[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Heronova Pharmaceuticals\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100625048","phase-1-a-study-of-dc6001-tablet-in-healthy-chinese-adult-subjects-100625048",false,"NCT07417566","A Study of DC6001 Tablet in Healthy Chinese Adult Subjects","A Randomized, Double-Blind, Parallel Placebo-Controlled, Single and Multiple Ascending Dose Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of Oral DC6001 Tablet in Healthy Chinese Adult Subjects","Inclusion Criteria:\n\n1. Healthy volunteers aged 18-55 years (inclusive) at the time of signing the informed consent form, regardless of gender;\n2. Male subjects with a body weight ≥ 50.0 kg and female subjects with a body weight ≥ 45.0 kg; BMI ranging from 19.0 to 28.0 kg\u002Fm² (inclusive of critical values);\n3. Women of childbearing potential (WOCBP) or male subjects must agree to have no childbearing plans and voluntarily adopt effective contraceptive measures for 6 months from pre-screening to the last administration of the study drug, with no plans for sperm or egg donation. For WOCBP: The serum pregnancy test result of WOCBP must be negative before the first administration;\n4. No history of major diseases; physical examination, vital signs, 12-lead electrocardiogram (ECG), chest X-ray, and laboratory test results during screening are normal, or slightly exceed the normal reference range but are deemed clinically insignificant by the investigator;\n5. Subjects are able to maintain good communication with the investigator, comply with all requirements of the clinical trial, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Subjects with clinically significant abnormalities or diseases occurring within 1 week prior to screening or currently present that require exclusion;\n2. Subjects with digestive system diseases affecting the absorption of fat-soluble vitamins occurring within 3 months prior to screening or currently present;\n3. Subjects with diseases related to vitamin A deficiency occurring within 3 months prior to screening or currently present;\n4. Subjects with acute diseases occurring from the screening phase to the first administration of the study drug that, in the investigator's judgment, may affect the study results;\n5. History of severe visual, ocular, or retinal diseases;\n6. Subjects with dysphagia;\n7. Subjects with known or suspected allergic reactions to the study drug or any of its excipients (as judged by the investigator); or subjects with clinically significant atopy or history of allergic diseases (as judged by the investigator);\n8. Subjects who have undergone surgery within 3 months prior to screening that, in the investigator's judgment, may affect drug absorption, distribution, metabolism, or excretion, or have severe surgical sequelae; or subjects planning to undergo surgery during the study;\n9. Subjects who have donated blood, lost a large amount of blood (≥ 400 mL), donated ≥ 2 units of component blood, or received blood transfusion within 3 months prior to the first administration of the study drug; or subjects planning to donate blood during the study;\n10. Subjects who have received any investigational drug or participated in any interventional clinical study within 3 months prior to the first administration of the study drug;\n11. Subjects who smoked an average of more than 5 cigarettes per day within 3 months prior to the first administration of the study drug, or cannot abstain from using any tobacco products during the study;\n12. Subjects who consumed an average of more than 14 units of alcohol per week within 3 months prior to the first administration of the study drug, or cannot abstain from using any alcohol-containing products during the study; or subjects with a positive breath alcohol test prior to study drug administration;\n13. Subjects who consumed excessive tea, coffee, and\u002For caffeinated beverages within 3 months prior to the first administration of the study drug, or cannot abstain from consuming tea, coffee, and\u002For caffeinated beverages during the study;\n14. Subjects who used any prescription drugs, over-the-counter drugs, Chinese patent medicines, Chinese herbal medicines, vitamins, or health food products within 28 days prior to screening or within 5 drug half-lives (whichever is shorter);\n15. Subjects whose 12-lead electrocardiogram (ECG) during the screening period meets any of the following criteria: 1) PR interval \\> 200 ms; 2) QTcF \\> 450 ms; 3) QRS duration \\> 110 ms; 4) QT interval \\> 500 ms; 5) Heart rate (HR) \\\u003C 50 bpm;\n16. Pregnant or lactating female subjects; or female subjects of childbearing potential (WOCBP) with a positive serum pregnancy test at any time prior to the first administration;\n17. Subjects with positive results or results exceeding the upper limit of the reference range in the eight infectious and immunological tests, which are deemed clinically significant by the investigator: hepatitis B virus (HBV) serology, hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV)-P24 antigen\u002Fantibody, and syphilis-specific antibody;\n18. Subjects with a positive urine drug screen or a history of drug abuse or drug use within 5 years prior to the study;\n19. Subjects who consumed or drank pitaya, mango, grapefruit, carambola, or foods\u002Fbeverages prepared from these fruits; or foods\u002Fbeverages containing xanthine, caffeine, or alcohol; or other special diets that may affect drug absorption, distribution, metabolism, or excretion within 72 hours prior to the first administration;\n20. Subjects with special dietary requirements, lactose intolerance, or inability to accept a unified diet;\n21. Subjects deemed unsuitable for participation in the study by the investigator.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},76,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study adopts a randomized, double-blind, parallel placebo-controlled dose-escalation design, consisting of two parts: Part 1 includes a single ascending dose (SAD) study plus a food effect (FE) study, and Part 2 is a multiple ascending dose (MAD) study.",[28],"Stargardt Disease","RECRUITING","2026-02-11",{"date":32,"type":33},"2026-02-18","ACTUAL",{"date":35,"type":33},"2026-01-01",{"date":37,"type":22},"2026-12-31",{"name":39,"class":40},"Heronova Pharmaceuticals","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100598407","phase-1-a-study-of-dc50292a-tablet-in-patients-with-mtap-deleted-advanced-or-metastatic-solid-tumors-100598407","NCT07071090","A Study of DC50292A Tablet in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors","An Open-Label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of DC50292A Tablet in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily signs the informed consent form, demonstrates understanding of the study, and is willing and able to comply with all trial procedures.\n2. Age ≥18 years, regardless of gender.\n3. Patients with histologically and\u002For cytologically confirmed solid tumors who are assessed by the investigator as having locally advanced, recurrent, or metastatic disease and have failed standard treatments at the current stage.\n4. At least one measurable lesion as per RECIST v1.1 criteria, assessed via imaging (tumor lesions located in previously irradiated areas or those having undergone other local-regional therapies are generally not considered measurable unless clear progression is confirmed by the investigator).\n5. MTAP deficiency, defined by one of the following: willingness to provide sufficient archived tumor tissue or fresh biopsy samples for MTAP testing; or documentation of MTAP homozygous deletion via NGS\u002FIHC or loss of MTAP protein expression in tissue; or availability of a prior NGS report (within 3 years) confirming MTAP homozygous deletion or an IHC report confirming loss of MTAP expression, as accepted by the investigator.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n7. Life expectancy ≥3 months.\n8. Absence of severe hematological, hepatic, renal, coagulation, or cardiac dysfunction.\n9. Male and female participants of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 3 months after the last dose of the study drug. Female participants of childbearing potential must have a negative serum pregnancy test result prior to the first dose of the study medication.\n\nExclusion Criteria:\n\n1. Received chemotherapy, radiotherapy, biologics, endocrine therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug, including: nitrosoureas or mitomycin C within 6 weeks prior; oral fluoropyrimidines or small-molecule targeted agents within 2 weeks or 5 half-lives (whichever is shorter); Chinese herbal medicines with antitumor indications within 2 weeks prior.\n2. Received any non-marketed investigational drugs or therapies within 4 weeks prior to the first dose.\n3. Undergone major organ surgery (excluding needle biopsy or surgery for pathologic fractures), significant trauma, or planned elective surgery during the trial within 4 weeks prior.\n4. Used CYP3A4-sensitive substrates, strong inhibitors\u002Finducers, CYP2C8-sensitive substrates, or P-gp inhibitors (see Appendix 3) within 14 days or 5 half-lives (whichever is shorter) prior.\n5. Previously treated with PRMT5 or MAT2A inhibitors.\n6. QTc interval ≥480 ms (mean of 3 measurements) on screening\u002Fbaseline 12-lead ECG.\n7. Prior allogeneic hematopoietic stem cell\u002Fbone marrow transplantation or solid organ transplantation, or current use of immunosuppressants\u002Fanti-rejection drugs.\n8. Known allergy to any active\u002Finactive ingredient of the study drug.\n9. Adverse reactions from prior antitumor therapy not resolved to CTCAE v5.0 Grade ≤1 (except non-risks like alopecia, Grade 2 peripheral neuropathy, or stable hypothyroidism on hormone replacement).\n10. Hepatitis B (HBsAg+ with HBV-DNA ≥2500 copies\u002FmL or 500 IU\u002FmL), HCV (HCV-RNA \\> lower limit of detection), HIV-positive, or syphilis (both specific\u002Fnon-specific antibodies positive).\n11. Symptomatic\u002Factive CNS metastases, leptomeningeal disease, or spinal cord compression. Asymptomatic CNS metastases may enroll if:\n\n    1. Measurable extracranial lesions per RECIST v1.1;\n    2. No new\u002Fprogressive CNS lesions for ≥4 weeks with stable neurologic symptoms;\n    3. No seizures\u002Fincreased intracranial pressure;\n    4. No steroids\u002Fantiepileptics\u002Fdehydrants for ≥2 weeks.\n12. Clinically significant third-space fluid accumulation (e.g., massive ascites\u002Fpleural effusion).\n13. Cardiovascular Disease: severe arrhythmias (e.g., ventricular arrhythmias requiring intervention, AV block II-III); ACS, CHF, aortic dissection, stroke, or Grade ≥3 cardiovascular events within 6 months; NYHA Class ≥II or high-risk structural heart disease; uncontrolled hypertension (SBP ≥150 mmHg and\u002For DBP ≥95 mmHg); QTc prolongation risks (e.g., heart failure, uncorrected hypokalemia, congenital\u002Ffamily history of long QT syndrome, concomitant QT-prolonging drugs).\n14. Systemic treatment for active infection within 4 weeks prior.\n15. Acute esophageal\u002FGI diseases affecting drug absorption (e.g., bowel obstruction, Crohn's disease, ulcerative colitis, short bowel syndrome).\n16. Pulmonary Disease: interstitial lung disease (ILD), pulmonary fibrosis, or drug-induced pneumonitis requiring treatment.\n17. Other Severe Conditions: hepatic, renal, neurologic\u002Fpsychiatric, endocrine, hematologic, or immune disorders compromising study participation.\n18. Other malignancies within 5 years (except cured malignancies like basal\u002F squamous cell skin cancer, low-risk prostate cancer, papillary thyroid cancer, or excised in situ cancers).\n19. Known alcohol\u002Fdrug dependence.\n20. Psychiatric disorders or poor adherence.\n21. Pregnant or breastfeeding women.\n22. Investigator's Discretion: any other clinical\u002Flaboratory abnormalities deemed unsuitable for the study.",{"count":50,"type":22},32,[25],"This study employs a non-randomized, open-label design to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of DC50292A tablets in patients with MTAP-deficient advanced or metastatic solid tumors. The study consists of two parts: dose escalation and dose expansion.",[54],"Solid Tumor Malignancies","2025-07-18",{"date":57,"type":33},"2025-07-23",{"date":59,"type":33},"2025-06-30",{"date":61,"type":22},"2028-01-01",{"name":39,"class":40},8,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":23,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100583225","phase-1-a-study-of-dc05f01-in-chinese-patients-with-recurrentrefractory-ovarian-cancer-and-other-advanced-solid-tumors-100583225","NCT06873555","A Study of DC05F01 in Chinese Patients with Recurrent\u002FRefractory Ovarian Cancer and Other Advanced Solid Tumors","Phase Ib\u002FIIa Multicenter, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of DC05F01 in Patients with Recurrent\u002FRefractory Ovarian Cancer and Other Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily signed the informed consent form, understanding the study and willing to follow and capable of completing all trial procedures.\n2. Aged ≥18 years, regardless of gender.\n3. Patients with locally advanced or metastatic disease, including:\n\n   Cohort 1: Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with FIGO stage III-IV, previously treated with platinum-based therapy and experienced disease progression or recurrence during or within 6 months (184 calendar days) after the last platinum-based treatment.\n\n   Cohort 2: Limited-stage small cell lung cancer patients, as staged by the Veterans Administration Lung Study Group (VALG), who are not surgical candidates and have not progressed during or after at least 4 cycles of platinum-based chemotherapy combined with concurrent or sequential radiotherapy, completed within 6 weeks before the first dose.\n\n   Cohort 3: Other solid tumors that have failed standard treatment, have no standard treatment options, or for whom standard treatment is not applicable at present.\n4. Cohort 1: Patients must have undergone initial or interval debulking surgery. Elevated CA125 alone without radiological or clinical evidence cannot be considered as disease progression or recurrence. Prior treatment may include bevacizumab and PARP inhibitors.\n\n   Cohort 2: Chemotherapy regimens must include platinum agents and intravenous etoposide, followed by a radical radiotherapy regimen. Prophylactic cranial irradiation is allowed based on the investigator's judgment and local standard of care, completed within 6 weeks before the first dose.\n5. According to RECIST 1.1 criteria, there must be at least one measurable lesion assessed by imaging (lesions within previously irradiated areas or treated with other local therapies are generally not considered measurable unless there is documented progression) (applicable to Cohort 1 and Cohort 3).\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n7. Expected survival time of ≥3 months.\n8. No significant hematologic, hepatic, renal, coagulation, or cardiac function abnormalities. Laboratory test results during the screening period (no transfusions or hematopoietic growth factor support within 14 days before testing) must meet the following standards:\n\n   Absolute Neutrophil Count (ANC) \\>1.5×10\\^9\u002FL. Hemoglobin (HGB) ≥90 g\u002FL. Platelets (PLT) \\>100×10\\^9\u002FL. Total Bilirubin (TBIL) ≤1.5 mg\u002FdL. Albumin (ALB): ≥3 g\u002FdL. Aspartate Aminotransferase (AST)\u002FAlanine Aminotransferase (ALT)\u002FAlkaline Phosphatase (ALP)\u002FGamma-Glutamyl Transferase (GGT) ≤2.5 times the upper limit of normal (ULN). If liver metastases are present, AST\u002FALT\u002FALP \\\u003C 5×ULN.\n\n   Serum Creatinine (Scr) ≤1.5×ULN or Creatinine Clearance (CrCl) ≥60 mL\u002Fmin. Prothrombin Time (PT)\u002FActivated Partial Thromboplastin Time (APTT) ≤1.5×ULN. Serum sodium, potassium, magnesium, calcium, and phosphate levels within normal range or deemed clinically insignificant by the investigator. Supplements to maintain normal electrolyte levels are permitted.\n9. Male subjects and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 3 months after the last dose of the study drug. Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of the study drug.\n\nExclusion Criteria:\n\n1. Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other anti-tumor treatments within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug, except for:\n\n   Nitrosoureas or mitomycin C within 6 weeks before the first dose. Oral fluorouracil or small-molecule targeted drugs within 2 weeks or 5 half-lives (whichever is shorter) before the first dose.\n\n   Anti-tumor traditional Chinese medicine within 2 weeks before the first dose.\n2. Received any other investigational drug or treatment in another clinical trial within 4 weeks before the first dose.\n3. Underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose, or requires elective surgery during the trial period.\n4. Used strong inhibitors or inducers of CYP3A4, CYP1A2, and\u002For CYP2D6 within 14 days or 5 half-lives (whichever is shorter) before the first dose.\n5. Previous allogeneic hematopoietic stem cell or bone marrow transplantation, or previous solid organ transplantation, or current use of immunosuppressive drugs or anti-rejection medications.\n6. Allergy to any active or inactive ingredient of the study drug.\n7. Adverse effects from prior anti-tumor treatments have not resolved to ≤Grade 1 according to CTCAE v5.0 (except for toxicities deemed not to pose a safety risk by the investigator, such as alopecia, Grade 2 peripheral neuropathy, or stable hypothyroidism managed with hormone replacement).\n8. Active hepatitis B (HBsAg positive with HBV-DNA \\> lower limit of detection at the study center); hepatitis C virus infection (HCV-RNA \\> lower limit of detection at the study center); positive HIV antibody test; positive Treponema pallidum antibody test.\n9. Presence of brain metastases or leptomeningeal metastases during the screening period or previously.\n10. Presence of uncontrolled third-space effusions (e.g., large pleural effusions and\u002For ascites) as judged by the investigator.\n11. Severe cardiovascular diseases, including but not limited to:\n\n    Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc.\n\n    Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher cardiovascular events within 6 months before the first dose.\n\n    New York Heart Association (NYHA) functional class ≥II, or other high-risk structural heart diseases as judged by the investigator.\n\n    Uncontrolled hypertension clinically (systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg after treatment).\n\n    Any factors increasing the risk of QTc prolongation or arrhythmias, such as heart failure, uncorrectable hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or use of any concomitant drugs known to prolong the QT interval.\n12. Presence of active infections requiring systemic treatment within 4 weeks before the first dose.\n13. Presence of gastrointestinal diseases affecting drug absorption, such as Crohn's disease, ulcerative colitis, or short bowel syndrome, in an acute exacerbation phase, which may affect the absorption, metabolism, or elimination of the study drug as judged by the investigator.\n14. Presence of interstitial lung disease, pulmonary fibrosis, or drug-induced interstitial pneumonia, except for radiation-induced pneumonia.\n15. Presence of other severe diseases, including liver disease, kidney disease, neurological\u002Fpsychiatric disorders, endocrine system diseases, hematologic diseases, immune system diseases, etc., that may affect participation in the study as judged by the investigator.\n16. Presence of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin, non-melanoma skin cancer, or in situ cervical cancer.\n17. Known alcohol or drug dependence.\n18. Presence of psychiatric disorders or poor compliance.\n19. Pregnant or breastfeeding women.\n20. Any other clinical or laboratory abnormalities or other reasons deemed by the investigator to make the subject unsuitable for participation in the study.",{"count":72,"type":22},60,[25,74],"PHASE2","This study is a multicenter, open-label, cohort expansion Phase Ib\u002FIIa trial designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profile of DC05F01 in patients with recurrent\u002Frefractory ovarian cancer and other advanced solid tumors.",[77,78,79],"Solid Tumors","Ovarian Cancer","Small Cell Lung Cancer","2025-03-16",{"date":82,"type":33},"2025-03-19",{"date":84,"type":33},"2024-09-11",{"date":86,"type":22},"2026-08",{"name":39,"class":40},2,""]