[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557155":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":40,"responsibleParty":451,"collaborators":453,"id":456,"slug":457,"hasResults":458,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":458,"sex":464,"minAge":465,"maxAge":33,"enrollmentInfo":466,"targetDuration":33,"studyType":469,"phases":470,"briefSummary":472,"conditions":473,"keywords":475,"overallStatus":43,"whyStopped":33,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":488},{"fullName":5,"class":6},"Ryvu Therapeutics SA","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"MEN1703 + glofitamab","EXPERIMENTAL","• Participants who are naïve to treatment with an anti-CD3xCD20 bispecific antibody (group 1) will be given MEN1703 orally at a dose of 150 mg daily for 7 days or 125 mg daily for 14 days, in 21-day cycles for a maximum of 12 cycles, in combination with glofitamab administered as an IV infusion in a step-up dosing schedule starting with 2.5 mg on day 8 of cycle 1, and10 mg on day 15 of cycle 1, and 30 mg on day 1 from cycle 2 onward until disease progression or withdrawal, for a maximum of 12 cycles (parts 1, 2, 3)).\n\nAll participants will be administered 1,000 mg of obinutuzumab as an IV infusion on cycle 1 day 1.\n\n• Participants who have exhausted all standard treatment options (group 2) will receive MEN1703 as a single-agent, at a dose of 125 mg orally every-day for 14 consecutive days in consecutive 21-day treatment cycles, until progressive disease (parts 1 and 2).",[13,14],"Drug: MEN1703","Drug: Glofitamab",{"label":16,"type":17,"description":18,"interventionNames":19},"Gofitamab","ACTIVE_COMPARATOR","Participants who are naïve to treatment with an anti-CD3xCD20 bispecific antibody (group 1) will receive glofitamab as a single-agent administered as an IV infusion in a step-up dosing schedule starting with 2.5 mg on day 8 of cycle 1, and10 mg on day 15 of cycle 1, and 30 mg on day 1 from cycle 2 onward until disease progression or withdrawal, for a maximum of 12 cycles (part 3).",[14],[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","MEN1703","MEN1703 (Dapolsertib hydrochloride) is a potent dual inhibitor of proviral integration site for Moloney murine leukemia virus (PIM) kinases and Fms-like tyrosine kinase 3 (FLT3).",[9],[27,28],"SEL24","Dapolsertib hydrochloride",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Glofitamab","Glofitamab is a bispecific monoclonal antibody that binds bivalently to CD20 expressed on the surface of B-cells and monovalently to CD3 in the T-cell receptor complex expressed on the surface of T-cells.",[16,9],null,[35],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Head of Clinical Operations","CONTACT","+48 123140200","clinicaltrials@ryvu.com",[41,58,69,81,93,105,117,129,143,154,166,177,189,201,213,221,233,244,256,268,277,291,303,312,320,332,342,350,362,374,385,398,409,420,431,440],{"facility":42,"status":43,"city":44,"state":33,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Centre Hospitalier Le Mans","RECRUITING","Le Mans","72037","France","FR",{"type":49,"coordinates":50},"Point",[51,52],0.20251,48.0021,{"lat":52,"lon":51},[55],{"name":56,"role":57,"phone":33,"phoneExt":33,"email":33},"Kamel Laribi, MD PhD","PRINCIPAL_INVESTIGATOR",{"facility":59,"status":43,"city":60,"state":33,"zip":33,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"CHU de Lille - Hôpital Claude Huriez","Lille",{"type":49,"coordinates":62},[63,64],3.05512,50.63391,{"lat":64,"lon":63},[67],{"name":68,"role":57,"phone":33,"phoneExt":33,"email":33},"Franck Morschhauser, Prof.",{"facility":70,"status":43,"city":71,"state":33,"zip":72,"country":46,"countryCode":47,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"CHU de Limoges - CHU Dupuytren","Limoges","87042",{"type":49,"coordinates":74},[75,76],1.24759,45.83362,{"lat":76,"lon":75},[79],{"name":80,"role":57,"phone":33,"phoneExt":33,"email":33},"Julie Abraham, MD PhD",{"facility":82,"status":43,"city":83,"state":33,"zip":84,"country":46,"countryCode":47,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Hospices Civils De Lyon - Hôpital Lyon Sud","Lyon","69310",{"type":49,"coordinates":86},[87,88],4.84789,45.74906,{"lat":88,"lon":87},[91],{"name":92,"role":57,"phone":33,"phoneExt":33,"email":33},"Herve Ghesquieres, Prof.",{"facility":94,"status":43,"city":95,"state":33,"zip":96,"country":46,"countryCode":47,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"CHU Montpellier - Hôpital Saint Eloi","Montpellier","34490",{"type":49,"coordinates":98},[99,100],3.87635,43.61093,{"lat":100,"lon":99},[103],{"name":104,"role":57,"phone":33,"phoneExt":33,"email":33},"Guillaume Cartron, MD PhD",{"facility":106,"status":43,"city":107,"state":33,"zip":108,"country":46,"countryCode":47,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"APHP - Hôpital Pitié-Salpêtrière","Paris","75651",{"type":49,"coordinates":110},[111,112],2.3488,48.85341,{"lat":112,"lon":111},[115],{"name":116,"role":57,"phone":33,"phoneExt":33,"email":33},"Sylvain Choquet, MD PhD",{"facility":118,"status":43,"city":119,"state":33,"zip":120,"country":46,"countryCode":47,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"CHU de Bordeaux - Hôpital Haut-Lévêque","Pessac","33600",{"type":49,"coordinates":122},[123,124],-0.6324,44.80565,{"lat":124,"lon":123},[127],{"name":128,"role":57,"phone":33,"phoneExt":33,"email":33},"Francois Xavier Gros, MD PhD",{"facility":130,"status":43,"city":131,"state":33,"zip":33,"country":132,"countryCode":133,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej","Biała Podlaska","Poland","PL",{"type":49,"coordinates":135},[136,137],23.11652,52.03238,{"lat":137,"lon":136},[140,142],{"name":141,"role":37,"phone":33,"phoneExt":33,"email":33},"Piotr Centkowski, MD PhD",{"name":141,"role":57,"phone":33,"phoneExt":33,"email":33},{"facility":144,"status":43,"city":145,"state":33,"zip":33,"country":132,"countryCode":133,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"IN-VIVO Bydgoszcz Sp. z o.o.","Bydgoszcz",{"type":49,"coordinates":147},[148,149],18.00762,53.1235,{"lat":149,"lon":148},[152],{"name":153,"role":57,"phone":33,"phoneExt":33,"email":33},"Jarosław Czyż, Prof.",{"facility":155,"status":156,"city":157,"state":33,"zip":33,"country":132,"countryCode":133,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Klinika Hematologii I Transplantologii Uck","NOT_YET_RECRUITING","Gdansk",{"type":49,"coordinates":159},[160,161],18.64912,54.35227,{"lat":161,"lon":160},[164],{"name":165,"role":57,"phone":33,"phoneExt":33,"email":33},"Jan Zaucha, Prof.",{"facility":167,"status":43,"city":168,"state":33,"zip":33,"country":132,"countryCode":133,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Szpitale Pomorskie Sp. z o.o.","Gdynia",{"type":49,"coordinates":170},[171,172],18.53188,54.51889,{"lat":172,"lon":171},[175],{"name":176,"role":57,"phone":33,"phoneExt":33,"email":33},"Adam Witkowski, MD PhD",{"facility":178,"status":43,"city":179,"state":33,"zip":33,"country":132,"countryCode":133,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie, Państwowy Instytut Badawczy","Gliwice",{"type":49,"coordinates":181},[182,183],18.67658,50.29761,{"lat":183,"lon":182},[186,188],{"name":187,"role":37,"phone":33,"phoneExt":33,"email":33},"Małgorzata Krawczyk-Kuliś, Prof.",{"name":187,"role":57,"phone":33,"phoneExt":33,"email":33},{"facility":190,"status":43,"city":191,"state":33,"zip":33,"country":132,"countryCode":133,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Pratia Hematologia Sp. z o.o.","Katowice",{"type":49,"coordinates":193},[194,195],19.02173,50.2597,{"lat":195,"lon":194},[198,200],{"name":199,"role":37,"phone":33,"phoneExt":33,"email":33},"Sebastian Grosicki, Prof.",{"name":199,"role":57,"phone":33,"phoneExt":33,"email":33},{"facility":202,"status":43,"city":203,"state":33,"zip":33,"country":132,"countryCode":133,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Pratia MCM Kraków","Krakow",{"type":49,"coordinates":205},[206,207],19.93658,50.06143,{"lat":207,"lon":206},[210,212],{"name":211,"role":37,"phone":33,"phoneExt":33,"email":33},"Wojciech Jurczak, Prof.",{"name":211,"role":57,"phone":33,"phoneExt":33,"email":33},{"facility":214,"status":156,"city":203,"state":33,"zip":33,"country":132,"countryCode":133,"cosmosGeoPoint":215,"geoPoint":217,"contacts":218},"SP ZOZ Szpital Uniwersytecki w Krakowie",{"type":49,"coordinates":216},[206,207],{"lat":207,"lon":206},[219],{"name":220,"role":57,"phone":33,"phoneExt":33,"email":33},"Agnieszka Giza, MD PhD",{"facility":222,"status":43,"city":223,"state":33,"zip":33,"country":132,"countryCode":133,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie","Olsztyn",{"type":49,"coordinates":225},[226,227],20.49272,53.78376,{"lat":227,"lon":226},[230,232],{"name":231,"role":37,"phone":33,"phoneExt":33,"email":33},"Janusz Hałka, MD PhD",{"name":231,"role":57,"phone":33,"phoneExt":33,"email":33},{"facility":234,"status":43,"city":235,"state":33,"zip":33,"country":132,"countryCode":133,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"Aidport Sp. z o.o.","Skórzewo",{"type":49,"coordinates":237},[238,239],17.81889,53.03629,{"lat":239,"lon":238},[242],{"name":243,"role":57,"phone":33,"phoneExt":33,"email":33},"Michał Kwiatek, Dr",{"facility":245,"status":43,"city":246,"state":33,"zip":33,"country":132,"countryCode":133,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu","Torun",{"type":49,"coordinates":248},[249,250],18.59814,53.01375,{"lat":250,"lon":249},[253,255],{"name":254,"role":37,"phone":33,"phoneExt":33,"email":33},"Dominik Chraniuk, MD",{"name":254,"role":57,"phone":33,"phoneExt":33,"email":33},{"facility":257,"status":43,"city":258,"state":33,"zip":33,"country":132,"countryCode":133,"cosmosGeoPoint":259,"geoPoint":263,"contacts":264},"Lux Med Onkologia Sp. z o.o.","Warsaw",{"type":49,"coordinates":260},[261,262],21.01178,52.22977,{"lat":262,"lon":261},[265,267],{"name":266,"role":37,"phone":33,"phoneExt":33,"email":33},"Joanna Barankiewicz, MD PhD",{"name":266,"role":57,"phone":33,"phoneExt":33,"email":33},{"facility":269,"status":43,"city":258,"state":33,"zip":33,"country":132,"countryCode":133,"cosmosGeoPoint":270,"geoPoint":272,"contacts":273},"Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy",{"type":49,"coordinates":271},[261,262],{"lat":262,"lon":261},[274,276],{"name":275,"role":37,"phone":33,"phoneExt":33,"email":33},"Krzysztof Gawroński, MD PhD",{"name":275,"role":57,"phone":33,"phoneExt":33,"email":33},{"facility":278,"status":43,"city":279,"state":33,"zip":280,"country":281,"countryCode":282,"cosmosGeoPoint":283,"geoPoint":287,"contacts":288},"Hospital Universitari Vall D Hebron","Barcelona","08035","Spain","ES",{"type":49,"coordinates":284},[285,286],2.15899,41.38879,{"lat":286,"lon":285},[289],{"name":290,"role":57,"phone":33,"phoneExt":33,"email":33},"Crisitna Garcia Herce, MD PhD",{"facility":292,"status":43,"city":293,"state":33,"zip":294,"country":281,"countryCode":282,"cosmosGeoPoint":295,"geoPoint":299,"contacts":300},"Clinica Universidad De Navarra","Madrid","28027",{"type":49,"coordinates":296},[297,298],-3.70256,40.4165,{"lat":298,"lon":297},[301],{"name":302,"role":57,"phone":33,"phoneExt":33,"email":33},"Miguel Angel Canales Albendea, MD PhD",{"facility":304,"status":43,"city":293,"state":33,"zip":305,"country":281,"countryCode":282,"cosmosGeoPoint":306,"geoPoint":308,"contacts":309},"MD Anderson Cancer Center","28033",{"type":49,"coordinates":307},[297,298],{"lat":298,"lon":297},[310],{"name":311,"role":57,"phone":33,"phoneExt":33,"email":33},"Adolfo De La Fuente Burguera, MD PhD",{"facility":313,"status":156,"city":293,"state":33,"zip":33,"country":281,"countryCode":282,"cosmosGeoPoint":314,"geoPoint":316,"contacts":317},"Hospital Universitario Puerta de Hierro Majadahonda",{"type":49,"coordinates":315},[297,298],{"lat":298,"lon":297},[318],{"name":319,"role":57,"phone":33,"phoneExt":33,"email":33},"Mariano Provencio Pulla, MD PhD",{"facility":321,"status":156,"city":322,"state":33,"zip":323,"country":281,"countryCode":282,"cosmosGeoPoint":324,"geoPoint":328,"contacts":329},"Hospital Clínico Uni versitario Virgen de la Arrixaca","Murcia","30120",{"type":49,"coordinates":325},[326,327],-1.13004,37.98704,{"lat":327,"lon":326},[330],{"name":331,"role":57,"phone":33,"phoneExt":33,"email":33},"Ignacio Espanol Morales, Dr",{"facility":292,"status":43,"city":333,"state":33,"zip":334,"country":281,"countryCode":282,"cosmosGeoPoint":335,"geoPoint":339,"contacts":340},"Pamplona","31008",{"type":49,"coordinates":336},[337,338],-1.64323,42.81687,{"lat":338,"lon":337},[341],{"name":302,"role":57,"phone":33,"phoneExt":33,"email":33},{"facility":343,"status":43,"city":333,"state":33,"zip":334,"country":281,"countryCode":282,"cosmosGeoPoint":344,"geoPoint":346,"contacts":347},"Hospital Universitario De Navarra",{"type":49,"coordinates":345},[337,338],{"lat":338,"lon":337},[348],{"name":349,"role":57,"phone":33,"phoneExt":33,"email":33},"Jose Maria Arguinano Perez, MD PhD",{"facility":351,"status":43,"city":352,"state":33,"zip":353,"country":281,"countryCode":282,"cosmosGeoPoint":354,"geoPoint":358,"contacts":359},"Hospital Universitario De Salamanca","Salamanca","37007",{"type":49,"coordinates":355},[356,357],-5.66388,40.96882,{"lat":357,"lon":356},[360],{"name":361,"role":57,"phone":33,"phoneExt":33,"email":33},"Norma Carmen Gutierrez, Prof.",{"facility":363,"status":43,"city":364,"state":33,"zip":365,"country":281,"countryCode":282,"cosmosGeoPoint":366,"geoPoint":370,"contacts":371},"Hospital Universitario Virgen De La Macarena","Seville","41009",{"type":49,"coordinates":367},[368,369],-5.97317,37.38283,{"lat":369,"lon":368},[372],{"name":373,"role":57,"phone":33,"phoneExt":33,"email":33},"Luis de la Cruz Merino, MD PhD",{"facility":375,"status":156,"city":376,"state":33,"zip":33,"country":281,"countryCode":282,"cosmosGeoPoint":377,"geoPoint":381,"contacts":382},"Hospital Universitario Miguel Servet","Zaragoza",{"type":49,"coordinates":378},[379,380],-0.87734,41.65606,{"lat":380,"lon":379},[383],{"name":384,"role":57,"phone":33,"phoneExt":33,"email":33},"Araceli Rubio Martinez, MD PhD",{"facility":386,"status":43,"city":387,"state":33,"zip":33,"country":388,"countryCode":389,"cosmosGeoPoint":390,"geoPoint":394,"contacts":395},"Beatson West of Scotland Cancer Centre","Glasgow","United Kingdom","UK",{"type":49,"coordinates":391},[392,393],-4.25763,55.86515,{"lat":393,"lon":392},[396],{"name":397,"role":57,"phone":33,"phoneExt":33,"email":33},"Mark Rafferty, Dr",{"facility":399,"status":156,"city":400,"state":33,"zip":33,"country":388,"countryCode":389,"cosmosGeoPoint":401,"geoPoint":405,"contacts":406},"The Royal Marsden Hospital","London",{"type":49,"coordinates":402},[403,404],-0.12574,51.50853,{"lat":404,"lon":403},[407],{"name":408,"role":57,"phone":33,"phoneExt":33,"email":33},"David Cunningham, Dr",{"facility":410,"status":43,"city":411,"state":33,"zip":33,"country":388,"countryCode":389,"cosmosGeoPoint":412,"geoPoint":416,"contacts":417},"The Christie NHS Foundation Trust","Manchester",{"type":49,"coordinates":413},[414,415],-2.23743,53.48095,{"lat":415,"lon":414},[418],{"name":419,"role":57,"phone":33,"phoneExt":33,"email":33},"Kim Linton, Dr",{"facility":421,"status":43,"city":422,"state":33,"zip":33,"country":388,"countryCode":389,"cosmosGeoPoint":423,"geoPoint":427,"contacts":428},"Plymouth Hospitals NHS Trust","Plymouth",{"type":49,"coordinates":424},[425,426],-4.14305,50.37153,{"lat":426,"lon":425},[429],{"name":430,"role":57,"phone":33,"phoneExt":33,"email":33},"David Burns, Dr",{"facility":399,"status":156,"city":432,"state":33,"zip":33,"country":388,"countryCode":389,"cosmosGeoPoint":433,"geoPoint":437,"contacts":438},"Sutton",{"type":49,"coordinates":434},[435,436],-0.2,51.35,{"lat":436,"lon":435},[439],{"name":408,"role":57,"phone":33,"phoneExt":33,"email":33},{"facility":441,"status":43,"city":442,"state":33,"zip":33,"country":388,"countryCode":389,"cosmosGeoPoint":443,"geoPoint":447,"contacts":448},"St George's Hospital","Tooting",{"type":49,"coordinates":444},[445,446],-0.16394,51.42524,{"lat":446,"lon":445},[449],{"name":450,"role":57,"phone":33,"phoneExt":33,"email":33},"Ruth Pettengell, Dr",{"type":452,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[454],{"name":455,"class":6},"Menarini Group","100557155","phase-2-men1703-sel24-to-treat-relapsed-or-refractory-aggressive-b-cell-non-hodgkin-lymphoma-jaspis-01-100557155",false,"NCT06534437","MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)","An Open Label, Phase 2 Clinical Trial of MEN1703 as Monotherapy and in Combination With Glofitamab in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma","JASPIS-01","Inclusion Criteria:\n\n1. Age ≥18 years old\n2. Documented histological confirmation of aggressive B-cell non-Hodgkin lymphoma including DLBCL NOS and transformed indolent B-cell lymphoma\n3. Relapsed or refractory disease having received at least 2 prior lines of systemic treatment and, naïve to anti-CD3xCD20 bispecific antibody treatment (group 1) or exhausted all standard, available treatment options (group 2)\n4. At least 1 measurable site of disease based on computed tomography (CT) or positron emission tomography (PET)-CT scan with involvement of 2 or more clearly demarcated lesions and or nodes.\n5. Availability of lymph node tissue at Screening (or archival sample) (part 2 participants only)\n6. Life expectancy of ≥12 weeks.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2\n8. Adequate organ function at Screening\n9. Adequate hematologic function\n\nExclusion Criteria:\n\n1. Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening.\n2. Received anti-cancer treatments, including cytotoxic chemotherapy, radiotherapy, hormonal therapy, biologic, immunotherapy, or investigational drugs within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug. Prior treatment with CAR-T cell or an anti-CD3xCD20 bispecific antibody therapy (permitted for Group 2 only), requires a wash out period of ≥4 weeks.\n3. Concurrent participation in another therapeutic clinical study.\n4. Ongoing clinically significant toxicity (for example, alopecia is not clinically significant) from any prior anti-cancer therapy that has not resolved to Grade 1 or less prior to the first dose of study drug.\n5. Prior treatment with a PIM inhibitor.\n6. Group 1 only: Any prior therapy with a bispecific antibody targeting CD3 and CD20.\n7. Known risk of allergy to the study drugs, MEN1703 (group 1 and 2) or glofitamab (group 1) or their excipients\n8. Contraindication to all uric acid lowering agents.\n9. Major surgery within 1 month prior to first dose of study drug.\n10. Hematopoietic stem cell transplant within 4 months prior to first dose of study drug.\n11. Requires systemic immune-modulating therapy (regardless of dose) or has confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression.\n12. Exposed to live or live attenuated vaccine(s) within 4 weeks prior to signing the informed consent form (ICF).\n13. Evidence of ongoing and uncontrolled systemic bacterial, fungal, or viral infection, except for documented Grade Common Terminology Criteria for Adverse Events (CTCAE) ≤2 infections with evidence of improvement or without evidence of worsening infection.\n14. Known human immunodeficiency virus (HIV) infection\n15. Current active liver disease from any cause\n16. Ongoing drug-induced pneumonitis.\n17. Ongoing inflammatory bowel disease.\n18. Active known second malignancy\n19. Received an agent known to be a sensitive CYP2D6 substrate or a CYP2D6 substrate with a narrow therapeutic range, a strong or moderate CYP2D6 inhibitor, or a BCRP inhibitor within 14 days or 5 half-lives (whichever is shorter), prior to the first dose of study drug.\n20. Cardiac dysfunction is defined as myocardial infarction within 6 months of study entry, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled dysrhythmias, or poorly controlled angina.\n21. Receiving treatment for active, ongoing thromboembolic event. Note: Does not apply to prophylactic treatment to prevent or avoid reoccurrence of a prior resolved event. To review with Medical Monitor where further risk assessment is needed.\n22. History of serious ventricular arrhythmia (e.g., VT or VF, ≥3 beats in a row), or QT interval corrected for heart rate (QTc) ≥480 ms.\n\n    Note: QTc values up to 500 ms will be acceptable where patient's medical history e.g., bundle branch block, is known to cause mild QTc prolongation and the condition is well controlled.\n23. Any disease, syndrome or condition which may significantly affect drug intake via oral route.\n24. Planning to become pregnant or breastfeed during treatment and for 1 month after the last dose of study drug.\n25. Any other prior or current medical condition, intercurrent illness, surgical history, physical or 12-lead electrocardiogram (ECG) findings, laboratory abnormalities, or extenuating circumstance (e.g., alcohol or drug addiction) that, in the investigator's opinion, could jeopardize patient safety or interfere with the objectives of the study.","ALL","18 Years",{"count":467,"type":468},178,"ESTIMATED","INTERVENTIONAL",[471],"PHASE2","The goal of the study is to assess the safety and anti-lymphoma activity of MEN1703 (Dapolsertib hydrochloride) when given as a single-agent or combined with glofitamab to patients with relapsed\u002Frefractory (R\u002FR) aggressive B-cell non-Hodgkin lymphoma. The study will be open to groups at the same time:\n\n* Group 1 - patients who have not had anti-CD3xCD20 bispecific antibody therapy but who have had at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma\n* Group 2 - patients who have exhausted all standard treatment options including at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma Group 1 patients will be treated for a maximum of 12 cycles. One cycle is 21 days. Group 2 with be treated until the disease progresses, therefore treatment duration is dependent on the number of treatment cycles a participant receives prior to progression.",[474],"Non-Hodgkin Lymphoma, B-cell",[476,477,478],"Relapsed","Refractory","Aggressive","2025-09-23",{"date":481,"type":482},"2025-09-29","ACTUAL",{"date":484,"type":482},"2024-12-05",{"date":486,"type":468},"2026-12",{"name":5,"class":6},36]