[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hrr-deficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hrr-deficiency":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,67],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100599753","phase-1-study-of-syn608-for-the-treatment-of-advanced-or-metastatic-solid-tumors-100599753",false,"NCT07088588","Study of SYN608 for the Treatment of Advanced or Metastatic Solid Tumors","A First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SYN608, a Poly ADP-ribose Glycohydrolase (PARG) Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Having signed the written Informed Consent Form (ICF);\n* Male or female aged ≥18 years;\n* Life expectancy ≥12 weeks;\n* Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1;\n* Patients with histologically or cytologically confirmed locally advanced or metastatic breast cancer, ovarian cancer or other advanced solid tumors who have experienced disease progression, and available standard of care (SOC) therapies had been exhausted;\n* be willing to provide tumor tissue samples (fresh frozen \\[SF\\] or previously retained paraffin-embedded \\[FFPE\\] tumor tissue samples) or peripheral blood germline DNA or ctDNA sample to detect BRCA mutation, or other deficiency in the Homologous Recombination (HR) pathway (by the detection method of next generation sequencing \\[NGS\\])\n* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;\n* No serious hematological, cardiopulmonary, or liver or kidney diseases other than the primary disease;\n* Adequate organ function and bone marrow function.\n\nExclusion Criteria:\n\n* Previous or current use of Poly (ADP) ribose glycohydrolase (PARG) inhibitors;\n* Serious allergy to the study drug or any of its excipients;\n* Current or previous other malignancy unless treated radically and with no evidence of recurrence or metastasis within the past 5 years;\n* Central nervous system (CNS) metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that CNS metastasis or meningeal metastasis has not been adequately controlled;\n* Patients with Myelodysplastic syndrome (MDS)\u002FAcute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML;\n* Dysphagia or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunts, or gastrointestinal disorders that affect drug absorption, e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome, or other malabsorption conditions;\n* Treatment with an anti-cancer small molecule within 5 half-lives (t1\u002F2), or 2 weeks, whichever is shorter;\n* History of use within 2 weeks prior to the first dose of the study treatment and need to use protocol-prohibited potent inhibitors or potent inducers of cytochrome P450 (CYP) 3A4\u002FBCRP\u002FP-gp during the study;\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease;\n* Serious systemic diseases or laboratory abnormalities or other conditions that, at the Investigator's discretion, will make it unsuitable for the patient to participate in this clinical trial.","ALL","18 Years",{"count":19,"type":20},105,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN608 as monotherapy in adult patients with advanced solid tumors",[26,27,28,29,30,31],"Advanced Solid Cancer","Metastatic Solid Tumor","Ovarian Cancer","Breast Cancer","BRCA Mutation","HRR Deficiency","NOT_YET_RECRUITING","2025-07-25",{"date":35,"type":36},"2025-07-28","ACTUAL",{"date":38,"type":20},"2025-07-31",{"date":40,"type":20},"2028-10-31",{"name":42,"class":43},"Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd","INDUSTRY",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":44},"100567290","phase-1-study-of-syn818-for-the-treatment-of-advanced-or-metastatic-solid-tumors-100567290","NCT06666270","Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors","A First-in-human, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumor Activity of SYN818, a DNA Polymerase Theta (POLQ) Inhibitor Alone in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Having signed the written Informed Consent Form (ICF);\n* Male or female aged ≥18 years;\n* Life expectancy ≥12 weeks;\n* Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1;\n* Patients with histologically or cytologically confirmed locally advanced or metastatic breast cancer, ovarian cancer, prostate cancer or other advanced solid tumors who have experienced disease progression, and available SOC therapies had been exhausted;\n* be willing to provide tumor tissue samples (fresh frozen \\[SF\\] or previously retained paraffin-embedded \\[FFPE\\] tumor tissue samples) or peripheral blood germline DNA or ctDNA sample to detect BRCA mutation, or other deficiency in the HR pathway (by the detection method of next generation sequencing \\[NGS\\])\n* At least one measurable lesion according to RECIST v1.1;\n* No serious hematological, cardiopulmonary, or liver or kidney diseases other than the primary disease;\n* Adequate organ function and bone marrow function.\n\nExclusion Criteria:\n\n* Previous or current use of POLQ inhibitors;\n* Hypersensitivity to the active pharmaceutical ingredient or any excipient of SYN818;\n* Central nervous system (CNS) metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that CNS metastasis or meningeal metastasis has not been adequately controlled;\n* Other malignant tumors than the study tumors within 5 years prior to the first dose of the study drug, except for localized cancers that have been evidently cured or disease-free for at least 3 years, such as basal or squamous cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, carcinoma in situ of cervix, or carcinoma in situ of breast;\n* Patients with Myelodysplastic syndrome (MDS)\u002FAcute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML;\n* Dysphagia or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunts, or gastrointestinal disorders that affect drug absorption, e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome, or other malabsorption conditions;\n* Major surgery or serious trauma within 4 weeks prior to the first dose of the study treatment or major surgery planned during the trial period, and none of the AEs related to surgery or major trauma have resolved (to ≤ CTCAE v5.0 Grade 1 or baseline level) before the first dose of the study drug;\n* History of use within 2 weeks prior to the first dose of the study treatment and need to use protocol-prohibited potent inhibitors or potent inducers of cytochrome P450 (CYP) 3A4\u002FBCRP\u002FP-gp during the study;\n* Serious systemic diseases or laboratory abnormalities or other conditions that, at the Investigator's discretion, will make it unsuitable for the patient to participate in this clinical trial.",{"count":53,"type":20},30,[23],"This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 as monotherapy in adult patients with advanced solid tumors",[26,27,28,29,57,30,31],"Prostate Cancer","RECRUITING","2025-07-18",{"date":61,"type":36},"2025-07-20",{"date":63,"type":36},"2024-11-21",{"date":65,"type":20},"2026-12-30",{"name":42,"class":43},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100556453","phase-1-eis-12656-as-single-agent-and-in-combination-in-patients-with-specified-solid-tumors-100556453","NCT06525298","EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors","A Phase 1\u002F2, Open Label Trial to Investigate the Safety, Tolerability, and Preliminary Efficacy of EIS-12656 as Single Agent and in Combination With a Poly-ADP Ribose Polymerase (PARP) Inhibitor or Trastuzumab Deruxtecan (T-DXd), an Antibody Drug Conjugate (ADC), in Participants With Specified Solid Tumors","Inclusion Criteria:\n\n* Recurrent locally advanced or metastatic solid tumors\n* Homologous recombination deficient mutations\n* Progressed on at least on prior line of treatment or intolerant to additional effective standard therapy\n* Measurable disease (RECIST 1.1 Criteria)\n* Adequate organ and bone marrow function\n* ECOG Performance Status 0 or 1\n* Life expectancy \\> 3 months\n\nExclusion Criteria:\n\n* History or evidence of any clinically relevant gastrointestinal disease\n* Radiation therapy within ≤2 weeks\n* Significant cardiovascular disease\n* Uncontrolled, active, symptomatic brain metastases",{"count":75,"type":20},144,[23,77],"PHASE2","This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations. The trial consists of a dose escalation part (Phase 1) and a dose expansion part (Phase 2).",[80,81,31],"Advanced Solid Tumor","Homologous Recombination Deficiency","2024-09-14",{"date":84,"type":36},"2024-09-19",{"date":86,"type":36},"2024-09-09",{"date":88,"type":20},"2027-12",{"name":90,"class":43},"Eisbach Bio GmbH",1]