[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Biocity Biopharmaceutics 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,[8,43,64,87],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100629063","phase-1-bc3195-in-combination-with-pembrolizumab-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100629063",false,"NCT07469774","BC3195 in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase 1\u002F2, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Provide written informed consent.\n2. Aged at least 18 years at the time of ICF signature.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to the first dose of study treatment.\n4. Life expectancy of ≥ 3 months based on the Investigator's assessment.\n5. Participants in Dose escalation part must meet the following criteria: Histologically or cytologically confirmed advanced\u002Fmetastatic solid tumor by pathology report and have received, or been intolerant to, all treatment known to confer clinical benefit, including but not limited to: NSCLC, BC, HNSCC, ESCC, EMC, UC, CRC, OC, and prostate cancer. The sponsor or designee must approve eligibility for malignancies other than those specifically mentioned above.\n6. Participants in Dose expansion part must meet one of the following criteria:\n\n   1. For NSCLC (cohort 1):\n\n      Participants have pathologically documented Stage IIIB, IIIC, or Stage IV NSCLC without actionable genomic alterations (AGA) based on the American Joint Committee on Cancer, Eighth Edition (Participants must have documented negative test results for EGFR and ALK genomic alterations and have no known genomic alterations in ROS1, NTRK, BRAF, MET exon 14 skipping, or RET) and meet one of the following criteria:\n      1. Locally advanced or metastatic NSCLC participants relapsed or refractory to at least 1 prior line of therapy including platinum-based chemotherapy in combination with or without anti-PD(L)1 antibody; OR\n      2. Locally advanced or metastatic NSCLC participants relapsed or refractory to at least 2 prior lines of therapy including anti-PD(L)1 antibody and platinum-based chemotherapy sequentially.\n   2. For TNBC (cohort 2):\n\n      Participants have histologically or cytologically confirmed TNBC per ASCO\u002FCAP criteria based on the most recent analyzed biopsy or other pathology specimen and meets the following criteria: Relapsed or refractory to 2 or more prior systemic regimens for unresectable, locally advanced or metastatic disease (-For prior therapy, 1 could be in the (neo)adjuvant setting, provided progression occurred during treatment or within 12 months after treatment discontinuation;-Received taxane(s) in any setting).\n   3. For HNSCC (cohort 3):\n\n      Participants have histologically or cytologically confirmed locally advanced or metastatic HNSCC and meet one of the following criteria:\n      1. Relapsed or refractory to at least 1 prior line of therapy including platinum-based chemotherapy with cetuximab, or platinum-based chemotherapy with or without anti-PD(L)1 antibody. OR\n      2. Disease progression while on or after at least 2 prior lines of therapy including anti-PD(L)1 antibody and platinum-based chemotherapy sequentially.\n   4. For Other solid tumors (cohort 4):\n\n      Participants with other solid tumors and meets the following criteria:\n      1. Histologically or cytologically confirmed locally advanced or metastatic solid tumors (e.g., ESCC, EMC, UC, CRC, OC, prostate cancer or tumors with observed efficacy signal during the dose escalation part).\n      2. Participants refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n7. Participants with at least one measurable lesion according to RECIST v1.1 as assessed by the local site investigator\u002Fradiology.\n8. Participants with adequate organ function.\n9. Agree to provide previously archived tumor tissue samples, or newly obtained biopsy of a previously unirradiated tumor lesion (optional for dose escalation part). Formalin-fixed, paraffin-embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. Details pertaining to tumor tissue collection can be found in the Laboratory Manual.\n10. Males and females of child-bearing potential must agree to use effective contraception (e.g., oral contraceptives, intrauterine devices, abstinence, or barrier contraceptives combined with spermicides) from the time ICF signature until 6 months after the last dose. Females of childbearing potential include those who are premenopausal and those who are 2 years postmenopausal.\n\nExclusion Criteria:\n\n1. Has received prior systemic anticancer treatment, including investigational agents, within 5 half-lives or 4 weeks prior to the first dose of study treatment (whichever is shorter). Has received Traditional Chinese Medication within 7 days prior to study treatment.\n2. Participants who have received major surgery (defined as requiring general anesthesia and \\>24-hour inparticipant hospitalization) within 4 weeks prior to the first dose of study treatment. Participant must have recovered adequately from complications from the intervention prior to starting study treatment.\n3. Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis.\n\n   Note: Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n4. Has had an allogeneic tissue\u002Fsolid organ transplant.\n5. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.\n6. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study treatment.\n7. Has clinically uncontrolled pericardial effusion, pleural effusion, or ascites at screening.\n8. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease.\n9. Active viral infection requiring systemic therapy during the screening period.\n10. Hypertension that cannot be well-controlled with medical treatment. Not well-controlled is defined as systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>95 mmHg (adjustment of hypertensive medication prior to study initiation is permitted, but the mean of the most recent three consecutive blood pressure records prior to study entry must be ≤150\u002F95 mmHg \\[with at least 2- minute interval between each measurement\\]).\n11. Cardiovascular disease of clinical significance: Including New York Heart Association \\[NYHA\\] Class II-IV, congestive heart failure, second-degree or higher heart block, myocardial infarction within the past 3 months, unstable arrhythmia or unstable angina, marked QT interval prolongation (12-lead ECG showing baseline-corrected QTc interval \\>480 ms), cerebral infarction within 3 months, or having received PTCA or CABG within 6 months.\n12. Participants with active or chronic corneal disorders, with other active ocular conditions requiring ongoing therapy or with any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.\n13. Participants with any active infection that requires systemic anti-infective therapy judged by the investigators.\n14. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n    Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n15. Grade 2 or higher peripheral neuropathy. Other toxicities caused by prior anti-tumor therapy has not recovered to ≤ grade 1 (per CTCAE 5.0) (except for alopecia, pigmentation, and other events judged by the Investigator to be tolerable) or the level specified by the inclusion\u002Fexclusion criteria in this study.\n\n    Note: Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.\n16. Received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.\n17. Known severe hypersensitivity or delayed hypersensitivity (≥Grade 3) reactions to the same class and\u002For any components of BC3195 or pembrolizumab.\n18. Participants who received strong CYP3A4 inhibitors or strong CYP3A4 inducers within 14 days, before the first dose of the study treatment (refer to Appendix 7 for a list of strong CYP3A4 inhibitors and inducers).\n19. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention, or planned to receive live or live-attenuated vaccine during the screening. Administration of killed vaccines are allowed.\n20. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n21. Pregnant or breastfeeding or planning to become pregnant; a positive blood pregnancy test within 7 days prior to the first dose of study treatment.\n22. Participants with poor compliance, who are unwilling to or unable to follow study procedures.\n23. Has received radiation therapy to the lung that is \\>30 Gy within 6 months of the first dose of study treatment for participants with NSCLC.","ALL","18 Years",{"count":19,"type":20},111,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a Phase 1\u002F2, open-label, dose escalation and expansion study to assess the safety, pharmacokinetics, and preliminary efficacy of BC3195 in combination with pembrolizumab in participants with locally advanced or metastatic solid tumors.",[27],"Locally Advanced or Metastatic Solid Tumors",[29],"Solid Tumors","RECRUITING","2026-05-25",{"date":33,"type":34},"2026-05-28","ACTUAL",{"date":36,"type":34},"2026-03-31",{"date":38,"type":20},"2028-12-31",{"name":40,"class":41},"Biocity Biopharmaceutics 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":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":42},"100621273","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-pk-and-preliminary-efficacy-of-bc2027-in-patients-with-advanced-solid-malignancies-100621273","NCT07368478","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC2027 in Patients With Advanced Solid Malignancies","A Phase Ⅰa\u002FⅠb, Open-Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC2027 in Patients With Advanced Solid Malignancies","Inclusion Criteria:\n\n1. Provide written informed consent.\n2. Be at least 18 years old.\n3. Have an Eastern Cooperative Group (ECOG) performance status (PS) of 0 or 1.\n4. Have a life-expectancy of at least 3 months based on the Investigator's assessment.\n5. Patients with advanced solid tumors confirmed by histology or cytology, who have failed standard therapy, have no available standard therapy, or are intolerant to standard therapy.\n6. Phase 1a (dose escalation, Part 1)\n\n   a. Have an advanced solid malignancy confirmed by histologic or cytologic examination that is known to express GPC3 including, but not limited to, HCC, NSCLC (particularly squamous cell NSCLC), sarcoma (undifferentiated), ovarian clear cell adenocarcinoma (OCCC), esophageal squamous cell carcinoma (ESCC).\n7. Must provide either a previously archived tumor tissue sample or a fresh core or excisional biopsy from a site that was not irradiated. There must be at least 3-5 unstained sections. A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred to slides, and fresh biopsies are preferred over archival tissue. If archival tissue cannot be provided and a fresh biopsy cannot be obtained in Part 1, an exemption may be provided by the Sponsor.\n8. Must have adequate organ function within 7 days prior to the start of study treatment as defined below:\n\n   Hematological\\* ANC ≥1,500\u002FμL or ≥1.5×109\u002FL Platelets ≥100,000\u002FμL or ≥100×109\u002FL (For HCC patients, PLTs ≥75×109\u002FL) Hemoglobin ≥9.0 g\u002FdL Kidney Function Creatinine clearance (CrCl)\\*\\* ≥50 mL\u002Fmin Liver Function Total Bilirubin (TBIL) ≤1.5×ULN, or direct bilirubin ≤ULN (patients with total bilirubin level \\>1.5×ULN).\n\n   AST (SGOT) and ALT (SGPT) ≤2.5×ULN (≤5×ULN in patients with liver metastases) Coagulation International Normalized Ratio (INR), Prothrombin Time (PT), and activated partial thromboplastin time (aPTT) :INR≤1.5; PT and aPTT ≤1.5×ULN or within a therapeutic range if on an anticoagulant.\n\n   \\* Blood transfusion or growth factor support is not allowed within 14 days prior to blood sampling.\n\n   \\*\\* CrCl should be calculated according to institutional standards.\n9. Must have at least one measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (In the dose escalation part of the study (Part 1), patients without measurable lesions may be enrolled if they have evaluable disease and are approved by the sponsor). Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n10. Must agree to use highly effective contraceptive measures if patient is a man or woman of childbearing potential. Highly effective contraceptive measures include measures like hormonal contraceptives, intrauterine devices, vasectomy, or tubal ligation, and others (Section 5.3), from the time of signing the informed consent until 6 months after the last dose of the study drug. Women of childbearing potential (WCBP) must have a negative blood or urine pregnancy test within 7 days prior to the first dose of study drug. Female patients with surgically sterile or are postmenopausal for at least 12 months without an alternative medical cause are also allowed.\n\nAdditional Inclusion Criteria for Part 2\n\nIn addition to fulfilling the inclusion for Part 1, patients enrolling in cohorts in Part 2\u002FPhase Ib must have:\n\n1. Cohort 1 (NSCLC Cohort)\n\n   1. Positive expression of GPC3 confirmed by immunohistochemistry (IHC) assay, or with existing prior IHC test report documenting GPC3 positivity.\n   2. Patients with non-small cell lung cancer (NSCLC) who have failed no more than 3 prior lines of systemic antineoplastic therapy.\n2. Cohort 2 (HCC Cohort)\n\n   1. IHC evidence of GPC3 expression on archival tumor or a fresh biopsy unless biopsy is not feasible or safe and with approval of the Sponsor.\n   2. The subject has received treatment with 1 prior regimen in the first line advanced setting consisting of an appropriate monoclonal antibody (mAb) targeting PD-1 or PD-L1 with an appropriate mAb targeting CTLA-4 and\u002For an appropriate tyrosine kinase inhibitor (TKI) or mAb targeting vascular endothelial growth factor (VEGF, e.g., bevacizumab). The subject must have progressed, demonstrated intolerance, or refused such treatment. If a subject had refused treatment, the reasons for such must be documented in the records and case report form (CRF).\n   3. The patient must have Barcelona Clinic Liver Cancer (BCLC) stage B or C HCC (See Appendix 1), not amenable to locoregional therapy or refractory to locoregional therapy likely to result in reasonable clinical benefit, and not amenable to a curative treatment approach.\n   4. The subject has a Child-Pugh A score (See Appendix 2) within 7 days of study drug treatment.\n3. Cohort 3 (Advanced GPC3 expressing solid cancer).\n\n   1. GPC3 positivity confirmed by IHC assay, or documented in prior IHC reports.\n   2. Patients excluding Cohort 1 and Cohort 2 with failure of ≤ 2 prior lines of systemic antineoplastic therapy.\n\nExclusion Criteria:\n\nPatients who meet any of the exclusion criteria must not be enrolled in the study.\n\n1. Prior treatment with GPC3-targeted ADC.\n2. Prior treatment with systemic anticancer treatment, including investigational agents, within a period that is less than five half-lives or 2 weeks before the start of treatment, whichever is shorter.\n3. Known hypersensitivity or delayed hypersensitivity reactions to the same class and\u002For any component of BC2027.\n4. Treatment with strong CYP3A4 inhibitors or inducers, and P-gp inhibitors within 14 days or 5 half-lives whichever is shorter, before the first dose.\n5. For patients with advanced NSCLC:\n\n   a. Positive for driver oncogenes: including EGFR mutation, ALK gene fusion, ROS1 gene fusion, KRAS-G12C mutation, c-MET (exon 14 skipping, MET amplification and overexpression), HER2 mutation, RET gene fusion, etc.\n\n   For HCC patients:\n   1. Received local hepatic therapy including, but not limited to, surgery, radiotherapy, hepatic arterial embolization (TAE), hepatic arterial chemoembolization (TACE), hepatic arterial perfusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within 4 weeks prior to initiation of the study drug.\n   2. History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy (eg, no lactulose, rifaximin, etc if used for purposes of hepatic encephalopathy)\n   3. The patient has main portal vein thrombosis ((i.e. thrombosis in the main trunk of the portal vein, with or without blood flow) on baseline imaging.)\n   4. Documented gastrointestinal bleeding within past 6 months or at high risk of gastrointestinal bleeding per investigator's clinical judgement, due to esophageal varices, active gastric or duodenal ulcers.\n6. Active and severe viral infections meeting the following criteria:\n\n   1. Known HIV seropositivity.\n   2. Known active hepatitis B (Screening for hepatitis B is not required for non-HCC patients):\n\n      * For HCC patients: HBV DNA \\> 2000 IU\u002FmL. (For patients with positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibodies (anti-HBcAb) with detectable HBV DNA (≥10 IU\u002FmL)\\], patients with the following conditions may be enrolled: patients who have received antiviral therapy and had sufficient suppression of viral replication before enrollment (HBV DNA ≤ 2000 IU\u002Fml), and patients must continue to receive antiviral therapy during the study and for 6 months after the last dose.)\n      * For other solid malignancies patients: HBsAg positive and HBV-DNA titer \\> 500 IU\u002FmL or \\> 2500 copies\u002FmL.\n   3. Known active hepatitis C :\n\n      * For HCC patients: Co-infection of HBV and HCV. (The following conditions are allowed for inclusion: positive HCV RNA test or positive HCV antibody, and patients complying with local medical practice for treatment.)\n7. Severe immunodeficiency requiring systemic corticosteroid therapy at a prednisone-equivalent dose (\\>10 mg\u002Fday), or any other systemic immunosuppressive therapy, unless approved by the sponsor.\n8. A history of allogeneic tissue or solid organ transplantation.\n9. A history of radiation pneumonitis, or receipt of radiotherapy within 2 weeks prior to the initiation of study treatment.\n\n   Note: Patients must have recovered from radiation-related toxicities and must not be receiving corticosteroid treatment. A 1-week washout period is permitted for palliative radiotherapy (≤ 2 weeks of radiotherapy) for non-central nervous system (non-CNS) diseases.\n10. Unstable central nervous system (CNS) metastases and\u002For carcinomatous meningitis. For patients with previously treated brain metastases who have achieved radiological stability (i.e., no evidence of disease progression on repeated imaging examinations for at least 4 weeks, as documented in imaging obtained during screening; and no requirement for corticosteroid treatment for at least 14 days prior to the first dose), routine brain imaging is not required during screening.\n11. Uncontrolled pleural effusion, ascites, or pericardial effusion at the time of screening.\n12. A history of interstitial lung disease (ILD) or drug-related interstitial lung disease, or any evidence of clinically active interstitial lung disease.\n13. Clinically significant cardiovascular disease, including but not limited to:\n\n    * Congestive heart failure (CHF) of New York Heart Association (NYHA) functional class III or higher, or left ventricular ejection fraction (LVEF) \\\u003C 50%.\n    * Unstable angina pectoris or myocardial infarction occurring within 6 months prior to enrollment.\n    * Severe cardiac arrhythmias, including but not limited to complete left bundle branch block, atrioventricular block of second degree or higher, and ventricular tachycardia (including frequent ventricular premature beats).\n    * Clinically uncontrolled hypertension, defined as systolic blood pressure (SBP) ≥ 160 mmHg and\u002For diastolic blood pressure (DBP) ≥ 100 mmHg despite anti-hypertensive medication use.\n14. Clinically significant electrocardiogram (ECG) abnormalities, including any of the following:\n\n    * Markedly prolonged QT\u002FQTc interval on screening ECG (i.e., repeated measurements demonstrating a QTc interval \\> 470 ms) (QTcF calculated based on the Fridericia formula).\n    * A history of risk factors for torsades de pointes, such as congestive heart failure, hypokalemia, family history of long QT syndrome, and other risk factors.\n15. Grade ≥ 2 peripheral neurotoxicity or neuropathy, and other toxicities caused by prior anti-tumor therapy that have not resolved to Grade ≤ 1 (per CTCAE Version 5.0). Exceptions include alopecia, skin hyperpigmentation, other events deemed tolerable by the investigator, or specific-grade toxicities specified in the inclusion\u002Fexclusion criteria of this study.\n16. Patients with active or chronic corneal disease, other active ophthalmic diseases requiring continuous treatment, or any clinically significant corneal disease that prevents adequate monitoring for drug-induced keratopathy.\n17. Active infections requiring systemic anti-infective therapy.\n18. Poor patient compliance, or unwillingness or inability to follow the procedures specified in the study protocol.",{"count":51,"type":20},180,[23],"This is a phase Ia\u002FIb, open-label, dose escalation and dose expansion study designed to evaluate the safety, tolerability, PK, and preliminary anticancer activity of BC2027 in patients with advanced solid Malignanciesr",[55],"Advanced Solid Malignancies","2026-01-21",{"date":58,"type":34},"2026-01-26",{"date":60,"type":34},"2025-11-24",{"date":62,"type":20},"2028-06",{"name":40,"class":41},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":86,"locationsCount":42},"100579094","phase-3-a-study-of-sc0062-capsule-for-the-treatment-of-iga-nephropathy-with-proteinuria-100579094","NCT06819826","A Study of SC0062 Capsule for the Treatment of IgA Nephropathy with Proteinuria","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SC0062 Capsule in Patients with IgA Nephropathy and Proteinuria (SUCCESS-1)","Inclusion Criteria:\n\n* Voluntarily sign informed consent and fully understand and comply with trial procedures;\n* Age ≥18 years old, gender unlimited;\n* IgA nephropathy patients with proteinuria must meet all of the following conditions:\n\n  1. According to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI, 2009) creatinine equation, after 12 weeks of the stable use of the background therapy, the mean of two estimated glomerular filtration rates (eGFR) calculated from central laboratory results was ≥ 30 and \\\u003C 90 mL\u002Fmin\u002F1.73m2.\n  2. Received the maximum labeled or tolerated dose of RAASi (ACEI or ARB) for at least 12 weeks before randomization; If subjects were treated with SGLT2i, MRA, or GLP-1RA prior to randomization, the stable use was also required for at least 12 weeks (maximum tolerated and optimal dose determined by the investigator; Subjects who are intolerant to RAASi may also be enrolled).\n  3. The pathological examination confirmed IgA nephropathy. Two 24-hour urine samples were collected during the screening period, after 12 weeks of the stable use of the background treatment. Both of the results conducted by the central laboratory were met: 24-hour urine protein to creatinine ratio (UPCR) ≥ 0.75 g\u002Fg or 24-hour urinary protein excretion rate (UPER) ≥ 1.0 g.\n* Laboratory tests shall meet the following criteria:\n\n  1. Serum albumin ≥ 30 g\u002FL;\n  2. Hemoglobin ≥ 90 g\u002FL ; Platelet count ≥80×109\u002FL;\n  3. Brain natriuretic peptide (BNP) ≤ 200 pg\u002FmL or N-terminal pro B-type natriuretic peptide (NT-proBNP) ≤ 600 pg\u002FmL;\n  4. Blood potassium ≤ 5.5 mmol\u002FL;\n  5. Systolic blood pressure (SBP) ≤ 160 mmHg;\n  6. Hemoglobin A1c ≤ 8%;\n  7. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2×ULN; Total bilirubin ≤ 1.5×ULN;\n* During the entire study period from the signing of the informed consent to 3 months after the final administration, fertile females and males who have not received vasectomy should take effective contraceptive measures \\[Effective contraceptive measures include: Vasectomy, intrauterine device (IUD), hormones (oral, patch, ring, injection, implant) and barrier methods (diaphragm, cervical cap, sponge, condom).\n\nExclusion Criteria:\n\n* Pregnant or lactating females; Women of childbearing potential (WOCBP) who have a positive blood pregnancy test before randomization;\n* A history of hypersensitivity or allergic to any component of the study drug (SC0062 capsule);\n* Systemic use of corticosteroids or immunosuppressants for more than 2 weeks within 3 months prior to randomization; The following are excluded: local topical or intraarticular, intranasal and inhaled glucocorticoids; Use of biological agents (such as rituximab, Telitacicept, etc.), Iptacopan capsules, budesonide enteric-coated capsules within 6 months prior to randomization;\n* Concurrent diagnosis of chronic kidney disease caused by other etiologies (including polycystic kidney disease, diabetic kidney disease, or other primary glomerular disease) as determined by the investigator;\n* Secondary IgA nephropathy, including but not limited to: Henoch-Schönlein purpura, ankylosing spondylitis, systemic lupus erythematosus, amyloidosis, etc.\n* Renal biopsy results showed that \\> 25% of glomeruli with crescents, or interstitial fibrosis\u002Ftubular atrophy \\> 50%;\n* Based on KDIGO guidelines, rapidly progressive glomerulonephritis was clinically suspected (judged by the investigator);\n* Nephrotic syndrome (UPER \\> 3.5g\u002Fd and serum albumin \\\u003C 30g\u002FL, with or without edema and hyperlipidemia) at screening;\n* A history of any lung disease requiring oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema, pulmonary edema, etc.);\n* Use of the same class drug (endothelin receptor antagonist, ERA) before randomization;\n* A history of moderate or severe edema, non-traumatic facial edema, or myxedema within the 6 months prior to randomization;\n* A history of orthostatic hypotension within 6 months before randomization;\n* A history of clinically significant cirrhosis assessed by the investigator;\n* A history of worsening heart failure, acute coronary syndrome, transient ischemic attack, stroke and other serious cardiovascular and cerebrovascular diseases within 6 months prior to randomization, or NYHA Grade III to IV at screening;\n* A history of kidney or other organ transplantation (except corneal transplantation);\n* A condition which had the potential to interfere with oral drug absorption, such as subtotal gastrectomy, clinically severe gastrointestinal disorders, or certain types of bariatric surgery;\n* Use of potent CYP3A4 inducers and potent CYP3A4 inhibitors within 2 weeks (14 days) before randomization;\n* Received other treatment for IgA nephropathy within 28 days prior to randomization except as permitted by the protocol;\n* Active Hepatitis B, active Hepatitis C, active syphilis and Hiv-positive ;\n* A history of malignant tumors within 5 years, except for skin squamous cell carcinoma, colon polyp or in situ cervical cancer, thyroid papillary carcinoma;\n* A history of alcohol or drug abuse or dependence, or a history of mental illness;\n* Participated in clinical trials of other investigational drugs or medical devices within 3 months prior to randomization;\n* Any other clinically significant disease, condition, or medical history that may interfere with subjects' safety, study evaluation, and\u002For study procedures at the discretion of the investigator;\n* Any other reasons for not being suitable for participating in this clinical study at the discretion of the investigator.",{"count":72,"type":20},360,[74],"PHASE3","This is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of SC0062 capsule compared to placebo in patients with IgA nephropathy in the presence of proteinuria. The participants must have a high risk of disease progression, despite of stable use of the maximum tolerated labelled or optimized dose of RAASi and\u002For SGLT2i for at least 12 weeks prior to randomization.",[77],"IgA Nephropathy (IgAN)",[79],"Endothelin Type A Receptor Antagonist","2025-02-13",{"date":82,"type":34},"2025-02-17",{"date":84,"type":20},"2025-02-14",{"date":38,"type":20},{"name":40,"class":41},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":42},"100558250","phase-1-a-study-to-assess-the-safety-pharmacokinetics-and-antitumor-activity-of-bc3195-in-patients-with-advanced-or-metastatic-cancer-100558250","NCT06548672","A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of BC3195 in Patients With Advanced or Metastatic Cancer","A Phase Ia\u002FIb, Open-Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years of age.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n3. Subjects with locally advanced or metastatic solid tumors confirmed by histology or cytology who have not benefitted from or are intolerant of available therapy(ies) associated with a reasonable likelihood to confer clinical benefit because of known CDH3 expression, including, albeit not limited to: HNSCC, ESCC, BC, NSCLC, EC, UC, CRC, OC, pancreatic cancer, and prostate cancer.\n4. Agree to provide previously archived tumor tissue samples, or newly obtained core biopsy, or excisional biopsy of a previously unirradiated tumor lesion (formalin fixed, paraffin embedded tissue blocks)\n5. Subjects with at least one measurable lesion according to RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions\n6. Life expectancy ≥ 3 months\n7. Subjects with adequate organ function\n8. Men or women of childbearing potential must use a highly effective method of contraception during the study and continue to take contraception measures for 6 months after the last dose of the study drug.\n9. Patients voluntarily participate in the study and should provide a written informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Prior systemic anticancer treatment, including investigational agents, within 5 half-lives or 4 weeks before the first dose (whichever is shorter)\n3. Subjects diagnosed with immunodeficiency within 7 days prior to the first dose of the study drug; or subjects who are receiving longterm systemic steroid therapy or any other form of immunosuppressive therapy\n4. Previously received allogeneic tissue\u002Fsolid organ transplantation\n5. Patients who have received radiation therapy within 2 weeks prior to the start of study treatment or with a history of radiation pneumonitis.\n6. Known active CNS metastases and\u002For cancerous meningitis. Subjects with previously treated brain metastases who meet the following conditions are permitted to participate in the study: radiologically stable, that is, repeat imaging shows no evidence of progression for at least 4 weeks, clinically stable, and no steroid therapy is required for at least 14 days prior to the first dose of study treatment\n7. Active viral infection requiring systemic therapy during the screening period\n8. Clinically uncontrolled pericardial effusion, pleural effusion, or ascites at screening\n9. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease\n10. Hypertension that cannot be well-controlled with medical treatment. Not well-controlled is defined as systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>90 mmHg (adjustment of hypertensive medication prior to study initiation is permitted, but the mean of the most recent three consecutive blood pressure records prior to study entry must be ≤150\u002F90 mmHg \\[with at least 2- minute interval between each measurement\\])\n11. Cardiovascular disease of clinical significance: Including New York Heart Association \\[NYHA\\] Class II-IV, congestive heart failure, second-degree or higher heart block, myocardial infarction within the past 3 months, unstable arrhythmia or unstable angina, marked QT interval prolongation (12-lead ECG showing baseline-corrected QTc interval \\>480 ms), cerebral infarction within 3 months, or having received PTCA or CABG within 6 months\n12. Subjects with active or chronic corneal disorders, with other active ocular conditions requiring ongoing therapy or with any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy\n13. Grade 2 or higher peripheral neuropathy. Other toxicities caused by prior anti-tumor therapy has not recovered to ≤ grade 1 (per CTCAE 5.0) (except for alopecia, pigmentation, and other events judged by the Investigator to be tolerable) or the level specified by the inclusion\u002Fexclusion criteria in this study\n14. Subjects with any active infection that requires anti-infective therapy judged by the investigators\n15. Known hypersensitivity or delayed hypersensitivity reactions to the same class and\u002For any components of BC3195\n16. Subjects who received strong CYP3A4 inhibitors and Strong CYP3A4 inducers within 14 days or 5 half-lives whichever is shorter, before the first dose (refer to Appendix 7 for a list of strong CYP3A4 inhibitors and inducers)\n17. Subjects are not suitable for participating the study judged by the investigators\n18. Subjects with poor compliance, who are unwilling to or unable to follow study procedures",{"count":95,"type":20},148,[23],"This is a phase Ia\u002FIb, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of BC3195 in subjects with locally advanced or metastatic solid tumors in whom standard treatment has failed (either due to disease progression or intolerance). This study will consist of two parts: Dose escalation (Part 1) and dose expansion (Part 2). Each part will include a screening period, a treatment period, and follow-up period.",[99,100],"Advanced Cancer","Metastatic Solid Tumor","2024-08-09",{"date":103,"type":34},"2024-08-12",{"date":105,"type":34},"2024-06-24",{"date":107,"type":20},"2027-06-30",{"name":40,"class":41},""]