[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kyowa Kirin Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":258},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,42,63,86,108,130,157,190,216,238],{"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},"100579411","phase-1-study-of-kk3910-in-healthy-volunteers-and-patients-with-essential-hypertension-100579411",false,"NCT06823947","Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension","A Phase 1, Placebo-Controlled, Double-Blind, Randomized, Single and Multiple Ascending-Dose Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension","Inclusion Criteria: Part 1\n\n* Voluntary consent to participate in this study must be given (in writing)\n* Japanese healthy adults or non-Asian healthy men 18 to \\\u003C 55 years at the time of informed consent ( Japanese healthy adults 65 to \\\u003C 80 years for the elderly cohort)\n* BMI is within the specified range at screening\n\nInclusion Criteria: Part 2\n\n* Voluntary consent to participate in this study must be given (in writing)\n* Japanese patients with essential hypertension, aged 18 to \\\u003C65 years at the time of informed consent\n* BMI is within the specified range at screening\n\nInclusion Criteria: Part 3\n\n* Voluntary consent to participate in this study must be given (in writing)\n* Japanese patients with essential hypertension, aged 18 to \\\u003C80 years at the time of informed consent\n* BMI is within the specified range at screening\n\nExclusion Criteria: Part 1\n\n* History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.\n* History of or current drug allergy\n* History of or current alcoholism or drug addiction\n* Smoking within the specified period\n* infection within the specified period\n* Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study\n\nExclusion Criteria: Part 2\n\n* History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.\n* History or of current drug allergy\n* History of or current alcoholism or drug addiction\n* Pregnant or breastfeeding patients, or patients willing to have a child during the study\n* Smoking within the specified period\n* infection within the specified period\n* Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study\n\nExclusion Criteria: Part 3\n\n* History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.\n* History or of current drug allergy\n* History of or current alcoholism or drug addiction\n* Pregnant or breastfeeding patients, or patients willing to have a child during the study\n* Smoking within the specified period\n* infection within the specified period\n* Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study",true,"ALL","18 Years","80 Years",{"count":21,"type":22},160,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Part 1 : To evaluate the safety of single-dose KK3910 in healthy volunteers. Part 2 : To evaluate the safety of multiple-dose KK3910 in patients with essential hypertension. Part 3 : To assess the safety profile of repeated dosing of KK3910 in an additional hypertension cohort.",[28],"Healthy Volunteers Essential Hypertension","RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":33},"2025-04-03",{"date":37,"type":22},"2027-12",{"name":39,"class":40},"Kyowa Kirin Co., Ltd.","INDUSTRY",3,{"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":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100578500","phase-1-phase-i-clinical-trial-of-kk2845-in-patients-with-relapsed-or-refractory-acute-myeloid-leukemia-and-other-hematologic-malignancies-100578500","NCT06812104","Phase I Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Other Hematologic Malignancies.","A Phase I, Multicenter, Non-controlled, Open-label, Non-randomized, Dose-escalation Study of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Other Hematologic Malignancies.","Inclusion Criteria:\n\n【Patients with Relapsed or Refractory Acute Myeloid Leukemia】\n\n1. Patients with a confirmed diagnosis of AML according to the WHO classification (2022 edition)by pathological examination at the performing institution conducted as screening test.\n2. Patients who meet the following definition of relapsed or refractory.\n\n   Relapse: Patients with any of the following relapse findings after achieving CR, CRh, or CRi.\n   * Myeloblasts \\>5%\n   * Blood blasts reappear in two peripheral blood samples at least one week apart\n\n   Refractory: Patients who have failed to achieve CR, CRh, or CRi after a sufficient duration of initial intense chemotherapy or initial treatment with venetoclax or hypomethylating agent.\n3. Patients who are considered to have no standard treatment with sustained remission, who have failed to complete a potentially curative treatment, who have no treatment with a promising therapeutic effect, or who have refused standard treatment.\n\n【Patients with other Hematologic Malignancies】 1. Patients diagnosed with each type of Hematologic Malignancies.\n\n【Other criteria common to all eligible patients】\n\n1. Patients who have given their free and voluntary written consent to participate in this clinical trial.\n2. Patients must be at least 18 years of age at the time consent is obtained.\n3. Patients with an ECOG PS of 0 to 2 on screening test.\n4. Patients with hematopoietic, hepatic, renal, and cardiac function that meet all of the following criteria on screening test.\n\n   * Hematopoietic capacity\n\n     * Neutrophil count greater than 500\u002Fmm3 However, even if the neutrophil count is less than 500\u002Fmm3, if the principal investigator or sub investigator judges that the neutrophil count is expected to improve, enrollment in this study is acceptable.\n   * Liver function\n\n     * AST within 3.0 times the upper reference limit\n     * ALT within 3.0 times the upper reference limit\n     * T-Bil within 1.5 times the upper limit of the standard\n   * Kidney function\n\n     * Creatinine clearance (Cockcroft-gault formula) equal to or greater than 50 mL\u002Fmin\n\n   However, even if the creatinine clearance calculated using the above formula is less than 50 mL\u002Fmin, if the value is equal to or greater than 30 mL\u002Fmin and the serum creatinine level is within 1.5 times the upper limit of the standard value, enrollment in this study is acceptable\n\n   ・Cardiac function\n   * LVEF of 50% or more (MUGA or ECHO)\n   * QTcF \\\u003C 450 msec for males and \\\u003C 480 msec for females\n5. Patients who are expected to survive longer than 3 months.\n\nExclusion Criteria:\n\n1. Patients who are diagnosed with APL.\n2. Patients with suspected extramedullary disease.\n3. Patients with a history of malignancy other than those listed in the inclusion criteria or with active malignancy other than those listed in the inclusion criteria (resected localized basal cell carcinoma and localized squamous cell carcinoma of the skin, resected noninvasive cervical cancer, resected noninvasive breast cancer, and cancers for which the last curative treatment was given more than 5 years ago are eligible for enrollment).\n4. Patients with white blood cell count greater than 25000\u002Fmm3 (If treatment with hydroxyurea results in a white blood cell count of 25000\u002Fmm3 or less, enrollment in this study is acceptable) on screening test.\n5. Patients who underwent a previous allogeneic hematopoietic stem cell transplant.\n\n   However, enrollment in this trial is permitted if all of the following criteria are met:\n   * At least 6 months have elapsed since allogeneic hematopoietic stem cell transplantation as of Cycle 1 Day 1.\n   * The patient does not have active acute GvHD of Grade 2 or higher, nor active chronic GvHD of any severity. Acute GvHD is classified according to the MAGIC criteria (Harris et al., 2016), and chronic GvHD is classified according to the NIH criteria (Jagasia et al., 2015), by Grade or severity. Acute GvHD should be graded according to the MAGIC criteria (Harris et al., 2016), and chronic GvHD according to the NIH criteria (Jagasia et al., 2015).\n   * At least 4 weeks have elapsed since the donor lymphocyte infusion at Cycle 1 Day 1.\n6. Patients who have received anti-tumor therapy such as anticancer agents or radiotherapy (except for patients taking hormone therapy as adjuvant maintenance therapy for breast or prostate cancer prior to the start of study treatment) within the following time periods prior to Cycle 1 Day 1.\n\n   * anticancer agents: 2 weeks (If hydroxyurea is used to control blasts, registration is acceptable for use up to Day -1)\n   * Hormone therapy: 2 weeks\n   * Radiation therapy: 4 weeks\n   * Unapproved medical devices: 4 weeks\n7. Patients who received another investigational drug within 4 weeks or 5 times the half-life prior to Cycle 1 Day 1, whichever is shorter.\n8. Patients who underwent major surgery (excluding biopsy, central venous catheter insertion, and tooth extractions, etc.) within 4 weeks prior to Cycle 1 Day 1.\n9. Patients who received a live vaccine within 4 weeks prior to Cycle 1 Day 1.\n10. Patients who have not recovered to Grade 1 or below from an adverse event caused by previously administered anti-tumor therapy.\n\n    However, patients with alopecia or laboratory abnormalities within the range described in the selection criteria or patients experiencing Grade 2 chronic adverse events may be enrolled in this study if the investigator or subinvestigator determines that the safety evaluation of the subject will not be affected.\n11. Patients with the following infections.\n\n    * Required systemic treatment (including bacterial, viral, and fungal pathogens)\n    * Difficulty for initiating anti-tumor therapy However, patients with infections controlled by antibiotic or antiviral therapy, or patients receiving prophylactic antibiotic or antiviral therapy, may be enrolled in this study.\n12. Patients who are suspected SARS-CoV-2 infection (e.g., patients with mild infectious findings and a positive SARS-CoV-2 test without subsequent documentation of a negative test result, patients suspected of ongoing infection based on clinical characteristics).\n13. Patients with active interstitial lung disease (including drug-induced pneumonia) or a history of such disease.\n14. Patients who have received continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs within 4 weeks prior to Cycle 1 Day 1.\n\n    However, topical, inhalation use, and low-dose corticosteroids (equivalent to 10 mg\u002Fday of prednisolone) is acceptable for enrollment in this study.\n15. Patients with a history of clinically severe cardiovascular disease (e.g., complete left bundle branch block, uncontrolled ventricular fibrillation, uncontrolled ventricular arrhythmia, angina pectoris, myocardial infarction, prolonged QT syndrome, NYHA grade III or IV congestive heart failure) within 6 months prior to screening test.\n16. Patients with a history of arterial thrombosis (e.g., stroke, pulmonary embolism) within 6 months prior to the screening test.\n17. Patients with positive for HBV antigen or antibody, HCV antibody, HIV antibody, or HTLV-1 antibody at screening test. However, the following cases are acceptable for enrollment in this clinical trial.\n\n    * HBV test at screening test is negative for HBs antigen and positive for either HBc or HBs antibody or both, but HBV-DNA test is below the lower limit of quantification or below 20 IU\u002FmL (1.3 LogIU\u002FmL).\n    * Clear history of hepatitis B vaccination and positive HBs antibody alone.\n    * Negative HCV nucleic acid amplification test (HCV-RNA test) with positive HCV antibody test at screening test.\n18. Patients with acquired, unclassifiable or hereditary, primary, or secondary immunodeficiency.\n19. Patients with a history of Grade 3 or higher allergic reactions to antibody drugs, payloads, or excipients to KK2845.\n20. Patients who are pregnant, lactating (excluded from this study even if lactation is interrupted), potentially pregnant, or wishing to become pregnant during this study period.\n21. Patients with psychiatric disorders, central nervous system illnesses (e.g., encephalopathy), or social conditions that are judged to make compliance with the clinical trial difficult or affect obtaining written consent.\n22. Other patients who are considered to be undesirable to participate in this study by investigator or subinvestigator.",{"count":50,"type":22},156,[25],"This is the first in human study of KK2845. This clinical trial consists of Part 1 (Dose Escalation) and Part 2 (Backfill).\n\nFor patients with relapsed or refractory acute myeloid leukemia (AML) and other Hematologic Malignancies, in Part 1, the tolerability of KK2845 will be evaluated to determine the maximum tolerated dose (MTD). In Part 2, additional data will be collected by administering KK2845 at dose levels for which tolerability has been confirmed.",[54],"Relapsed or Refractory AML and Other Hematologic Malignancies","2026-06-29",{"date":32,"type":33},{"date":58,"type":33},"2024-10-10",{"date":60,"type":22},"2031-11-30",{"name":39,"class":40},17,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100638130","phase-1-a-phase-12-study-of-kk2430-in-participants-with-hematologic-neoplasms-100638130","NCT07629726","A Phase 1\u002F2 Study of KK2430 in Participants With Hematologic Neoplasms","A Phase 1\u002F2, Multicenter, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KK2430 in Participants With Hematologic Neoplasms","Inclusion Criteria:\n\n* Participants must be at least 18 years of age at the time of signing the informed consent.\n* At least 1 measurable diseases based on CT scan or MRI\n* Renal function values\n* Participants who have an ECOG PS score of 0, 1 or 2.\n* Be willing to provide a fresh tissue taken at current relapse at screening period.\n* Meet laboratory values at Screening i.e., ANC, Platelets, Corrected serum calcium, AST and ALT, Total bilirubin etc\n* Contraceptive use by \\[men and women\\] should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Women of childbearing potential and fertile men must agree to use highly effective contraceptive methods • At least 1 measurable diseases based on CT scan or MRI\n* Capable of giving signed informed consent\n* Health Information Access: Capable of providing access to personal health information via HIPAA authorization (US only).\n* Legal Status: Not under any administrative or legal supervision or institutionalization due to regulatory or juridical order.\n\nExclusion Criteria:\n\n* Medical Conditions\n* History of prior allogenic transplant.\n* Presence of Grade 2 peripheral neuropathy with pain.\n* Impaired cardiac function or clinically significant cardiac disease at Screening\n* Known active CNS involvement or clinical signs of meningeal involvement.\n* Evidence of HIV infection.\n* Active chronic HBV\u002FHCV infection,\n* Participants with positive anti-HBc must have a negative HBV-DNA quantification test result to be enrolled.\n* Receipt of any anti-tumor therapy within three weeks or at least five half-lives prior to the Screening visit, whichever is shorter.\n* Toxicities from prior anticancer therapies that have not resolved to Grade 1 or less except for abnormal clinical values alopecia and peripheral neuropathy (participants with Grade 1 or 2 neuropathy without pain are eligible for enrollment).\n* Use of systemic corticosteroids exceeding 10 mg\u002Fday of prednisone or equivalent within 14 days prior to the first dose",{"count":71,"type":22},72,[25,73],"PHASE2","KK2430 (\"Study Drug\") as a potential treatment for people with Hematologic Neoplasms. KK2430 is an experimental drug; it has not been approved for the treatment of any disease by health authorities such as United States Food and Drug Administration (FDA), and this is the first time it will be given to people. The purpose of this Study is to find out more information about KK2430, whether it is safe in humans, how the body processes it, and if it works for treating your condition.",[76],"Hematologic Neoplasms","2026-06-01",{"date":79,"type":33},"2026-06-05",{"date":81,"type":22},"2026-06",{"date":83,"type":22},"2027-10",{"name":39,"class":40},1,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100637951","phase-2-a-phase-2-clinical-study-of-ziftomenib-in-patients-with-relapsed-or-refractory-npm1-mutated-acute-myeloid-leukemia-100637951","NCT07623616","A Phase 2 Clinical Study of Ziftomenib in Patients With Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia","A Phase 2, Multicenter, Open-Label Study of Ziftomenib Monotherapy in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia With NPM1 Mutation","Inclusion Criteria:\n\n* Voluntary written informed consent and willingness to comply with all study procedures\n* Age ≥ 18 years\n* Confirmed diagnosis of acute myeloid leukemia (AML)\n* Patients with R\u002FR AML with NPM1-m\n* No available standard of care expected to provide clinical benefit, ineligible for or declined standard therapy.\n* ECOG performance status 0-2.\n* White blood cell count ≤ 30,000\u002Fmm³ at screening (hydroxyurea permitted for cytoreduction).\n* Adequate organ function according to protocol requirements.\n* Women of childbearing potential must be willing to use a highly effective method of contraception throughout the study and for at least 187 days after the last dose of study treatment.\n* Males with female partners of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 97 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia.\n* Donor lymphocyte infusion \\\u003C 30 days prior to study entry.\n* Clinically active central nervous system (CNS) leukemia.\n* Prior hematopoietic stem cell transplantation (HSCT) without adequate hematologic recovery.\n* Active Grade ≥ 2 acute graft-versus-host disease or moderate\u002Fsevere chronic graft-versus-host disease.\n* Prior treatment with a menin inhibitor.\n* Receipt of chemotherapy, immunotherapy, radiotherapy, or investigational therapy within 14 days or 5 half-lives prior to first dose.\n* Unresolved toxicities from prior therapy \\> Grade 1.\n* Requirement for strong CYP3A4 inducers.\n* Active or uncontrolled infection, including hepatitis B, hepatitis C, or HIV.\n* Conditions predisposing to serious or life-threatening infection or significant immunodeficiency.\n* Cardiovascular disease or QTcF \\> 480 ms.\n* Interstitial lung disease.\n* Major surgery within 4 weeks prior to first dose.\n* Women who are pregnant or lactating\n* Any medical, psychiatric, or social condition that may interfere with study participation or safety, or that makes the patient unsuitable in the investigator's judgment.",{"count":94,"type":22},6,[73],"This is the first study to administer ziftomenib to Japanese patients. In this study, the efficacy, safety, and pharmacokinetics of ziftomenib will be evaluated in patients with relapsed or refractory NPM1-mutated acute myeloid leukemia",[98],"Acute Myeloid Leukemia (AML)","2026-05-28",{"date":101,"type":33},"2026-06-03",{"date":103,"type":33},"2026-04-23",{"date":105,"type":22},"2028-12",{"name":39,"class":40},20,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100535175","phase-1-a-clinical-study-of-kk2260-in-patients-with-advanced-or-metastatic-solid-tumors-100535175","NCT06248411","A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors","A Phase 1, Uncontrolled, Open-label, Non-randomized, Dose-escalation Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors, Followed by an Uncontrolled, Non-randomized Study and an Uncontrolled, Randomized Study in Patients With Esophageal Squamous Cell Carcinoma or Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n\\\u003CCommon Inclusion Criteria for Part 1a, Part 1b, and Part 2\n\n1. Patients who have given informed written consent.\n2. Male or female subjects ≥18 years of age, at time of signing informed consent.\n3. Subjects who are refractory to standard treatment, intolerant of standard treatment, for whom standard treatment does not exist, or who have refused standard treatment.\n4. Patients with measurable disease according to RECIST version 1.1\n5. Patients who have had the certaion periods between the date of completion of prior therapy and the date of enrollment\n6. Subjects who agree to have a tumor biopsy as part of the baseline examination. Patients who have difficulty in performing a tumour biopsy and have agreed to submit a previously collected stored specimen.\n7. Patients with an ECOG PS of 0 or 1 at baseline.\n8. Patients with haematopoietic, hepatic, renal, cardiac and respiratory functions that meet certain criteria in a baseline test.\n\n\\\u003CAdditional Inclusion Criteria for Part 1a\n\n1\\) Patients with pathologically diagnosed advanced or metastatic solid tumors.\n\n\\\u003CAdditional Inclusion Criteria for Part 1b\n\n1. Patients with pathologically diagnosed with advanced or metastatic esophageal cancer, or advanced or metastatic head and neck cancer whose primary site of origin is the oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, or paranasal sinuses.\n2. Patients with pathologically diagnosed squamous cell carcinoma.\n3. Patients who agree to undergo tumor biopsy after administration.\n\n\\\u003CAdditional Inclusion Criteria for Part 2a\n\n1. Patients with pathologically diagnosed with advanced or metastatic esophageal cancer.\n2. Patients with pathologically diagnosed squamous cell carcinoma.\n3. Patients who agree to undergo tumor biopsy after administration.\n\n\\\u003CAdditional Inclusion Criteria for Part 2b\n\n1. Patients with advanced or metastatic head and neck cancer whose primary site of origin is the oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, or paranasal sinuses.\n2. Patients with pathologically diagnosed squamous cell carcinoma.\n3. Patients who agree to undergo tumor biopsy after administration.\n\nExclusion Criteria:\n\n\\\u003CCommon Exclusion Criteria to Part 1 and Part 2\\>\n\n1. Patients with central or brain pia mater metastases that are untreated and symptomatic or that require treatment.\n2. Patients with concurrent multiple or synchronous cancers, or with iatrogenic multiple or synchronous cancers with a disease-free interval of 5 years or less.\n3. Patients receiving continuous systemic administration of steroids or other immunosuppressive drugs.\n4. Patients who have had a Grade 3 or higher allergic reaction to an antibody agent or an additive of the study drug.\n5. Patients who have not recovered to Grade 1 or below from adverse events caused by previously administered anticancer therapy.\n6. Patients with active interstitial lung disease or a history of active interstitial lung disease.\n7. Patients with infectious diseases requiring systemic treatment.\n8. Patients with a fever of 38.0°C or higher at the time of registration.\n9. Patients who test positive for Hepatitis B virus antigen or antibody, Hepatitis C virus antibody, or HIV antibody in a baseline test.",{"count":116,"type":22},189,[25],"This is the first in human study of KK2260. In Part 1a, the maximum tolerated dose (MTD) will be determined while evaluating the safety and tolerability of KK2260 in patients with advanced or metastatic solid tumors (any cancer type). In Part 1b and Part 2, at least two dosing regimens and two dosing regimens by cancer type, respectively, will be selected, and the safety, tolerability, and efficacy of each regimen will be evaluated.",[120],"Advanced or Metastatic Solid Tumors","2026-05-25",{"date":123,"type":33},"2026-05-27",{"date":125,"type":33},"2023-11-01",{"date":127,"type":22},"2030-04-30",{"name":39,"class":40},14,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},"100536551","phase-1-a-study-of-kk2269-in-adult-participants-with-solid-tumors-100536551","NCT06266299","A Study of KK2269 in Adult Participants With Solid Tumors","A Phase 1, Multicenter, Open-label, Dose-escalation Study Evaluating the Safety and Tolerability of Intravenous KK2269 Monotherapy and Combination Therapy With Docetaxel in Adult Participants With Solid Tumors","* Key Common Inclusion Criteria for Parts 1 and 2:\n\n  * Patients who are ≥ 18 years old at the time of informed consent\n  * Patients who have disease measurable by RECIST v1.1\n  * Patients with an ECOG PS of 0 or 1\n  * Patients with a life expectancy of at least 3 months in the judgement of the investigator or subinvestigator\n  * The specified periods have passed respectively after the completion of previous cancer treatments as of the date of enrollment at the time of the first dose of KK2269\n  * Patients who agree to use a medically effective method of contraception\n* Key Additional Inclusion Criterion for Part 1:\n\n  •Patients with histological or cytological evidence of at least one locally advanced or metastatic non-CNS solid tumor\n* Key Additional Inclusion Criteria for Part 2:\n\n  •Patients with histological or cytological evidence of any of the following disease: Gastric adenocarcinoma, GEJ adenocarcinoma, or esophageal adenocarcinoma, NSCLC (Only patients with NSCLC will be enrolled in the expansion part)\n\n  •Patients who are suitable for docetaxel treatment\n* Key Common Exclusion Criteria for Parts 1 and 2:\n\n  * Patients with an uncontrolled or serious intercurrent illness\n  * Patients with known active central nervous system metastasis\n  * Patients with a history of ≥ Grade 3 allergic reaction to any antibody drug\n  * Patients with a history of autoimmune disease\n  * Patients with a history of HIV, HBV, or HCV at screening\n  * Patients who have a history of primary immunodeficiency\n* Key Additional Exclusion Criterion For Part 2:\n\n  * Patients with a history of treatment with docetaxel",{"count":138,"type":22},101,[25],"This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1. In Part 1, the primary objective is to assess the safety and tolerability of KK2269.\n\nIn Part 2, only participants with gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC who have experienced at least one systemic therapy will be enrolled. In Part 2, the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel and to determine the recommended dose(s) and dose interval(s) of KK2269 in combination with docetaxel for subsequent studies.\n\nIn both Part 1 and Part 2, participants who refuse to undergo standard therapy are also eligible.",[142,143,144,145,146,147],"Advanced Solid Tumor","Metastatic Solid Tumor","Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Esophageal Adenocarcinoma","Non Small Cell Lung Cancer","2026-01-26",{"date":150,"type":33},"2026-01-28",{"date":152,"type":33},"2024-01-18",{"date":154,"type":22},"2029-03",{"name":39,"class":40},11,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":168,"conditions":169,"keywords":171,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},"100556479","phase-1-a-first-in-human-study-of-kk8123-in-adults-with-x-linked-hypophosphatemia-100556479","NCT06525636","A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia","A Multicenter, Open-label, Phase 1\u002F2, Dose-escalation and Subsequent Safety Extension Study of Subcutaneous KK8123 in Adult Patients With X-linked Hypophosphatemia","Inclusion Criteria:\n\n* Part 1: Inclusion Criteria:\n\n  1. Male or female patients aged 18 to 65 years inclusive at the time of signing the ICF.\n  2. Body weight is at least 40 kg.\n  3. Diagnosed with XLH (as documented by the investigator).\n  4. Have a value of fasting serum phosphorus \\\u003C 2.5 mg\u002FdL (0.81 mmol\u002FL) at Screening.\n  5. Have a value of renal TmP\u002FGFR \\\u003C 2.5 mg\u002FdL (0.81 mmol\u002FL) at Screening.\n  6. eGFR ≥ 60 mL\u002Fmin (using the Chronic Kidney Disease Epidemiology Collaboration equation \\[Inker, 2021\\]) at Screening.\n  7. Have a corrected serum calcium level \\\u003C 10.8 mg\u002FdL (2.7 mmol\u002FL) at Screening.\n  8. Provide a signed ICF.\n  9. Agree not to change diet and exercise regimen from one week prior to dosing to end of study.\n  10. Have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study (female participants only).\n  11. If taking chronic pain medications (including narcotic pain medications\u002Fopioids), must be on a stable regimen for at least 21 days prior to the Screening visit, and be willing to maintain medications at the same stable dose(s) and schedule throughout the clinical trial. The dose must not exceed 60 mg oral morphine equivalents\u002Fday.\n  12. Be willing to use a method of contraception following local country guidelines while participating in the study and for 5 months after the last dose (all sexually active participants of childbearing potential).\n\n      Women of non-childbearing potential are defined as permanently sterile (i.e., due to tubal ligation at least one year before Screening, hysterectomy or bilateral oophorectomy) or postmenopausal (defined as at least 12 months post cessation of menses without an alternative medical cause).\n\n      Postmenopausal status of female participants will be confirmed with a Screening serum follicle-stimulating hormone level \\>40 mIU\u002FmL.\n  13. Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments.\n\nExclusion Criteria:\n\n* Part 1: Exclusion Criteria:\n\n  1. For XLH patients previously treated with burosumab, use of burosumab within 7 months prior to ICF signature.\n  2. Prior history of positive test for human immunodeficiency virus antibody, positive test for hepatitis B surface antigen, and\u002For hepatitis C virus antibody at Screening.\n  3. History of hypersensitivity to any ingredient of any therapeutic monoclonal antibody.\n  4. Have an active infection.\n  5. Grade 3 or greater nephrocalcinosis as confirmed by renal ultrasound.\n  6. Uncontrolled diabetes mellitus at Screening.\n  7. History of known immunodeficiency.\n  8. History of alcoholism or drug abuse.\n  9. History of donation of blood within 60 days prior to Screening.\n  10. Use of any IP or investigational medical device within 30 days prior to Screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.\n  11. Use of any therapeutic mAb within 90 days prior to Screening.\n  12. Use of pharmacologically active vitamin D, its metabolites or analogs, oral phosphate for treatment of XLH, aluminum hydroxide antacids, acetazolamide, thiazide diuretics, and\u002For systemic corticosteroids within 14 days prior to Screening. If the participant takes any of these medications, a washout period of 14 days will be required after signing the ICF and before any other screeening assessments begin.\n  13. Use of medication to suppress PTH (e.g., calcimimetics) within 2 months prior to Screening and for the duration of the study.\n  14. Use of denosumab within 6 months prior to Screening.\n  15. Use of oral bisphosphonates in the 2 years prior to Screening.\n  16. Use of teriparatide or abaloparatide in the 2 months prior to Screening.\n  17. Plasma iPTH ≥ 2.5 × ULN at Screening.\n  18. Planned or recommended orthopedic surgery during the study.\n  19. History of traumatic fracture or orthopedic surgery within 6 months prior to Screening.\n  20. Participants who are lactating.\n  21. Current active and symptomatic COVID-19 infection at Day -1.\n  22. Presence or history of any condition that, in the view of the investigator, places the participant at high risk of poor treatment compliance or of not completing the study, or that would confound safety or interpretation of results.\n\nPart 2: Inclusion Criteria:\n\n1. Completion of relevant cohort in Part 1 of the study.\n2. Provide a signed informed consent after the nature of Part 2 of the study has been explained.\n3. Body weight is at least 40 kg.\n4. Negative pregnancy test at Week 0 of Part 2 and willing to have additional pregnancy tests until the end of the study (female participants only).\n5. If taking chronic pain medications (including narcotic pain medications\u002Fopioids), must be on a stable regimen for at least 21 days prior to Week 0 of Part 2, and be willing to maintain medications at the same stable dose(s) and schedule throughout the study. The dose must not exceed 60 mg oral morphine equivalents\u002Fday.\n6. Be willing to use a method of contraception following local country guidelines while participating in the study and for 5 months after the last dose (all sexually active participants of childbearing potential). Women of non-childbearing potential are defined as permanently sterile (i.e., due to tubal ligation at least one year before Screening, hysterectomy or bilateral oophorectomy) or postmenopausal (defined as at least 12 months post cessation of menses without an alternative medical cause). Postmenopausal status of female participants will be confirmed with a Week 0 serum follicle-stimulating hormone level \\>40 mIU\u002FmL.\n7. Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with all the assessments.\n\nPart 2: Exclusion Criteria:\n\n1. Use of burosumab following completion of Part 1 of the study.\n2. Have an active infection.\n3. Donation of blood within 60 days prior to Week 0 of Part 2.\n4. Use of any investigational product other than KK8123, or investigational medical device, within 30 days prior to Week 0 of Part 2, or requirement for any investigational agent prior to completion of all scheduled study assessments.\n5. Use of any therapeutic mAb other than KK8123 within 90 days prior to Week 0 of Part 2.\n6. Use of pharmacologically active vitamin D, its metabolites or analogs, oral phosphate for treatment of XLH, aluminum hydroxide antacids, acetazolamide, thiazide diuretics, and\u002For systemic corticosteroids within 14 days prior to Week 0 of Part 2.\n7. Use of medication to suppress PTH (e.g., calcimimetics) within 2 months prior to Week 0 of Part 2.\n8. Use of oral bisphosphonates following completion of Part 1 of the study.\n9. Use of teriparatide or abaloparatide in the 2 months prior to Week 0 of Part 2.\n10. Planned or recommended orthopedic surgery during the study.\n11. History of traumatic fracture or orthopedic surgery within 6 months prior to Week 0 of Part 2.\n12. Participants who are lactating.\n13. Current active and symptomatic COVID-19 infection, or a history of suffering any long-term sequalae from COVID-19 infection.\n14. Presence or history of any condition that, in the view of the investigator, places the participant at high risk of poor treatment compliance or of not completing the study.","65 Years",{"count":166,"type":22},24,[25,73],"A first-in-human study of KK8123 in adults with X-linked hypophosphatemia.",[170],"X-linked Hypophosphatemia",[172,173,174,175,176,177,178,179,180],"Gene Mutation","Bone Disease","Metabolic Disease","Musculoskeletal Disease,","Rare Disease","Hypophosphatemia","Familial Renal Tubular Transport","Inborn Errors","Kidney Diseases","2025-11-12",{"date":183,"type":33},"2025-11-14",{"date":185,"type":33},"2024-10-09",{"date":187,"type":22},"2028-05-10",{"name":39,"class":40},9,{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":196,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":199,"phases":4,"briefSummary":200,"conditions":201,"keywords":204,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":94},"100603134","assessment-of-safety-and-efficacy-of-poteligeo-inj-20-mg-mogamulizumab-through-use-result-surveillance-100603134","NCT07132567","Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance","Inclusion Criteria:\n\n1. Adults 19 years of age or older\n2. Individuals who are confirmed to have received administration of the study drug for the purpose of \"the treatment for adult patients with fungoidal granuloma or Sezary syndrome who have received one or more systemic therapies,\" or who are considered to require administration of the study drug in the investigator's opinion\n3. Individuals who (or whose legally acceptable representatives) signed the Consent to Use of Personal Information of their own free will for participation in this use-result surveillance\n\nExclusion Criteria\n\n1. Patients with hypersensitivity to any ingredients of this drug\n2. Patients who intend to use this drug for non-approved indications\n3. Patients who participated in a pre-market clinical trial of the study drug and received administration of the study drug","19 Years",{"count":198,"type":22},15,"OBSERVATIONAL","The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings.",[202,203],"Mycosis Fungoides","Sezary Syndrome",[205,206,207],"Poteligeo","mycosis fungoides","Sezary syndrome","2025-09-19",{"date":210,"type":33},"2025-09-22",{"date":212,"type":33},"2025-05-02",{"date":214,"type":22},"2028-11",{"name":39,"class":40},{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":223,"maxAge":18,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":189},"100587292","phase-3-evaluate-the-efficacy-and-safety-of-kk8398-in-patients-with-achondroplasiaaoba-study-100587292","NCT06926491","Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study）","A Multicenter, Open-label, Single-arm, Phase 3 Study of KK8398 (Infigratinib) in Patients With Achondroplasia (AOBA Study)","Inclusion Criteria:\n\n1. Patients who are between 2.5 and 17.5 years old of age at the time of provisional registration. Patients who meet certain criteria in terms of Tanner stage and bone age.\n2. Patients who have been diagnosed with achondroplasia through genetic testing.\n\nExclusion Criteria:\n\n1. Patients who meet the criteria for a certain height determined by age and gender in the \"Growth Chart for Patients with Achondroplasia\" at the time of the pre-registration examination\n2. Patients who have received treatment with r-hGH or a CNP analogue within a certain period prior to the pre-enrollment examination.\n3. Patients who have had previous osteotomy or who are scheduled to undergo osteotomy or epiphyseal growth inhibition during the study period. Epiphyseal growth inhibition in which the plate was removed more than 26 weeks prior to the pre-registration examination will not be excluded if the patient has completely healed without sequelae, based on the judgment of the investigator or sub-investigator.","3 Years",{"count":94,"type":22},[226],"PHASE3","This trial will evaluate the efficacy of KK8398 on annualized height velocity after 52 weeks of repeated administration of KK8398 to patients with achondroplasia",[229],"Achondroplasia","2025-04-28",{"date":232,"type":33},"2025-04-29",{"date":234,"type":33},"2024-12-01",{"date":236,"type":22},"2031-05-31",{"name":39,"class":40},{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":4,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":244,"phases":4,"briefSummary":245,"conditions":246,"keywords":248,"overallStatus":253,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":257,"locationsCount":4},"100345245","expanded-access-to-burosumab-100345245","NCT03775187","Expanded Access to Burosumab","Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-","EXPANDED_ACCESS","Individual patient expanded access requests may be considered for patients who have no other treatment options",[170,247],"Tumor-Induced Osteomalacia",[249,250,251,252],"Expanded Access","Compassionate Use","XLH","TIO","AVAILABLE","2025-02-28",{"date":256,"type":33},"2025-03-05",{"name":39,"class":40},""]