n2. Known hypersensitivity to any component of ST-1898 tablets.\n3. Participants who have received any antitumor treatment within 4 weeks or 5 half-lives of the agent (contingent on the shorter time) prior to the first dose of study drug.\n4. Patients who underwent major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of study drug.\n5. Serious non-healing wound\u002Fulcer\u002Fbone fracture.\n6. ≥ grade 3 bleeding episodes within 6 months prior to first dose of study treatment, or currently ≥ grade 2 hemorrhage, with high bleeding risks (such as coagulation disorders, tracheobronchial infiltration with significant bleeding, active gastrointestinal ulcer and esophageal varices)\n7. Active hemoptysis or more than 0.5 teaspoon (2.5 mL) of hemoptysis per day within 2 months before first dose of study treatment\n8. Subjects with antiplatelet agents treatment (low-dose aspirin ≤100 mg\u002Fday is permitted).\n9. Current or previous severe retinopathy who, in the judgment of the Investigator or specialist, are not suitable for enrollment\n10. Significant cardiovascular impairment, including but not limited to:\n\n    1. Serious arrhythmia or cardiac conduct abnormality, such as degree II-III atrioventricular block or ventricular arrhythmia needs to be treated.\n    2. QTcF interval extension (by the Fridericia formula): male \\>450 ms, female \\>480 ms\n    3. Acute coronary syndrome, stroke, deep vein thrombosis, pulmonary- thromboembolism, arterial thrombosis, congestive heart failure, aortic dissection etc.\n    4. New York Heart Association Class ≥ II\n    5. Uncontrolled hypertension, as defined by a sustained blood pressure (BP) \\> 140\u002F90 mmHg.\n11. Known brain metastasis unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and with a stable dose of corticosteroid treatment before first dose of study treatment.\n12. Interstitial lung disease or radiation pneumonia in need of glucocorticoids intervention\n13. Subjects with malignant tumors in the last 5 years (not including non-melanoma skin cancer, breast cancer or cervical cancer in situ, and Non-Muscle-invasive bladder cancer have been cured)\n14. Receiving chronic concomitant treatment of strong CYP3A4 inducers, CYP3A4 inhibitors or CYP3A4 substrate with a narrow therapeutic window within 2 weeks prior to study drug administration,\n15. Prior treatment of BRAF inhibitors.\n16. Has not recovered from toxicities caused by prior therapy to CTCAE ≤Grade 1 (except for ≤Grade 2 peripheral neuropathy, alopecia, and other events judged tolerable by the Investigator and without safety risks).\n17. HIV antibodies or Treponema pallidum antibodies positive, active hepatitis B (HBV-DNA≤ 2×ULN allowed to enroll), hepatitis C virus (HCV) antibody-positive and HCV-RNA- positive, or other active hepatitis, clinically significant moderate-to-severe cirrhosis. Prophylactic antiviral therapy other than interferon are allowed.\n18. Acute bacterial, viral or fungal infections (any infection requiring systemic treatment)\n19. Females who are pregnant or breastfeeding.\n20. Drug or alcohol dependents.\n21. Significant disorder of neurology or mental disease or poorly compliance.\n22. Subjects with oral administration impossible, or in the conditions of malabsorption as determined by the investigator, such as dysphagia and intestinal obstruction, etc..\n23. Uncontrolled pleural effusion, pericardial effusion, abdominal effusion requiring frequent drainage or medical intervention (clinically significant recurrence requiring additional intervention within 2 weeks after intervention, excluding exudate cytology) before first dose of study treatment.\n24. Any history of other serious systemic diseases, or any other reason that might interfere with participation in trial or interfere with interpretation of trial results, in the judgement of the Investigator, that are not qualified to participate in this trial.",{"count":52,"type":20},60,[24],"ST-1898, a multi-targeted tyrosine kinase inhibitor, has demonstrated strong inhibitory activity for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT, etc. The primary purpose of this study is to evaluate the efficacy of ST-1898 tablets in patients with locally advanced or metastatic RAIR-DTC after failure of at least first-line TKI systemic therapy. All subjects will receive ST-1898 180 mg orally once daily until disease progression or intolerable toxicity.",[56],"Differentiated Thyroid Carcinoma",[58],"ST-1898，Differentiated Thyroid Cancer",{"date":34,"type":35},{"date":61,"type":35},"2023-11-15",{"date":63,"type":20},"2027-12",{"name":41,"class":42},""]