[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":109},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,66,83],{"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":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100637602","phase-1-study-of-lt-010391-in-participants-with-kras-g12d-mutant-solid-tumors-100637602",false,"NCT07624214","Study of LT-010391 in Participants With KRAS G12D-Mutant Solid Tumors","A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-010391 Tablets in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation","Inclusion Criteria:\n\n* Participants with histologically or cytologically confirmed advanced solid tumors harboring a KRAS G12D mutation;\n* Failed standard therapy, intolerant to standard therapy, or no standard therapy is available;\n* ECOG Performance Status of 0 or 1;\n* Adequate organ function\n\nExclusion Criteria:\n\n* History of ≥2 primary malignancies within 5 years prior to signing informed consent, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or other malignancies considered cured;\n* Primary central nervous system (CNS) tumors\n* leptomeningeal metastases, brainstem metastases, or spinal cord compression confirmed by imaging (regardless of symptoms) Other inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},198,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study is to evaluate the safety and tolerability of of LT-010391 as monotherapy in participants with KRAS G12D mutant advanced solid tumors",[26,27,28,29],"Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Pancreatic Ductal Adenocarcinoma (PDAC)","Advanced Solid Tumors","NOT_YET_RECRUITING","2026-05-31",{"date":33,"type":34},"2026-06-03","ACTUAL",{"date":36,"type":20},"2026-07",{"date":38,"type":20},"2029-04",{"name":40,"class":41},"Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100587715","phase-1-a-study-to-explore-the-safety-tolerability-efficacy-and-pharmacokinetics-of-lt-002-158-tablets-in-chinese-adult-subjects-with-atopic-dermatitis-100587715","NCT06931990","A Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-002-158 Tablets in Chinese Adult Subjects With Atopic Dermatitis","A Phase Ic\u002FII Clinical Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of Multiple Oral Doses of LT-002-158 Tablets in Chinese Adult Subjects With Atopic Dermatitis","Inclusion Criteria:\n\n1. When signing the informed consent form, the age range is 18 to 75 years old (including threshold), and there is no gender limit.\n2. Body mass index (BMI) is between 17.5 and 40.0 kg\u002Fm2 (inclusive), with a weight of ≥ 45.0 kg.\n3. Insufficient response or intolerance to topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within the last 6 months of randomization; Insufficient response is defined as the failure to achieve and maintain remission or low disease activity (equivalent to vIGA 0=complete clearance to 2=mild) despite the use of a moderate to high efficacy TCS regimen (± TCI if applicable) for at least 28 days or the longest duration recommended in the drug prescription information (e.g. 14 days for super potent TCS), whichever is shorter.\n4. Subjects must use topical moisturizers (moisturizers) daily for at least 7 consecutive days prior to the baseline visit. Participants should continue to use daily moisturizers during the study period.\n5. Female and male participants with fertility and their partners had no fertility plans during the study period and within 6 months after the last dose, and agreed to take effective contraceptive measures.\n6. Understand and voluntarily sign written informed consent; Willing and able to complete planned visits, treatments, examinations, and other procedures (such as dietary requirements, diary card recording, and collection) according to the requirements of the plan.\n\nExclusion Criteria:\n\n1. Merge other skin diseases that may interfere with the study evaluation, such as psoriasis, tinea corporis, lupus erythematosus, etc.\n2. Systemic anti infective therapy is required for active or chronic recurrent infections within the 4 weeks prior to the baseline visit.\n3. Known or suspected to have a history of immune deficiency disease, other immune related diseases, invasive opportunistic infections or associated active tuberculosis.\n4. History of severe or recurrent herpes virus infection, such as herpetic encephalitis, disseminated herpes, etc.\n5. History of important organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell\u002Fbone marrow transplantation.\n6. After inquiry, there is a history of lymphoproliferative diseases; Or currently suffering from malignant tumors or having a history of malignant tumors (excluding squamous cell carcinoma in situ of the skin, basal cell carcinoma, and cervical cancer in situ, which have achieved complete remission after radical treatment for more than 5 years without any signs of recurrence).\n7. A family history of sudden death or long QT syndrome, or subjects with a history of congenital or drug-induced long QT syndrome.","75 Years",{"count":52,"type":20},24,[23,54],"PHASE2","This study is an Ic\u002FII phase clinical trial conducted in Chinese subjects with moderate to severe atopic dermatitis. The phase Ic study is a randomized, open label, parallel group design, mainly evaluating the safety and tolerability of LT-002-158 tablets in subjects with moderate to severe atopic dermatitis. The phase II study is a randomized, double-blind, placebo-controlled, parallel group design, with a single arm design for extended treatment, mainly exploring the efficacy of LT-002-158 tablets in the treatment of moderate to severe atopic dermatitis subjects.",[57],"Atopic Dermatitis (AD)","2025-04-09",{"date":60,"type":34},"2025-04-17",{"date":62,"type":20},"2025-04-15",{"date":64,"type":20},"2025-12-30",{"name":40,"class":41},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":81,"leadSponsor":82,"locationsCount":4},"100587716","phase-1-a-study-to-explore-the-safety-tolerability-efficacy-and-pharmacokinetics-of-lt-002-158-tablets-in-chinese-adult-patients-with-hidradenitis-suppurativa-100587716","NCT06932003","A Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-002-158 Tablets in Chinese Adult Patients With Hidradenitis Suppurativa","A Phase Ic\u002FII Clinical Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of Multiple Oral Doses of LT-002-158 Tablets in Chinese Adult Patients With Hidradenitis Suppurativa","Inclusion Criteria:\n\n1. Male or female aged 18 to 75 years (inclusive), with body mass index (BMI) between 17.5 and 40.0 kg\u002Fm² (inclusive) and body weight ≥45.0 kg;\n2. Diagnosis of hidradenitis suppurativa (HS) with disease duration of at least 6 months prior to enrollment;\n3. Have inadequate response or intolerance to prior HS treatments and are suitable candidates for this study on investigator's judgment;\n4. Total count of abscesses and inflammatory nodules ≥4 at baseline;\n5. No pregnancy plans during the study and for 6 months after the last dose, with agreement to use effective contraception methods;\n6. Understand and voluntarily sign the informed consent form; Willing and able to to complete patient diary entries as required by the protocol;\n7. The subject is willing and able to comply with all protocol requirements by investigator's judgment.\n\nExclusion Criteria:\n\n1. Presence of \\>20 fistulas or deeply extensive coalescing lesions;\n2. Other significant dermatological conditions that may interfere with efficacy evaluation or require concomitant treatment (e.g., seborrheic dermatitis), or any skin conditions deemed by investigators as potentially affecting study assessments (e.g., tattoos, scars);\n3. Any of the following comorbidities:\n\n   1. Active tuberculosis;\n   2. Active hepatitis B\u002FC, syphilis, or human immunodeficiency virus (HIV) infection;\n   3. Severe cardiovascular diseases including: Congestive heart failure (NYHA class ≥II); Angina pectoris \\>grade 1; Known structural heart disease; Major cardiovascular events within screening period (myocardial infarction, unstable angina, acute coronary syndrome, stroke or transient ischemic attack, etc.); Ventricular fibrillation; TDP; atrial fibrillation; Unexplained syncope of non-cardiac origin;\n   4. Immunodeficiency or immune-related disorders (organ\u002Fbone marrow transplantation, splenectomy, IgG4-related disease, vasculitis, etc.) or active autoimmune diseases requiring treatment (psoriasis, atopic dermatitis, rheumatoid arthritis, etc.);\n   5. History or symptoms of malignancy in any organ system within 5 years prior to screening, regardless of treatment status or evidence of recurrence\u002Fmetastasis (except appropriately treated non-metastatic cutaneous carcinoma in situ or cervical basal\u002Fsquamous cell carcinoma in situ);\n   6. Gastrointestinal disorders or surgeries (gastrectomy, gastric bypass, etc.) that may affect oral drug absorption;\n4. Family history of sudden death or long QT syndrome, or personal history of congenital\u002Fmedication-induced long QT syndrome;\n5. Any of the following laboratory abnormalities:\n\n   1. Estimated glomerular filtration rate (eGFR) or creatinine clearance (CrCl) \\\u003C60 mL\u002Fmin\u002F1.73m²;\n   2. Total bilirubin ≥1.5×upper limit of normal (ULN);\n   3. ALT ≥1.5×ULN or AST ≥1.5×ULN;\n   4. Hemoglobin \\\u003C9.0 g\u002FdL, WBC \\\u003C3.0×10⁹\u002FL, neutrophils \\\u003C1.5×10⁹\u002FL, lymphocytes \\\u003C0.75×10⁹\u002FL, platelets \\\u003C100×10⁹\u002FL;\n   5. Serum potassium, magnesium, or calcium below lower limit of normal;\n   6. QTcF \\>450 ms or QRS \\>110 ms on screening ECG;\n   7. Blood pressure ≥150\u002F90 mmHg despite antihypertensive treatment;\n6. Use of adalimumab or other biologics within 8 weeks or 5 half-lives prior to first dose (whichever longer) (≤20% of enrolled subjects may have prior biologic exposure without treatment failure);\n7. Systemic antibiotic therapy within 2 weeks or systemic retinoid therapy within 4 weeks prior to first dose.",{"count":74,"type":20},12,[23,54],"This study is a Phase Ic\u002FII clinical trial conducted in Chinese patients with moderate-to-severe hidradenitis suppurativa (HS), aiming to evaluate the safety and efficacy of LT-002-158 tablets in the treatment of moderate-to-severe HS.\n\nThe study consists of two parts. The Phase Ic portion employs an open-label, single-arm design to primarily investigate the safety and tolerability of LT-002-158 tablets in patients with moderate-to-severe HS. The Phase II study adopts a randomized, double-blind, placebo-controlled, parallel-group design, with an open-label, single-arm extension phase, to primarily assess the therapeutic efficacy of LT-002-158 tablets in patients with moderate-to-severe HS.",[78],"Hidradenitis Suppurativa (HS)",{"date":60,"type":34},{"date":62,"type":20},{"date":64,"type":20},{"name":40,"class":41},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":16,"minAge":17,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":42},"100522415","phase-1-a-single-and-multiple-ascending-dose-trial-of-lt-002-158-tablets-in-healthy-adult-volunteers-100522415","NCT06082323","A Single and Multiple Ascending Dose Trial of LT-002-158 Tablets in Healthy Adult Volunteers","A Phase 1，Randomized, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered LT-002-158 in Healthy Adult Volunteers","Inclusion Criteria:\n\n* 1\\) Healthy volunteers who fully understand the content, process, and possible adverse event of the study and capable of giving written informed consent form.\n\n  2\\) Male or female between 18 and 55 years of age (inclusive), at the time of signing the informed consent form.\n\n  3\\) Body mass index (BMI) range within 18\\~30 kg\u002Fm2 (inclusive), and body weight of ≥ 50.0 kg for male and ≥ 45.0 kg for female.\n\n  4\\) Healthy volunteers who must be confirmed as negative in the SARS-CoV-2 test on Day -2 (admission).\n\n  5\\) Healthy volunteers with no significant medical history judged by the Investigator and in good health, fully physical examinations, vital signs, 12-lead electrocardiograms (12-ECGs), clinical laboratory tests (hematology, urinalysis, blood chemistry and coagulation test), serum virology test.\n\n  6\\) Females must be non- pregnant, non- lactating and must have negative serum pregnancy test at screening. Women of child bearing potential and males must be willing to use highly effective acceptable forms of contraception from screening to 6 months after the last study drug administration. Males and females must be willing to avoid donating sperm or egg respectively during the study period and 6 months after the last dose of IP.\n\n  7\\) All HVs who must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Healthy volunteers with history of allergy, including anaphylaxis to food, drugs, or are allergic to any component of the IP considered clinically significant in the Investigator's judgment.\n2. Healthy volunteers who are vegans or have medical dietary restrictions.\n3. Healthy volunteers with clinically relevant history of respiratory, immunological, dermatological, connective tissue, lymphatic, metabolism, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, urinary, endocrine, neurologic disorders, psychiatric, and\u002F or any other conditions, judged by the Investigator, that would make the healthy volunteer unsuitable for this study.\n4. Healthy volunteers who have acute GI symptoms at screening or admission (e.g., nausea, vomiting, diarrhea, heartburn).\n5. Healthy volunteers who have an acute infection such as influenza at screening or admission.\n6. Healthy volunteers who have increased risk of infection.\n\n   1. With history and\u002For presence of tuberculosis; positive result for IFN-γ release assay (IGRA) (i.e., QuantiFERON TB-Gold), the test may be repeated if the initial test result is indeterminate. Volunteers who have resided in regions where tuberculosis or mycosis are endemic during 90 days before screening or who intend to visit such a region during the duration of the study.\n   2. HV who engage in high risk unsafe sexual practices.\n   3. With active malignancy or neoplastic disease in the previous 5 years other than superficial basal cell carcinoma.\n   4. With a disease history suggesting abnormal immune function.",true,"55 Years",{"count":93,"type":20},127,[23],"LT-002-158 is an oral IRAK4 protein degrader being developed for the treatment of autoimmune disease and inflammation including Hidradenitis Suppurativa and Atopic Dermatitis. This first-in-human (FIH) study will characterize the safety, tolerability and the pharmacokinetics\u002Fpharmacodynamics (PK\u002FPD) of a single ascending dose and multiple ascending doses of LT-002-158 in healthy volunteers. The effects of food on the pharmacokinetics of LT-002-158 will also be assessed in healthy volunteers.",[97,98,99],"Healthy Volunteer","Hidradenitis Suppurativa","Atopic Dermatitis","RECRUITING","2025-02-16",{"date":103,"type":34},"2025-02-19",{"date":105,"type":34},"2024-06-13",{"date":107,"type":20},"2025-06-01",{"name":40,"class":41},""]