[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Danatlas Pharmaceuticals Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":110},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100642622","phase-2-a-study-of-dat-2645-in-patients-with-brca12-mutations-or-hrd-positive-ovarian-cancer-100642622",false,"NCT07652073","A Study of DAT-2645 in Patients With BRCA1\u002F2 Mutations or HRD-Positive Ovarian Cancer","A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of DAT-2645 in Patients With BRCA1\u002F2 Deleterious Mutations or HRD-Positive Advanced\u002FMetastatic Ovarian Cancer","Inclusion Criteria:\n\n* sign a written informed consent form\n* At least 18 years of age (inclusive)\n* Epithelial ovarian cancer confirmed by histopathology or cytopathology\n* BRCA1\u002F2 mutation or HRD-positive status\n* Patients who have failed standard treatment or are unable to tolerate standard treatment\n* Patients must have received no more than five prior treatment lines\n* At least one measurable lesion\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n* Bone marrow reserve and organ function must meet the requirements\n* Negative result on a blood pregnancy test for a woman of childbearing age\n\nExclusion Criteria:\n\n* Received small-molecule chemotherapy or targeted therapy within 2 weeks or 5 half-lives prior to the first dose\n* Received treatment with an anticancer biological therapy within 4 weeks prior to the first dose\n* Underwent major surgery within 4 weeks prior to the first dose\n* Has previously received treatment with a PARG inhibitor\n* Inadequate response to previous PARP inhibitor maintenance therapy\n* With central nervous system metastases\n* Patients with clinically significant cardiovascular or cerebrovascular diseases\n* Uncontrolled active infections requiring intravenous antibiotics or hospitalization\n* Adverse reactions from prior anticancer therapy have not yet resolved to a grade ≤1","FEMALE","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase II, multicenter, single-arm dose expansion trial planned to enroll up to 30 subjects with advanced or metastatic ovarian cancer. The Objective is to conduct a preliminary evaluation of the efficacy, the safety, tolerability and PK profile of DAT-2645",[26],"Advanced or Metastatic Ovarian Cancer","NOT_YET_RECRUITING","2026-06-21",{"date":30,"type":31},"2026-06-25","ACTUAL",{"date":33,"type":20},"2026-06-15",{"date":35,"type":20},"2028-03-30",{"name":37,"class":38},"Danatlas Pharmaceuticals Co., Ltd","INDUSTRY",2,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100592802","phase-1-phase-1-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-dat-1604-in-advanced-solid-tumor-100592802","NCT06998173","Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DAT-1604 in Advanced Solid Tumor","Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DAT-1604 Tablets as Monotherapy in the Advanced Solid Tumor","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Male or female aged ≥18 years.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.\n4. Advanced or metastatic solid tumor, which is refractory to standard therapies, or for which no standard therapies exist.\n5. Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis.\n6. Discontinued all previous treatments for cancer for at least 21 days or 5 half-lives, whichever is shorter, and recovered from the acute effects of therapy. Palliative radiotherapy must have completed 1 week prior to start of study treatment.\n7. At least 1 radiologically evaluable lesion (measurable and\u002For non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation by RECIST v1.1 for subjects.\n8. Acceptable hematologic, renal, hepatic, and coagulation functions independent of transfusions and granulocyte colony-stimulating factor indicated by the following laboratory values:\n\n   * Hemoglobin (Hgb) greater than or equal to 10 g\u002FdL;\n   * Leukocytes greater than or equal to 3,000\u002FmcL;\n   * Absolute neutrophil count greater than or equal to 1,500\u002FmcL;\n   * Platelets greater than or equal to 100,000\u002FmcL;\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN); if liver metastases, then ≤ 3 × ULN;\n   * Bilirubin ≤ 1.5 × ULN; \\\u003C 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome;\n   * Serum albumin ≥ 30 g\u002FL (3.0 g\u002FdL);\n   * Creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault Equation).\n9. Willingness to abide by protocol defined contraceptive requirements for the duration of the study.\n10. Estimated life expectancy of ≥12 weeks.\n\n    \\-\n\nExclusion Criteria:\n\n1. Subjects who are pregnant.\n2. Subjects with Myelodysplastic syndrome (MDS)\u002FAcute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML.\n3. Have ongoing interstitial lung disease or pneumonitis.\n4. Have any major gastrointestinal issues that could impact absorption of DAT-1604.\n5. Subjects with brain metastases (subjects with treated brain metastases could be eligible if follow-up brain imaging after central nervous system-directed therapy shows no evidence of progression at least more than 4 weeks without neuropsychiatric symptom).\n6. Have received a live vaccine within 30 days before the first dose of study treatment.\n7. Recent major surgery within 4 weeks prior to entry into the study.\n8. Have a history of allergy or hypersensitivity to study drug components.\n9. Persistent toxicities (\\[CTCAE\\] Grade \\> 1) from prior anticancer therapy, excluding alopecia and CTCAE Grade 2 peripheral neuropathy.\n10. Any of the following ECG findings at Screening, Admission and\u002For pre dose on Day 1:\n\n    * Any out of range ECG parameter(s) or abnormal finding(s) considered clinically significant by the Investigator;\n    * Any ECG finding that, in the opinion of the Investigator, may compromise interpretation of ECG for cardiac safety assessments and\u002For complicate interpretation of events that may occur post dose (e.g., QT not accurately measurable, conduction abnormalities);\n    * QTcF \\> 470 ms;\n    * Any of the following: History or current evidence of congenital long QT syndrome; history of Torsades de Pointes, concomitant medications known to prolong QT interval or history of medication-related QT prolongation;\n    * Resting HR \\\u003C50 bpm or \\>90 bpm when vital signs are measured at Screening or Admission.\n11. COVID-19 positive for active disease.\n12. Myocardial impairment of any cause (e.g., cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease or congestive heart failure) resulting in heart failure by New York Heart Association (NYHA) Criteria (Class III or IV staging).\n13. Current treatment with drugs known as sensitive substrates or substrates having a narrow therapeutic index of CYP2B6, CYP3A4, and transporters including OAT1 and OAT3.\n14. Have received inhibitors or inducers of P-gp within 2 weeks prior to receiving the first dose of study drug.\n15. Current treatment with drugs which can prolong QTc in adverse reaction.\n16. Current treatment with highly competitive protein binding medications, such as warfarin, phenytoin, chlorpromazine, doxorubicin, gentamicin, indomethacin, metoprolol, meclezine.\n17. Known hypersensitivity to study drug(s) or any of its constituents.\n18. Unwilling or unable to follow study restrictions and requirements","ALL",{"count":49,"type":20},228,[51],"PHASE1","The primary objective of the study is to evaluate the safety, tolerability, PK, and preliminary efficacy of a Polθ Inhibitor DAT-1604 in patients with advanced\u002Fmetastatic solid tumors, which is refractory to standard therapies, or for which no standard therapies exist.",[54],"Advanced Solid Tumors",[56,54,57],"Polθ Inhibitor","Metastatic Solid Tumors","2025-05-28",{"date":60,"type":31},"2025-05-31",{"date":62,"type":20},"2025-07-31",{"date":64,"type":20},"2028-07-30",{"name":37,"class":38},1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":89,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":39},"100563329","phase-1-a-parg-inhibitor-dat-2645-monotherapy-in-patients-with-advancedmetastatic-solid-tumors-harboring-brca12-loss-of-function-alterations-andor-other-defects-in-the-ddr-pathway-100563329","NCT06614751","A PARG Inhibitor DAT-2645 Monotherapy in Patients with Advanced\u002FMetastatic Solid Tumors Harboring BRCA1\u002F2 Loss of Function Alterations And\u002For Other Defects in the DDR Pathway","A Phase I, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of DAT-2645 in Patients with Advanced\u002FMetastatic Solid Tumors Harboring BRCA1\u002F2 Loss of Function Alterations And\u002For Other Defects in the DNA Damage Repair Pathway","Inclusion Criteria:\n\n* Signed informed consent prior to initiation of any procedures in this study.\n* At least 18 years of age (inclusive).\n* Evidence of an DDR deficiency status in tumor tissue determined by validated testing method.\n* Patients with advanced or metastatic solid tumor who have failed standard of care therapy, or are unable to tolerate standard of care therapy, or unable to obtain\u002Funwilling to receive standard therapy. Regardless of PARP inhibitors were used or not in previous treatment.\n* At least one measurable lesion by RECIST v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0\\~2.\n* Life expectancy at least 3 months.\n* Adequate hematologic and non-hematologic function during the screening.\n* Women of childbearing potential must have a negative result of serum pregnancy test at screening.\n* Women of childbearing potential or male patients whose spouse have childbearing potential must agree to use a reliable and effective method of contraception during the study and for 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* Patients who received systemic chemotherapy, small-molecule targeted drugs within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n* Patients who received biological anti-tumor drugs (including immunotherapy, target therapy, antibody-drug conjugate \\[ADC\\]) within 4 weeks prior to the first dose of the study drug.\n* Patients who have undergone major surgery within 4 weeks prior to the first dose of study drug.\n* Patients who have received radiotherapy within 4 weeks prior to the first dose of study drug (palliative radiotherapy for non-target lesions could be acceptable if it was performed before 14 days prior to the first dose of study drug).\n* Any previous treatment with a PARG inhibitor.\n* Patients with active CNS metastases (patients with asymptomatic CNS metastases which are imaging stable and not require steroid treatment within 28 days prior to the first dose of study drug, and previous treated breast cancer brain metastasis, can only be enrolled in the Part 2 study).\n* Patients who have second primary malignant tumors within the past 3 years prior to screening, except for those who have been cured of basal cell carcinoma, cervical carcinoma in situ, or breast carcinoma in situ.\n* Patients with clinically significant cardiovascular or cerebrovascular diseases.\n* Active uncontrolled infections requiring intravenous antibiotics or hospitalization.\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of DAT-2645 and no history of bowel obstruction within 6 months prior to enrollment.\n* Known pulmonary interstitial disease or pulmonary interstitial fibrosis.\n* Patients known hypersensitivity to any component or excipient of DAT-2645.\n* Any unresolved toxicities from any prior therapy with severity great than CTCAE Grade 1 prior to start of DAT-2645, except for alopecia and pigmentation and Grade 2 of peripheral sensory neuropathy.\n* Participated in other clinical trials (except for screening failure) within 4 weeks prior to the first dose of the study drug in this study.\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (active HBV infection is defined as positive hepatitis B surface antigen \\[HbsAg\\], or HBV DNA exceeding the lower limit of detection; active HCV infection is defined as positive anti-HCV antibody, and HCV RNA exceeding the lower limit of detection).\n* Known human immunodeficiency virus (HIV) infection (patients with adequate CD4+ T cell counts and without history of acquired immune deficiency syndrome \\[AIDS\\]-defining opportunistic infections could be enrolled after consultation with sponsor).\n* Women who are pregnant or breastfeeding.\n* History or evidence of any other clinically significant condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, would be a risk to patient safety or interfere with the study evaluation, procedures or completion.",{"count":75,"type":20},112,[51],"The primary objective of the study is to evaluate the safety, tolerability, PK, PD, and prilimary efficacy of a PARG inhibitor DAT-2645 in patients with advanced\u002Fmetastatic solid tumors harboring BRCA1\u002F2 loss of function alterations and\u002For other defects in the DNA damage repair (DDR) pathway.",[79,80,81,82,83,84,85,86,87,88,57],"Solid Cancers","BRCA Mutation","HRD Cancer","Breast Cancer","Prostate Cancer","Colorectal Cancer","Pancreatic Cancer","Endometrial Cancer","Gastric Cancer","Advanced Cancer",[90,91,92,93,94,95,96,97,98,99,100,101],"PARGi","DAT-2645","PARPi","Advanced solid tumors","Metastatic solid tumors","HRD gene alteration","Homologous recombination","BRCA","BRCA1\u002F2","PALB2","RAD51C","RAD51D","2024-09-26",{"date":104,"type":31},"2024-09-27",{"date":106,"type":20},"2024-11-01",{"date":108,"type":20},"2027-06-01",{"name":37,"class":38},""]