[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06545942":3,"trial-entities:NCT06545942":238,"trial-summary:NCT06545942":247},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":26,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":36,"interventions":39,"primary_outcomes":50,"secondary_outcomes":55,"sex":89,"minimum_age":90,"maximum_age":91,"healthy_volunteers":15,"eligibility_criteria":92,"std_ages":98,"locations":101,"central_contacts":229,"overall_officials":235,"references":236,"see_also_links":237},"NCT06545942","MOMA-313-001","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","RECRUITING","2027-11-30","2026-07","2026-07-23","2024-08-13","MOMA Therapeutics","INDUSTRY",false,"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.","MOMA-313 is a novel therapeutic agent designed to target homologous recombination (HR)-deficient cancers by inhibiting DNA polymerase theta. MOMA-313 is being developed as a single-agent and in combination with a poly (adenosine diphosphate ribose) polymerase (PARP) inhibitor in patients with HR-deficient advanced (including locally), relapsed or metastatic solid tumors.\n\nThis phase 1, first-in-human, open-label study of MOMA-313 is primarily intended to evaluate the safety and tolerability of MOMA-313 when administered orally as a single agent (Treatment Arm 1) or in combination with olaparib (Treatment Arm 2). Each treatment arm of the study includes a dose-escalation phase followed by a dose-optimization phase. In the dose-escalation phase of each treatment arm, successive cohorts of patients will receive increasing oral doses of MOMA-313 as a single agent or in combination with olaparib to determine the presumptive optimal biologic dose(s) (OBD) in this population. The dose-optimization phase of each arm will enroll additional patients to support the confirmation of the OBD.\n\nThe data from this study conducted in patients with HR-deficient advanced (including locally), relapsed or metastatic solid tumors, including safety, tolerability, PK\u002FPDx findings, and antitumor activity, will form the basis for subsequent clinical development of MOMA-313 as a single-agent and in combination with olaparib.",[19,20,21,22,23,24,25],"Advanced Solid Tumor","Metastatic Solid Tumor","Prostate Cancer","Pancreas Cancer","Breast Cancer","Ovarian Cancer","Homologous Recombination Deficiency",[27,28,29,13,19,20,21,22,23,24,25,30,31],"Phase 1","MOMA-313","Polymerase theta","HRD Mutation","Advanced (including locally)","INTERVENTIONAL","TREATMENT",[35],"PHASE1",{"count":37,"type":38},220,"ESTIMATED",[40,46],{"type":41,"name":28,"description":42,"armGroupLabels":43},"DRUG","MOMA-313 administered orally",[44,45],"MOMA-313 Monotherapy (Treatment Arm 1)","MOMA-313 in Combination with Olaparib (Treatment Arm 2)",{"type":41,"name":47,"description":48,"armGroupLabels":49},"Olaparib","Olaparib administered orally",[45],[51],{"measure":52,"description":53,"timeFrame":54},"Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and\u002For AEs leading to discontinuation","To assess the safety and tolerability of MOMA-313 given as a single-agent or in combination with olaparib","From screening until treatment discontinuation (up to 35 months)",[56,59,62,64,66,68,70,74,77,80,83,86],{"measure":57,"description":58,"timeFrame":54},"Identify the recommended phase 2 dose (RP2D)","Determine the RP2D of MOMA-313 as a single-agent or in combination with olaparib",{"measure":60,"timeFrame":61},"PK parameter: area under curve (AUC) of MOMA-313","Up to 6 weeks with sparse sampling up to 35 months",{"measure":63,"timeFrame":61},"PK parameter: maximum concentration (Cmax) of MOMA-313",{"measure":65,"timeFrame":61},"PK parameter: time to maximum concentration of MOMA-313",{"measure":67,"timeFrame":61},"PK parameter: half-life of MOMA-313",{"measure":69,"timeFrame":61},"Plasma concentration of olaparib",{"measure":71,"description":72,"timeFrame":73},"Objective response rate (ORR)","ORR is defined as the percentage of subjects with evidence of a complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and\u002For Prostate Cancer Working Group-3 (PCWG-3).","Up to 35 months",{"measure":75,"description":76,"timeFrame":73},"Duration of response (DOR)","DOR is defined as time from first documented PR or better to disease progression (as assessed by RECIST v1.1 and\u002For PCWG-3 by Investigator assessment) or death whichever is earlier for participants who have achieved a CR or PR",{"measure":78,"description":79,"timeFrame":73},"Time to response (TTR)","TTR is defined as the period of time from the date of first dose of study treatment until the first objective documentation of a CR or PR per RECIST 1.1 and\u002For PCWG-3.",{"measure":81,"description":82,"timeFrame":73},"Progression free survival (PFS)","PFS is time from first dose of study treatment to progressive disease or death from any cause, whichever is earlier, as assessed via RECIST v1.1 and\u002For PCWG-3 by Investigator assessment",{"measure":84,"description":85,"timeFrame":73},"Disease control rate (DCR)","DCR defined by the proportion of subjects who achieved either a complete response (CR), partial response (PR), or stable disease (SD) at their first scheduled disease assessment according to disease-specific response criteria.",{"measure":87,"description":88,"timeFrame":73},"Overall survival (OS)","OS is defined as the time from first dose of study treatment to the date of death, irrespective of the cause of death","ALL","18 Years",null,{"inclusion":93,"exclusion":96,"raw_text":97},[94,95],"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.","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. 3. Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and\u002For PCWG-3 4. ECOG PS ≤ 2 5. Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and\u002For surgery \\*\\*hormonal therapy allowed. Palliative radiotherapy allowed. 6. Adequate organ function per local labs 7. Comply with contraception requirements 8. Written informed consent must be obtained according to local guidelines",[],"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",[99,100],"ADULT","OLDER_ADULT",[102,111,119,127,135,143,150,154,162,170,178,186,194,201,204,210,217,223],{"facility":103,"status":8,"city":104,"state":105,"zip":106,"country":107,"geoPoint":108},"Investigative Site #108","Goodyear","Arizona","85338","United States",{"lat":109,"lon":110},33.43532,-112.35821,{"facility":112,"status":8,"city":113,"state":114,"zip":115,"country":107,"geoPoint":116},"Investigative Site #101","La Jolla","California","92093",{"lat":117,"lon":118},32.84727,-117.2742,{"facility":120,"status":121,"city":122,"state":114,"zip":123,"country":107,"geoPoint":124},"Investigative Site #111","COMPLETED","San Francisco","94143",{"lat":125,"lon":126},37.77493,-122.41942,{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":107,"geoPoint":132},"Investigative Site #104","Lake Mary","Florida","32746",{"lat":133,"lon":134},28.75888,-81.31784,{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":107,"geoPoint":140},"Investigative Site #110","St Louis","Missouri","63110",{"lat":141,"lon":142},38.62727,-90.19789,{"facility":144,"status":8,"city":145,"state":145,"zip":146,"country":107,"geoPoint":147},"Investigative Site #103","New York","10016",{"lat":148,"lon":149},40.71427,-74.00597,{"facility":151,"status":8,"city":145,"state":145,"zip":152,"country":107,"geoPoint":153},"Investigative Site #106","10065",{"lat":148,"lon":149},{"facility":155,"status":8,"city":156,"state":157,"zip":158,"country":107,"geoPoint":159},"Investigative Site #109","Philadelphia","Pennsylvania","19104",{"lat":160,"lon":161},39.95238,-75.16362,{"facility":163,"status":121,"city":164,"state":165,"zip":166,"country":107,"geoPoint":167},"Investigative Site #107","Myrtle Beach","South Carolina","29572",{"lat":168,"lon":169},33.68906,-78.88669,{"facility":171,"status":8,"city":172,"state":173,"zip":174,"country":107,"geoPoint":175},"Investigative Site #102","Nashville","Tennessee","37203",{"lat":176,"lon":177},36.16589,-86.78444,{"facility":179,"status":121,"city":180,"state":181,"zip":182,"country":107,"geoPoint":183},"Investigative Site #105","San Antonio","Texas","78229",{"lat":184,"lon":185},29.42412,-98.49363,{"facility":187,"status":121,"city":188,"state":189,"zip":190,"country":107,"geoPoint":191},"Investigative Site #112","Fairfax","Virginia","22031",{"lat":192,"lon":193},38.84622,-77.30637,{"facility":195,"status":8,"city":196,"country":197,"geoPoint":198},"Investigative Site #114","Barcelona","Spain",{"lat":199,"lon":200},41.38879,2.15899,{"facility":202,"status":8,"city":196,"country":197,"geoPoint":203},"Investigative Site #116",{"lat":199,"lon":200},{"facility":205,"status":8,"city":206,"country":197,"geoPoint":207},"Investigative Site #115","Madrid",{"lat":208,"lon":209},40.4165,-3.70256,{"facility":211,"status":8,"city":212,"country":213,"geoPoint":214},"Investigative Site #113","London","United Kingdom",{"lat":215,"lon":216},51.50853,-0.12574,{"facility":218,"status":8,"city":219,"country":213,"geoPoint":220},"Investigative Site #117","Manchester",{"lat":221,"lon":222},53.48095,-2.23743,{"facility":224,"status":8,"city":225,"country":213,"geoPoint":226},"Investigative Site #118","Newcastle upon Tyne",{"lat":227,"lon":228},54.97328,-1.61396,[230],{"name":231,"role":232,"phone":233,"email":234},"MOMA Clinical Trials","CONTACT","(857) 285-3677","clinicaltrials@momatx.com",[],[],[],{"nct_id":4,"conditions":239,"biomarkers":245},[240,241,242,243,244],"Breast Carcinoma","Malignant Ovarian Neoplasm","Malignant Pancreatic Neoplasm","Prostate Carcinoma","Solid Neoplasm",[246],"TBCE wt Allele",{"nct_id":4,"found":248,"summary":249,"prompt_version":259},true,{"design":250,"status":251,"heading":252,"summary":253,"follow_up":254,"word_count":255,"commitments":256,"compensation":257,"drugs_mentioned":258},"This is a Phase 1, open-label study, meaning both you and your doctors will know which treatment you are receiving. It involves two groups: one receiving MOMA-313 alone and another receiving MOMA-313 with olaparib.","completed","Study of MOMA-313 for Advanced Solid Tumors","This study is testing a new oral medication called MOMA-313, alone or with another oral medication called olaparib, for people with advanced or metastatic (spread to other parts of the body) solid tumors, including prostate, pancreas, and breast cancer. The main goal is to understand the safety and side effects of MOMA-313. Researchers will also look at how the body handles the medicine and if it shows any early signs of helping against cancer. You may be able to join if you are 18 or older and have certain types of solid tumors that are considered \"HR-deficient\" (meaning they have a problem with DNA repair). This study is currently recruiting 220 participants.","Your safety will be monitored from the time you start screening until you stop treatment, which could be up to 35 months.",112,"Not specified in the trial record.","Not stated in the trial record.",[28,47],"v2"]