[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MOMA Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"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":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100590952","phase-1-study-of-orally-administered-moma-341-in-participants-with-advanced-or-metastatic-solid-tumors-100590952",false,"NCT06974110","Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors","A Phase 1 Study of MOMA-341 as Monotherapy or Combination Therapy in Participants With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Participants have unresectable advanced or metastatic solid tumors with MSI-H or dMMR alterations and histologically confirmed disease. Participants must have previously received and progressed on an anti-PD-(L)1-based regimen, unless ineligible or in a region without access to anti-PD-(L)1 therapies\n3. Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and\u002For PCWG-3\n4. ECOG PS ≤ 2\n5. Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and\u002For surgery \\*\\*hormonal therapy allowed. Palliative radiotherapy allowed\n6. Adequate organ function per local labs\n7. Comply with contraception requirements\n8. Written informed consent must be obtained according to local guidelines\n\nExclusion Criteria:\n\n1. Known Werner Syndrome\n2. Active prior or concurrent advanced-stage malignancy (some exceptions allowed including early-stage cancers)\n3. Clinically relevant cardiovascular disease\n4. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)\n5. Known active uncontrolled infection\n6. Known allergy, hypersensitivity, and\u002For intolerance to MOMA-341\n7. Impaired GI function that may impact absorption\n8. Patient is pregnant or breastfeeding\n9. Known to be HIV positive, unless all of the following criteria are met:\n\n   1. Undetectable viral load or CD4+ count ≥300 cells\u002FμL\n   2. Receiving highly active antiretroviral therapy\n   3. No AIDS-related illness within the past 12 months\n10. Active liver disease (some exceptions are allowed)\n11. Prior or ongoing condition, therapy, or laboratory abnormality that, in the investigator's opinion, may affect safety of the patient, confound the results of the study, and\u002For interfere with the patients participation in the study","ALL","18 Years",{"count":19,"type":20},132,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-341 administered orally as a single agent or combination therapy in patients with microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors.",[26,27,28,29,30,31,32],"Advanced Solid Tumor","Metastatic Solid Tumor","Endometrial Cancer","MSI-H Cancer","Colorectal Cancer","Gastric Cancer","dMMR Cancer",[34,35,36,37,26,27,31,30,28,29,32],"Phase 1","MOMA-341","Werner helicase","WRN","RECRUITING","2026-07-22",{"date":41,"type":42},"2026-07-23","ACTUAL",{"date":44,"type":42},"2025-07-16",{"date":46,"type":20},"2028-05",{"name":48,"class":49},"MOMA Therapeutics","INDUSTRY",15,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100558040","phase-1-study-of-orally-administered-moma-313-in-participants-with-advanced-or-metastatic-solid-tumors-100558040","NCT06545942","Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors","A Phase 1 Study of MOMA-313 Given as Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Have histologically confirmed disease for each treatment arm as follows:\n\n   1. Treatment Arm 1 (MOMA-313 Monotherapy)\n\n      \\- Advanced (including locally), relapsed or metastatic solid tumors that are not eligible for curative therapy, with any HR-deficient alteration.\n   2. Treatment Arm 2 (MOMA-313 in Combination with Olaparib):\n\n      * Dose escalation: Advanced (including locally), relapsed or metastatic solid tumors that are not eligible for curative therapy, for which a PARP inhibitor is indicated, with select HR-deficient mutations. Patients may be PARP inhibitor naive or exposed.\n      * Dose optimization: Advanced (including locally), relapsed or metastatic CRPC or pancreatic ductal adenocarcinoma (PDAC) with select HR-deficient mutations. Patients must be PARP inhibitor naive.\n3. Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and\u002For PCWG-3\n4. ECOG PS ≤ 2\n5. Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and\u002For surgery \\*\\*hormonal therapy allowed. Palliative radiotherapy allowed.\n6. Adequate organ function per local labs\n7. Comply with contraception requirements\n8. Written informed consent must be obtained according to local guidelines\n\nKey Exclusion Criteria:\n\n1. Active prior or concurrent malignancy (some exceptions allowed)\n2. Clinically relevant cardiovascular disease\n3. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)\n4. Known active infection\n5. Prior polymerase theta inhibitor exposure\n6. Known allergy, hypersensitivity, and\u002For intolerance to MOMA-313\n7. Olaparib exposed patients with known hypersensitivity to PARP inhibitors (for patients considered for olaparib only)\n8. Impaired GI function that may impact absorption.\n9. Patient is pregnant or breastfeeding.\n10. Known to be HIV positive, unless all of the following criteria are met:\n\n    1. Undetectable viral load or CD4+ count ≥300 cells\u002FμL\n    2. Receiving highly active antiretroviral therapy\n    3. No AIDS-related illness within the past 12 months\n11. Active liver disease (some exceptions are allowed)\n12. Prior or ongoing condition, therapy, or laboratory abnormality that, in the investigator's opinion, may affect safety of the patient, confound the results of the study, and\u002For interfere with the patients participation in the study",{"count":59,"type":20},220,[23],"This Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-313 administered orally as a single agent or combination therapy in patients with homologous recombinant deficient solid tumors.",[26,27,63,64,65,66,67],"Prostate Cancer","Pancreas Cancer","Breast Cancer","Ovarian Cancer","Homologous Recombination Deficiency",[34,69,70,48,26,27,63,64,65,66,67,71,72],"MOMA-313","Polymerase theta","HRD Mutation","Advanced (including locally)",{"date":41,"type":42},{"date":75,"type":42},"2024-08-13",{"date":77,"type":20},"2027-11-30",{"name":48,"class":49},18,""]