[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Jiatan Pharmatech Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":186},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,40,75,100,124,147,167],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100623086","phase-3-a-phase-iii-clinical-study-of-wx390-combined-with-toripalimab-versus-investigators-choice-of-therapy-in-patients-with-recurrent-or-metastatic-cervical-cancer-who-have-failed-prior-platinum-based-treatment-100623086",false,"NCT07392060","A Phase III Clinical Study of WX390 Combined With Toripalimab Versus Investigator's Choice of Therapy in Patients With Recurrent or Metastatic Cervical Cancer Who Have Failed Prior Platinum-Based Treatment","A Randomized, Open-Label, Controlled, Multicenter Phase III Clinical Study of WX390 Combined With Toripalimab Versus Investigator's Choice of Therapy in Patients With Recurrent or Metastatic Cervical Cancer Who Have Failed Prior Platinum-Based Treatment","Inclusion Criteria:\n\n1. The subject voluntarily participates in this clinical study, has provided signed informed consent prior to the initiation of any screening procedures, and is able to understand and comply with the study requirements.\n2. Aged 18 to 75 years (inclusive, calculated on the day of signing the informed consent form).\n3. Histologically or cytologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.\n4. Not eligible for curative treatment with surgery, radiotherapy, or chemoradiotherapy.\n\n   Willing to undergo a biopsy during the screening period to provide fresh tumor tissue for PD-L1 and PIK3CA mutation testing; if a biopsy is not feasible, archived tumor tissue samples (formalin-fixed, paraffin-embedded (FFPE) blocks or unstained FFPE slides) may be provided for PD-L1 testing. All testing will be performed at a central laboratory. If the provided tumor tissue sample is deemed unsuitable by the central laboratory for evaluating PD-L1 expression and\u002For PIK3CA mutation status, the subject cannot be enrolled.\n5. Must have at least one measurable lesion as per RECIST v1.1 criteria. Previously irradiated lesions with confirmed progression on imaging may be considered as target lesions.\n6. ECOG performance status of 0 or 1.\n7. Able to swallow tablets normally.\n8. Life expectancy of ≥3 months.\n\nExclusion Criteria:\n\n1. Previous treatment with any PI3K, AKT, or mTOR inhibitor, or prior treatment with toripalimab.\n2. Patients with type 1 or type 2 diabetes mellitus.\n3. History of interstitial lung disease, drug-induced pneumonitis, pulmonary fibrosis, pneumoconiosis, or radiation pneumonitis (patients with only radiographic evidence of radiation pneumonitis and not requiring corticosteroid therapy may be enrolled). Patients with active pneumonia during screening, severely impaired lung function, or other conditions that may interfere with the detection and management of suspected drug-related pulmonary toxicity.\n4. Radiographic evidence of tumor invasion into the bladder or rectum, deemed by the investigator to pose a risk of perforation; or a known history of female reproductive tract fistula (e.g., vesicovaginal fistula, urethrovaginal fistula, cervicovesical fistula, etc.). Patients may be enrolled if the perforation or fistula has been treated with diversion surgery, resection, or repair, and the condition is considered resolved or controlled by the investigator.\n5. Currently active bleeding, intra-abdominal abscess, or intestinal obstruction requiring clinical intervention.\n6. CT\u002FMRI or other imaging shows tumor invasion or encasement of major blood vessels, indicating a high risk of bleeding.\n7. Current clinically significant hydronephrosis. Patients may be enrolled if hydronephrosis is relieved by nephrostomy or ureteral stent placement.\n8. Patients with refractory nausea and vomiting, dysphagia, gastrointestinal disorders affecting drug absorption (e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome), or other malabsorption conditions.\n9. History of severe allergy, hypersensitivity, or other anaphylactic reactions to the investigational product or any of its excipients.\n10. Administration of a live vaccine within 4 weeks prior to randomization or planned administration during the study.\n11. Patients with active autoimmune disease, history of bone marrow or solid organ transplantation, suicidal tendency, alcohol or drug dependence, clear history of neurological or psychiatric disorders, or other conditions that, in the investigator's assessment, may contraindicate the use of the investigational product, compromise the interpretation of study results, or result in forced discontinuation from the study.","ALL","18 Years","75 Years",{"count":20,"type":21},440,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a Randomized, Open-Label, Controlled, Multicenter Phase III Clinical Study to evaluate the efficacy of WX390 in combination with toripalimab versus investigator's choice of therapy in patients with recurrent or metastatic cervical cancer who have failed at least one prior platinum-based systemic therapy, as assessed by overall survival (OS).",[27],"Cervical Cancer Metastatic","NOT_YET_RECRUITING","2026-02-04",{"date":31,"type":32},"2026-02-06","ACTUAL",{"date":34,"type":21},"2026-02-28",{"date":36,"type":21},"2030-06-30",{"name":38,"class":39},"Shanghai Jiatan Pharmatech Co., Ltd","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100502639","phase-3-a-phase-iii-study-of-oral-sudapyridine-wx-081-tablets-in-rifampicin-resistant-pulmonary-tuberculosis-patients-100502639","NCT05824871","A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients","A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Oral Sudapyridine (WX-081) Tablets in Patients With Rifampicin-Resistant Pulmonary Tuberculosis","WISH","Inclusion Criteria:\n\n* • Body mass index (BMI) and body weight of subjects: 15.0≤BMI≤28.0 kg\u002Fm2, and 40kg≤ body weight ≤90kg;\n\n  * For clinically diagnosed patients with tuberculosis whose drug sensitivity test has proved to be at least resistant to rifampicin, phenotypic or molecular drug sensitivity test results within 3 months before the subject signs informed consent can be accepted;\n  * Direct sputum smear positive for acid-fast bacilli (AFB at least 1+);\n  * Willing to discontinue all previous anti-tuberculosis drugs and accept a 7-day washout period;\n  * Non-lactating and pregnant women who agree to use contraception throughout the treatment; Or the male patient's spouse agrees to use contraception throughout the treatment.\n\nExclusion Criteria:\n\n* • Allergic to any study drug or its ingredients;\n\n  * A history of alcohol dependence or drug abuse;\n  * With hematogenous disseminated pulmonary tuberculosis or extrapulmonary tuberculosis;\n  * Drug susceptibility test before screening showed resistance to more than 4 of the 8 antituberculosis drugs in this study;\n  * Have taken Bedaquiline before;\n  * HIV-positive patients;\n  * Laboratory obvious abnormalities;\n  * A history of pointy torsion ventricular tachycardia or cardiac risk factors for pointy torsion ventricular tachycardia;\n  * Repeated QTcF intervals \\> 450ms; Clinically significant ventricular arrhythmias that may require medical or surgical treatment;\n  * Documented cardiovascular diseases;\n  * Peripheral neuropathy CTCAE grade 3 or grade 4; Grade 1 or grade 2 neuropathy that the investigator believes is likely to progress\u002Fworsen over the course of the study; optic neuritis;\n  * Any serious cardiovascular, kidney, liver, blood, tumor, endocrine and metabolic, autoimmune or rheumatic diseases.","65 Years",{"count":50,"type":21},450,[24],"This is a multicenter, randomized, double-blind, active-controlled Phase III study to evaluate the efficacy and safety of Sudapyridine (WX-081) combined with a background regimen (BR) in patients with rifampicin-resistant pulmonary tuberculosis.\n\nApproximately 450 participants will be screened over a period of up to 2 weeks and randomized in a 2:1 ratio to receive either Sudapyridine or bedaquiline, in combination with placebo tablets and BR, for 24 weeks. After the treatment period, participants will enter a background regimen period up to Week 72, during which they will continue to receive BR.\n\nA subset of participants will be included in the C-QT sub-study to assess intensive PK sampling and 12-lead ECG evaluations on Day 1 pre-dose, Day 14, and Week 24.\n\nThe study aims to provide robust data to support the use of Sudapyridine as a treatment option for rifampicin-resistant pulmonary tuberculosis.",[54,55],"Rifampin-Resistant Pulmonary Tuberculosis","Tuberculosis, Multidrug-Resistant (MDR-TB)",[57,58,59,60,61,62,63,64],"Rifampin-Resistant Tuberculosis","Multidrug-Resistant Tuberculosis (MDR-TB)","Pulmonary Tuberculosis","Sudapyridine (WX-081)","Bedaquiline","Antitubercular Agents","Randomized Controlled Trial","Background Regimen Therapy","RECRUITING","2025-06-25",{"date":68,"type":32},"2025-06-29",{"date":70,"type":32},"2022-09-02",{"date":72,"type":21},"2026-10-22",{"name":38,"class":39},2,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":16,"minAge":17,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100569968","phase-1-drug-drug-interaction-and-food-effect-of-sudapyridinewx-081-with-itraconazole-and-rifampin-in-healthy-chinese-adults-100569968","NCT06701136","Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) With Itraconazole and Rifampin in Healthy Chinese Adults","A Clinical Study to Evaluate the Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) Tablet With Itraconazole and Rifampin in Healthy Chinese Adult Volunteers","WX081-DDI","Inclusion Criteria:\n\n* Participants must be healthy male or female adults of Chinese nationality, aged 18-50 years (including 18 and 50).\n\nMale participants must weigh at least 50 kg, and female participants at least 45 kg. Body mass index (BMI) should be between 18 and 28 kg\u002Fm² (including 18 and 28), and weight (kg)\u002Fheight (m²).\n\nParticipants must undergo a comprehensive physical examination, 12-lead ECG, vital signs assessment, and laboratory tests. Results must be normal or deemed clinically insignificant by the investigator, meeting the following:\n\n12-lead ECG must show QTcF ≤ 450 ms (≤ 200 ms for A Study), QRS duration ≤ 120 ms, and PR interval ≤ 200 ms. PR elongation may allow entry if deemed clinically insignificant by the investigator.\n\nParticipants (including their partners) must agree to use effective contraception from the date of screening to 6 months after the last study drug administration and must avoid sperm\u002Fegg donation during this period.\n\nExclusion Criteria:\n\n* Participants with central nervous system, cardiovascular, gastrointestinal, urinary, respiratory, musculoskeletal, endocrine, or hematologic diseases or other chronic\u002Facute diseases, or those with significant surgical history affecting drug absorption, distribution, metabolism, or excretion.\n\nParticipants with conditions that increase the risk of QT prolongation, or with a family history of sudden cardiac death (\\\u003C40 years old) or other hereditary diseases.\n\nClinically significant laboratory abnormalities at screening, including:\n\nALT\u002FAST\u002FTBIL values exceeding 2 times the upper limit of normal. Estimated creatinine clearance (ClCr) \\\u003C 60 mL\u002Fmin. Participants with urinary system disorders. Use of any prescription or over-the-counter drugs, supplements, or herbal products within 2 weeks before dosing that may affect the study evaluation.\n\nKnown allergy to Sudapyridine (WX-081) or other related compounds. Participants positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus antibody (Anti-HCV), anti-HIV antibody, or syphilis antibody.\n\nHistory of alcohol or drug abuse:\n\nAlcohol: ≥14 units per week; a unit equals 285 mL beer or 100 mL wine. Participants who smoke more than 5 cigarettes\u002Fday and cannot stop during the study.\n\nDonation of blood exceeding 400 mL within 1 month prior to the study. Participants enrolled in other drug trials within 3 months before the study. Use of CYP3A4 or P-gp inhibitors\u002Finducers within 28 days prior to the study (e.g., itraconazole, rifampin).\n\nUnwillingness to avoid grapefruit, pomelo, or other food\u002Fdrinks affecting drug metabolism during the study.\n\nParticipants with a history of intestinal surgery affecting drug absorption. Women who are pregnant or lactating or intending to become pregnant. Participants deemed unsuitable by the investigator due to other reasons.",true,"50 Years",{"count":86,"type":21},16,[88],"PHASE1","The goal of this clinical trial is to learn how Sudapyridine (WX-081) tablets interact with other drugs and how food intake affects its pharmacokinetics in healthy Chinese adults. The main questions it aims to answer are:\n\nHow does itraconazole (a strong CYP3A inhibitor) affect the pharmacokinetics of Sudapyridine? How does rifampin (a strong CYP3A inducer) affect the pharmacokinetics of Sudapyridine? How does food intake influence the pharmacokinetics of Sudapyridine?\n\nParticipants will:\n\nTake Sudapyridine alone, with itraconazole, with rifampin, and under fed and fasting conditions based on a predefined sequence.\n\nAttend multiple clinic visits for blood sample collection and safety evaluations.\n\nResearchers will compare the pharmacokinetic parameters of Sudapyridine under these conditions to determine the impact of drug-drug interactions and food.",[91],"Rifampicin-Resistant Pulmonary Tuberculosis Patients","2025-02-10",{"date":94,"type":32},"2025-02-12",{"date":96,"type":21},"2025-05-12",{"date":98,"type":21},"2026-02-12",{"name":38,"class":39},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":107,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100525686","phase-2-a-study-of-wx390-combined-with-toripalimab-in-patients-with-advanced-gastric-type-endocervical-adenocarcinoma-with-stk11-mutations-100525686","NCT06124963","A Study of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations","A Phase II Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations","Inclusion Criteria:\n\n* ≥18 years of age\n* Histological or cytological confirmed advanced Gastric-type Endocervical Adenocarcinoma.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Life expectancy of more than 3 months\n* At least one measurable lesion according to RECIST 1.1\n* Adequate organic function\n* Signed and dated informed consent\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 30 days prior to the initiation of investigational treatment\n* Major surgery within 30 days prior to the initiation of study treatment\n* Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment\n* Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for alopecia)\n* Patients who are suffering active interstitial lung disease\n* Evidence of ongoing or active serious infection\n* History of human immunodeficiency virus (HIV) infection or active hepatitis B or C infection\n* Inability to take medication orally\n* Abuse of alcohol or drugs\n* People with cognitive and psychological abnormality or with low compliance\n* Pregnant or lactating women","FEMALE",{"count":109,"type":21},20,[111],"PHASE2","The goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390 combined with Toripalimab in patients with advanced Gastric-type Endocervical Adenocarcinoma with STK11 mutations. The main questions it aims to answer are:\n\n* Pharmacokinetic (PK) characteristics of WX390 combined with Toripalimab treatment.\n* Safety and preliminary in combined therapy. Participants will be treated with WX390 orally and Toripalimab intravenously, and follow the efficacy and safety evaluation according to the protocol.",[114],"Gastric Type Adenocarcinoma (GAS) With STK11 Mutation","2024-12-09",{"date":117,"type":32},"2024-12-10",{"date":119,"type":32},"2023-08-25",{"date":121,"type":21},"2026-12-09",{"name":38,"class":39},1,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":83,"sex":131,"minAge":17,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":123},"100569966","phase-1-pharmacokinetic-study-of-sudapyridinewx-081in-healthy-chinese-subjects-100569966","NCT06701110","Pharmacokinetic Study of Sudapyridine（WX-081）in Healthy Chinese Subjects","Pharmacokinetics and Mass Balance Study of WX-081 (Sudapyridine) in Healthy Chinese Volunteers","Inclusion Criteria:\n\n* Healthy adult males. Age: 18-45 years (inclusive). Body weight: BMI between 19.0 and 26.0 kg\u002Fm² (inclusive), with body weight not less than 50.0 kg.\n\nVoluntarily signed the informed consent form. Able to communicate effectively with investigators and comply with the study protocol.\n\nExclusion Criteria:\n\n* Clinically significant abnormalities identified through physical examination, vital signs, laboratory tests (e.g., blood count, biochemistry, troponin, coagulation function, urinalysis, fecal occult blood), thyroid function, 12-lead ECG, chest X-ray, rectal examination, or abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidney).\n\nProlonged corrected QT interval (QTcF) \\> 450 msec on 12-lead ECG. Positive results for hepatitis B surface antigen (HBsAg or HBeAg), hepatitis C antibody (HCV-Ab), syphilis antibody, or HIV antigen\u002Fantibody (HIV-Ag\u002FAb).\n\nUse of drugs that inhibit or induce hepatic enzymes or transporters within 30 days prior to screening.\n\nUse of prescription or over-the-counter medications, herbal remedies, or dietary supplements (e.g., vitamins, calcium) within 14 days prior to screening.\n\nAny clinically significant disease or condition that may affect study results, including but not limited to cardiovascular, respiratory, endocrine, neurological, gastrointestinal, urinary, hematological, immune, psychiatric, or metabolic disorders.\n\nConditions that could affect drug absorption, such as a history of gastric surgery (e.g., gastrectomy, gastric bypass), gallbladder removal, or inflammatory bowel disease.\n\nHistory of organic heart disease, heart failure, myocardial infarction, angina, unexplained arrhythmia, ventricular tachycardia, atrioventricular block, long QT syndrome, or family history of sudden cardiac death due to cardiac reasons.\n\nMajor surgery within 6 months prior to screening or incomplete surgical wound healing.\n\nKnown hypersensitivity or allergy to two or more substances, or potential allergy to the investigational drug or its excipients (e.g., lactose, low-substituted hydroxypropyl cellulose, sodium lauryl sulfate, silicon dioxide, magnesium stearate).\n\nHemorrhoids or perianal conditions with regular or current rectal bleeding.","MALE","45 Years",{"count":134,"type":21},10,[88],"This single-center, open-label, non-randomized study aims to evaluate the pharmacokinetics, mass balance, and metabolic pathways of WX-081 (Sudapyridine) following a single oral dose of \\[U-14C\\] WX-081 in healthy Chinese male volunteers. A total of 6-10 subjects will be enrolled to obtain complete samples and data from at least six participants. Biological samples, including blood, plasma, urine, and feces, will be collected over a specified time period. The study will assess pharmacokinetic parameters, excretion pathways, and identify major metabolites contributing to over 10% of plasma exposure.",[138],"TB","2024-11-20",{"date":141,"type":32},"2024-11-22",{"date":143,"type":32},"2024-09-04",{"date":145,"type":21},"2026-06-12",{"name":38,"class":39},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":123},"100525117","phase-1-a-study-of-wx390-combined-with-toripalimab-in-patients-with-advanced-solid-tumors-100525117","NCT06117566","A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors","A Phase Ib\u002FIIa Study to Evaluate the Safety and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* ≥18 years of age\n* Histological or cytological confirmed advanced solid tumor, standard regimen failed or no standard regimen available\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Life expectancy of more than 3 months\n* At least one measurable lesion according to RECIST 1.1\n* Adequate organ function，\n* Signed and dated informed consent\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 30 days prior to the initiation of investigational treatment\n* Major surgery within 30 days prior to the initiation of study treatment\n* Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment\n* Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for alopecia)\n* Patients who are suffering active interstitial lung disease\n* Evidence of ongoing or active serious infection\n* History of human immunodeficiency virus (HIV) infection or active hepatitis B or C infection\n* Inability to take medication orally\n* Abuse of alcohol or drugs\n* People with cognitive and psychological abnormality or with low compliance\n* Pregnant or lactating women",{"count":155,"type":21},100,[88,111],"The goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390 combined with Toripalimab in patients with advanced solid tumors. The main questions it aims to answer are:\n\n* the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of WX390;\n* safety and preliminary in combined therapy. Participants will be treated with WX390 orally and Toripalimab intravenously, and follow the efficacy and safety evaluation according to the protocol.",[159],"Solid Tumor",{"date":161,"type":32},"2024-11-25",{"date":163,"type":32},"2022-11-18",{"date":165,"type":21},"2025-11-09",{"name":38,"class":39},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":107,"minAge":17,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":185,"locationsCount":123},"100525115","phase-2-a-study-of-wx390-in-patients-with-advanced-solid-tumors-100525115","NCT06117540","A Study of WX390 in Patients With Advanced Solid Tumors","An Open-label, Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of WX390 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* ≥18 years of age\n* Histological or cytological confirmed advanced solid tumor, standard regimen failed\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Life expectancy of more than 3 months\n* At least one measurable lesion according to RECIST 1.1\n* Adequate organ function\n* Signed and dated informed consent\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 30 days prior to the initiation of investigational treatment\n* Major surgery within 30 days prior to the initiation of study treatment\n* Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for alopecia)\n* Patients who are suffering active interstitial lung disease\n* Evidence of ongoing or active serious infection\n* Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment\n* Active hepatitis B or C infection\n* Inability to take medication orally\n* Abuse of alcohol or drugs\n* Pregnant or lactating women\n* People with cognitive and psychological abnormality or with low compliance",{"count":175,"type":21},70,[111],"The goal of this clinical trial is to evaluate the efficacy and safety of WX390 in patients with advanced solid tumors. The main questions it aims to answer are:\n\n* PFS, OS, DoR at week 48;\n* antitumor effects at week 24 and week 48. Participants will be treated with WX390 orally, and follow the efficacy and safety evaluation according to the protocol.",[159],"2024-11-18",{"date":181,"type":32},"2024-11-19",{"date":183,"type":32},"2021-05-11",{"date":145,"type":21},{"name":38,"class":39},""]