[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Genmab\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":353},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,41,65,103,125,145,168,189,211,233,272,319],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100634409","phase-2-study-to-assess-the-efficacy-and-safety-of-rina-s-in-participants-with-advanced-gastrointestinal-gi-cancers-100634409",false,"NCT07539311","Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers","A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers","RAINFOL-09","Key Inclusion Criteria:\n\n• All study cohorts\n\n* Participant has histologically or cytologically confirmed GI cancer.\n* Participant has documented metastatic or unresectable disease, not amenable to treatment with curative intent.\n* Participant has measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at baseline.\n* Participant must have radiological disease progression while on or after receiving the most recent regimen.\n* Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participant has life expectancy ≥3 months.\n* Participant must be able to provide a newly obtained or archival tissue sample.\n* Participant must have adequate organ and bone marrow function, per laboratory test results prior to Rina-S administration.\n\nKey Exclusion Criteria (all study cohorts):\n\n* Participant has clinically significant non-malignant gastrointestinal disorders, including but not limited to, diarrhea \\> grade 1, ulcerative colitis, inflammatory bowel disease.\n* Participants with recent (up to 4 weeks) history of significant gastrointestinal bleeding, current cancer related ulcerations, fistula, abscess or recent perforation (within 4 to 6 weeks).\n* Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy.\n* Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease).\n* Prior treatment with topoisomerase-1 inhibitor containing antibody-drug conjugate (ADC).\n* Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This Phase 2 study will be conducted in different countries around the world with up to about 160 participants.\n\nThe purpose of this study is to evaluate how well Rina-S works against GI cancers.\n\nThe medication in this study is Rina-S monotherapy (by itself; no other cancer treatments). All participants will receive active drug; no one will be given placebo.\n\nParticipation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging\u002FX-rays) to monitor whether the study treatment is safe and effective.\n\nThe duration of the study will be different for every participant, but an average study duration of 22 months is expected for participants. This will include a treatment period (expected to last an average of 12 months), plus data collection periods before and after treatment. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of an individual cycle is 21 days). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.",[27],"Gastrointestinal Cancers","RECRUITING","2026-06-19",{"date":31,"type":32},"2026-06-23","ACTUAL",{"date":34,"type":32},"2026-05-11",{"date":36,"type":21},"2028-11",{"name":38,"class":39},"Genmab","INDUSTRY",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100624937","phase-1-a-study-of-gen1106-in-participants-with-solid-tumors-100624937","NCT07416123","A Study of GEN1106 in Participants With Solid Tumors","First-In-Human, Open-Label, Dose Escalation and Expansion Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of GEN1106 in Participants With Solid Tumors","Key Inclusion Criteria:\n\n* Have progressed on or after standard of care (SoC) therapy, which should include chemotherapy, anti-programmed cell death protein 1 (PD-1)\u002Fprogrammed cell death ligand 1 (PD-L1) therapies, and enfortumab vedotin (EV), if applicable for the tumor type, or for whom there is no available standard therapy likely to provide clinical benefit, and for whom experimental therapy with GEN1106 may be beneficial, in the opinion of the investigator.\n* Have measurable disease according to RECIST v1.1.\n* Have Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1 at screening.\n* Part 1: Have histologically or cytologically confirmed diagnosis of cancer as specified per protocol.\n* Parts 2 and 3: Have histologically or cytologically confirmed diagnosis of metastatic urothelial carcinoma (mUC).\n\nKey Exclusion Criteria:\n\n* Prior treatment with topoisomerase 1 inhibitor-based antibody-drug conjugate (ADC) therapy.\n* Treatment with an anticancer agent within 4 weeks or for systemic therapies within 5 half-lives of the drug, whichever is shorter, prior to trial treatment administration.\n* Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to grade 1 or lower, except for alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy must have recovered to grade 2.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.",{"count":49,"type":21},103,[51],"PHASE1","The purpose of this trial is to learn about the safety and effectiveness of GEN1106 when it is used for the treatment of participants with certain types of cancer.\n\nThe trial has multiple parts. The first part of the trial tests different doses of GEN1106 to find out if it is safe and determine what are the best doses to use. The second and third parts continues to test the safety of and how well GEN1106 works in additional participants with a specific cancer type and at doses chosen based on results from the first part of the trial.\n\nFor each participant, the trial will last approximately 17 months but will vary for each person. This includes up to 21 days for screening prior to receiving trial treatment, approximately 5 months of treatment (the duration of treatment may vary for each participant), and approximately 11 months of follow up after trial treatment ends (the duration of follow up may vary for each participant).\n\nParticipation in the trial will require visits to the site, with more frequent visits during the first 6 weeks of treatment and then less frequent visits afterwards. At site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, computed tomography \\[CT\\] scans) to monitor whether the treatment is safe and effective.\n\nAll participants will receive active drug; no one will be given placebo.",[54,55],"Solid Tumors","Urothelial Carcinoma","2026-06-12",{"date":58,"type":32},"2026-06-15",{"date":60,"type":32},"2026-04-14",{"date":62,"type":21},"2029-06-25",{"name":38,"class":39},8,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":73,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100639689","phase-3-an-extension-study-to-assess-the-efficacy-of-rina-s-compared-to-treatment-of-investigators-choice-in-participants-with-platinum-resistant-ovarian-cancer-in-china-100639689","NCT07604766","An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China","A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer","RAINFOL-02","Key Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n* Participants may be enrolled regardless of FRα expression level.\n* Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.\n* Participants must have received prior treatment with the following therapies:\n\n  * Platinum chemotherapy\n  * Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the participant is not eligible for treatment with bevacizumab (or biosimilar) due to precautions\u002Fintolerance\n  * Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment unless the participant is not eligible for treatment with PARP inhibitor\n* Mirvetuximab soravtansine, if:\n\n  * Mirvetuximab soravtansine is available in the enrollment region, and\n  * The participant is eligible, and\n  * The participant does not have a documented medical exception, including chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment\u002Fmonitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and \u002For monocular vision.\n* Participants must have platinum-resistant disease:\n\n  * Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of adjuvant platinum-based therapy, and then progressed between \\> 91 days and ≤ 183 days after the date of the last dose of platinum.\n  * Participants who have received a protocol defined number of lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum.\n\nKey Exclusion Criteria:\n\n* Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.\n* Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen.\n* History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer.\n* Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) of the brain prior to study entry.\n* Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.\n* Participant has clinically significant ascites\u002Fpleural effusion. Enrollment of participants with an indwelling catheter flush\u002Fdrain is not allowed. Note: Clinically significant is defined as (1) symptomatic, or (2) requires therapeutic paracentesis\u002Fthoracentesis within 8 weeks of the first dose, or (3) recurrent ascites\u002Fpleural effusion that necessitates multiple paracentesis\u002Fthoracocentesis procedures more often than approximately every 4 weeks.\n\nNOTE: Other protocol-defined Inclusion\u002FExclusion criteria may apply.","FEMALE",{"count":75,"type":21},82,[77],"PHASE3","The purpose of this Chinese extension study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer.\n\nTreatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose.\n\nAll participants will receive active drug; no one will be given placebo.\n\nThis study is an extension study of the protocol GCT1184-02 (NCT06619236).",[80],"Platinum-resistant Ovarian Cancer",[82,83,84,85,86,87,88,89,90,91,92],"antibody-drug conjugate","folate receptor alpha (FRα)","ovarian cancer","fallopian tube cancer","primary peritoneal cancer","folate receptor","platinum-resistant ovarian cancer (PROC)","rinatabart sesutecan","Topoisomerase 1 inhibitor","PRO1184","GEN1184","NOT_YET_RECRUITING","2026-06-01",{"date":96,"type":32},"2026-06-02",{"date":98,"type":21},"2026-06",{"date":100,"type":21},"2028-12",{"name":38,"class":39},20,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":73,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100636319","phase-3-study-to-assess-the-efficacy-and-safety-of-rina-s-with-or-without-bevacizumab-compared-to-investigators-choice-of-platinum-based-chemotherapy-with-or-without-bevacizumab-as-second-line-treatment-in-participants-with-recurrent-platinum-sensitive-ovarian-cancer-100636319","NCT07564141","Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer","A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer","RAINFOL™-07","Key Inclusion Criteria:\n\n* Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer.\n* Participant must have documented recurrence or progression after first-line (1L) platinum-based chemotherapy regimen (carboplatin + paclitaxel ≥ 4 cycles) with or without bevacizumab and have platinum-sensitive disease defined as radiographic progression at least 6 months (ie, \\>183 days) after their last dose administration of platinum-based therapy.\n* Prior poly (ADP-ribose) polymerase inhibitor(s) (PARPi) maintenance therapy (alone or in combination with bevacizumab) is required for participants with breast cancer susceptibility gene (BRCA 1- and BRCA 2)-mutated (germline or somatic) or homologous recombination deficiency (HRD)-positive disease.\n* Participants must have measurable disease per RECIST v1.1 by investigator at baseline.\n* All participants must provide a tumor specimen.\n* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at baseline.\n\nKey Exclusion Criteria:\n\n* Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade\u002Fborderline ovarian tumors.\n* Participant has received previous therapy with other anti-angiogenetic agents different from bevacizumab or biosimilar.\n* Participant has received prior therapy with an antibody-drug conjugate (ADC) containing a topoisomerase-1 inhibitor.\n* Participant has received prior therapy with an ADC targeting folate receptor alpha (FRα).\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.",{"count":112,"type":21},688,[77],"This Phase 3 study will be conducted in different countries around the world with up to about 688 participants.\n\nThe purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with or without bevacizumab and how it compares to an investigator's choice of platinum-based chemotherapy with or without bevacizumab.\n\nParticipants will receive either:\n\n* Rina-S monotherapy (by itself),\n* Rina-S plus bevacizumab,\n* investigator's choice chemotherapy (by itself) (standard of care), or\n* investigator's choice chemotherapy plus bevacizumab (standard of care).\n\nNo participants will be given placebo. Participants will participate in 1 of 2 arms.\n\nThe treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.\n\nParticipants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 or 4 weeks, depending on medication received). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective.\n\nThe overall study duration (including screening, treatment, and follow-up) will be different for every participant.",[116,117],"Platinum-Sensitive Ovarian Cancer","Ovarian Cancer",{"date":119,"type":32},"2026-06-03",{"date":121,"type":21},"2026-07",{"date":123,"type":21},"2031-11",{"name":38,"class":39},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},"100622703","phase-1-trial-to-evaluate-the-safety-and-preliminary-efficacy-of-gen1079-in-participants-with-advanced-solid-tumors-100622703","NCT07387068","Trial to Evaluate the Safety and Preliminary Efficacy of GEN1079 in Participants With Advanced Solid Tumors","First-in-human, Open-label, Phase 1 Trial to Evaluate the Safety and Preliminary Efficacy of GEN1079 in Participants With Select Advanced Malignant Solid Tumors","Key Inclusion Criteria:\n\nAll Parts:\n\n* Must have histologically confirmed selected solid cancers.\n* Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The measurable lesion(s) must be outside the field of prior radiation therapy unless there is documented progression in the lesion(s).\n* Must provide formalin-fixed paraffin-embedded tumor tissue (aspirates and bone specimens are not acceptable), archival or fresh, collected after discontinuation of their most recent anticancer treatment and prior to the first administration of GEN1079. If an archival specimen is unavailable, a procedure for obtaining a fresh tumor biopsy must be performed, provided it is performed according to standard of care and is deemed safe by the investigator.\n* Has acceptable laboratory test results prior to trial treatment administration, including platelet count \\>150×10\\^9\u002Flitre (L).\n\nParts 1 and 2:\n\n* Have histologically confirmed selected solid cancers that are metastatic or unresectable.\n* Prior protocol defined therapy is permitted, with no restrictions on the number of prior lines of therapy received or the time since the most recent therapy.\n\nPart 3:\n\n* Have histologically confirmed selected solid cancer that is metastatic or unresectable.\n* Must have received a defined number of prior lines of a protocol defined regimen.\n\nKey Exclusion Criteria:\n\n* Has intercurrent illness or known history of any of the following that could affect compliance with the protocol or interpretation of the results, including but not limited to:\n\n  * Autoimmune diseases, eg, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), neuromyelitis optica (NMO), myasthenia gravis (MG), cold agglutinin disease (CAD), atypical hemolytic uremic syndrome (aHUS), immunoglobulin A (IgA) nephropathy, inflammatory bowel disease (IBD; Crohn's and ulcerative colitis).\n  * Grade ≥3 allergic reactions to prior monoclonal antibody therapy.\n  * Known history of interstitial lung disease (ILD) Grade ≥3 or prior or ongoing noninfectious pneumonitis with evidence of progressive fibrotic changes on baseline imaging, unless clinically and radiologically stable for ≥6 months with preserved pulmonary function (eg, diffusing capacity of the lungs for carbon monoxide \\[DLCO\\] ≥ 50% predicted).\n  * Disorders associated with platelet function defects, decreased number of platelets (eg, splenomegaly, chronic liver disease or bleeding disorders such as hemophilia or Von Willebrand disease), or a known history or high risk of bleeding events requiring transfusions or hospitalizations.\n* Treatment with any plasma-based therapy within 7 days prior to Cycle 1 Day 1.\n* Any history of intracerebral arteriovenous malformation (shunts), cerebral aneurysm, spinal cord compression (from disease), carcinomatous meningitis, or stroke. Note: Transient ischemic attack \\>1 month prior to screening is allowed.\n* Participants who, in the event of a medical complication during the trial treatment period, would be unable to temporarily discontinue and restart anticoagulant\u002Fantiplatelet therapy using appropriate bridging strategies (eg, low molecular weight heparin) in alignment with local standard of care.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.",{"count":133,"type":21},121,[51],"The purpose of this trial is to learn about the safety and effectiveness of the antibody GEN1079 in participants with certain types of cancer.\n\nThe trial has multiple parts. The first part of the trial tests different doses of GEN1079 to find out if it is safe and determine what are the best doses to use. The second and third parts continue to test the safety of and whether GEN1079 works in additional participants with specific cancer types and at doses chosen based on results from the previous parts of the trial.\n\nFor each participant, the trial will last approximately 33 to 67 weeks but this may vary for each person. This includes up to 21 days for screening prior to receiving trial treatment, approximately 6 to 12 weeks of treatment (the duration of treatment may vary for each participant), and approximately 24 to 52 weeks of follow up after trial treatment ends (the duration of follow up may vary for each participant). During the screening, tumor tissue either collected prior to this trial or freshly collected during screening will be provided by all participants.\n\nParticipation in the trial will require visits to the site, with more frequent visits at the start of treatment and then less frequent visits afterwards. At site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, computed tomography \\[CT\\] scans) to monitor whether the treatment is safe and effective.\n\nAll participants will receive active drug; no one will be given placebo.",[137],"Advanced Solid Tumors",{"date":96,"type":32},{"date":140,"type":32},"2026-04-07",{"date":142,"type":21},"2031-01",{"name":38,"class":39},11,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100622522","phase-1-first-in-human-fih-trial-of-gen3018-in-relapsed-or-refractory-rr-acute-myeloid-leukemia-aml-or-higher-risk-myelodysplastic-syndrome-hr-mds-100622522","NCT07384715","First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R\u002FR) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)","An Open-Label, Multicenter, First-in-Human Trial of GEN3018 in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome","Key Inclusion Criteria:\n\nAll Participants:\n\n* Be at least 18 years of age at the time of signing informed consent form (ICF).\n* Participant's life expectancy at screening is judged to be at least 3 months.\n* Must have fresh bone marrow samples collected at screening.\n* Bone marrow (BM) blasts ≥ 5% at screening.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2.\n* Has acceptable laboratory test results during the screening period\n\nParticipants with R\u002FR AML:\n\n* Relapsed or refractory AML, either de novo or secondary, and must have failed all conventional therapies.\n* Relapsed or refractory to at least one prior line of therapy.\n\nParticipants with R\u002FR HR-MDS:\n\n* Diagnosed with high- or very-high risk MDS according to International Prognostic Scoring System (IPSS-R) (score of \\> 4.5 ie, high or very high) or World Health Organization (WHO) 2022 classification (ie, MDS-IB1 or MDS-IB2).\n* Refractory or relapsed after hypomethylating agents (HMAs) (such as azacitidine or decitabine).\n\nKey Exclusion Criteria:\n\nAll Participants:\n\n* Diagnosis of acute promyelocytic leukemia (APL).\n* Presence of extramedullary AML at screening.\n* Prior autologous or allogenic hematopoietic stem cell transplant (HSCT) within 3 months prior to initiation of trial treatment.\n* Active graft-versus-host disease.\n* History of severe immune-related adverse events.\n* Treatment with anti-cancer agent (eg, small molecule, antibody, chemotherapy, radiation therapy), or major surgery within 2 weeks prior to the first dose of GEN3018.\n\nOther protocol-defined Inclusion and Exclusion criteria may apply.",{"count":153,"type":21},78,[51],"The drug that will be investigated in the trial is an antibody, GEN3018. Since this is the first trial of GEN3018 in humans, the main purpose is to evaluate safety. In addition to safety, the trial will determine the recommended GEN3018 dose(s) to be tested in a larger group of participants and assess preliminary anti-tumor activity of GEN3018. GEN3018 will be studied in refractory (resistant to treatment) or relapsed (disease has returned) acute myeloid leukemia (also known as R\u002FR AML) and refractory or relapsed higher-risk myelodysplastic syndrome (also known as R\u002FR HR-MDS). The trial consists of 2 parts:\n\n1. Part 1 Dose Escalation will test increasing doses of GEN3018 to identify a safe dose level to be tested in the next part\n2. Part 2 Dose Refinement will further test the GEN3018 dose(s) determined from the Dose Escalation.\n\nUp to 78 participants may be treated in this trial (up to 60 participants in Part 1; up to 18 participants in Part 2).\n\nFor an individual participant in the trial, the estimated treatment duration will be up to 1 year. Participation in the trial will require regular scheduled visits to the site. At site visits, there will be various tests (such as blood draws) to monitor whether the treatment is safe and effective. Participants will also be contacted every 3 months after treatment ends to monitor how they are doing.\n\nAll participants in the trial will receive active drug (ie, GEN3018); no one will be given placebo.",[157,158,159,160],"R\u002FR AML","R\u002FR HR-MDS","Acute Myeloid Leukemia","Higher-Risk Myelodysplastic Syndrome",{"date":96,"type":32},{"date":163,"type":32},"2026-02-16",{"date":165,"type":21},"2030-04-20",{"name":38,"class":39},9,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},"100615097","phase-2-study-to-assess-the-efficacy-and-safety-of-rina-s-in-participants-with-non-small-cell-lung-cancer-100615097","NCT07288177","Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer","A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer","RAINFOL-05","Key Inclusion Criteria:\n\n* Participant has histologically or cytologically confirmed metastatic or locally advanced NSCLC of adenocarcinoma histology, not amenable to curative surgery or radiotherapy.\n* Participant must have radiological disease progression while on or after receiving the most recent regimen.\n* Participants either may have actionable genetic alterations (AGAs) or no AGAs.\n* Participant has measurable disease according to RECIST v1.1.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 within 7 days of Cycle 1 Day 1.\n\nKey Exclusion Criteria (all study cohorts):\n\n* Participant has NSCLC with histology other than adenocarcinoma\n* Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year OS ≥ 90%), including, but not limited to, adequately treated cervical carcinoma of stage 1B or less, in situ basal cell or squamous cell skin carcinoma, in situ bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥ 3 years.\n* Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease). Participants with history of spinal cord compression (from disease). Participants with previous CNS-directed therapy (eg, radiotherapy and\u002For surgery) for brain metastases may participate provided lesion(s) are radiologically stable (ie, without evidence of progression) for at least 28 days by repeat imaging.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.",{"count":177,"type":21},240,[24],"This Phase 2 study will be conducted in different countries around the world with up to about 240 participants.\n\nThe purpose of this study is to evaluate how well Rina-S works against lung cancer.\n\nThe treatment in this study is Rina-S monotherapy (by itself). All participants will receive active drug; no one will be given placebo.\n\nThe treatment duration will be different for every participant, but an average of 12 months is expected. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of cycle is 3 weeks). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.\n\nParticipation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging\u002FX-rays) to monitor whether the study treatment is safe and effective.",[181],"Non-small Cell Lung Cancer (NSCLC)",{"date":96,"type":32},{"date":184,"type":32},"2026-01-30",{"date":186,"type":21},"2028-11-22",{"name":38,"class":39},22,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},"100610260","phase-3-study-to-assess-the-efficacy-and-safety-of-rina-s-plus-standard-of-care-compared-to-standard-of-care-for-maintenance-treatment-of-participants-with-recurrent-platinum-sensitive-ovarian-cancer-after-second-line-2l-platinum-based-doublet-chemotherapy-100610260","NCT07225270","Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Recurrent Platinum-sensitive Ovarian Cancer After Second-line (2L) Platinum-based Doublet Chemotherapy","A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L Platinum-Based Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)","RAINFOL-04","Key Inclusion Criteria:\n\n* Must have histologically or cytologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.\n* Must have PSOC defined as progressive disease \\> 6 months (ie, 183 days) from the last dose of primary (first-line \\[1L\\]) platinum therapy.\n* Participants with known breast cancer (BRCA)-mutated (somatic or germline) or homologous recombination deficiency (HRD)-positive ovarian cancer who achieved complete response (CR)\u002Fno clinical evidence of disease (NED) or partial response (PR) following 1L platinum-based chemotherapy regimen must have previously received PARPi maintenance therapy as part of their 1L treatment.\n* Must have completed platinum-based chemotherapy in the 2L treatment for recurrent PSOC.\n* Must be randomized no later than 8 weeks from the last dose of the 2L platinum-based therapy.\n* Participants must have achieved a CR\u002FNED, PR; or SD permitted only if bevacizumab was given in 2L in combination with platinum-based chemotherapy, as assessed by the investigator, following completion of 2L platinum-based chemotherapy.\n\nKey Exclusion Criteria:\n\n* Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade\u002Fborderline ovarian tumors\n* More than 2 prior lines of systemic therapy.\n* Progression while on or following 2L platinum-based regimen prior to randomization.\n* Participants who receive an intervening systemic anticancer treatment (excluding bevacizumab) after the last dose of 2L platinum-based chemotherapy and prior to randomization.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.",{"count":198,"type":21},528,[77],"This Phase 3 study will be conducted in different countries around the world with up to about 528 participants.\n\nThe purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with available standard of care therapy that is already approved and used for ovarian cancer.\n\nParticipants will receive either Rina-S monotherapy (by itself), Rina-S plus bevacizumab, bevacizumab (standard of care) by itself, or no treatment (only monitoring, also standard of care). No participants will be given placebo. Participants will participate in 1 of 2 arms.\n\nThe treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.\n\nParticipants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) for each participant will be different for every participant.",[117,202,203],"Platinum-sensitive Ovarian Cancer","PSOC",{"date":96,"type":32},{"date":206,"type":32},"2026-04-03",{"date":208,"type":21},"2030-04",{"name":38,"class":39},13,{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":73,"minAge":18,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},"100605713","phase-3-study-to-assess-the-efficacy-and-safety-of-rina-s-compared-to-treatment-of-investigators-choice-in-participants-with-endometrial-cancer-100605713","NCT07166094","Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer","A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy","RAINFOL-03","Key Inclusion Criteria\n\n* Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.\n* Participants must have received at least 1, but not more than 3, prior lines of therapy:\n\n  * Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination\n  * If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, additional platinum-based chemotherapy must be administered for recurrent disease unless the participant is ineligible for further platinum-based chemotherapy, in which case the reason for ineligibility must be documented.\n\n    * Note: If Immunotherapy-based treatment is administered in the advanced\u002Frecurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from prior platinum-based chemotherapy. In such cases, the reason for ineligibility for platinum-based chemotherapy must be documented.\n  * Prior induction plus maintenance is considered 1 line of therapy\n  * Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.\n  * Therapy changed due to toxicity in the absence of progression will be considered part of the same line of therapy (i.e., will not be counted independently as a separate line of therapy)\n* Participants must have progressed radiographically on or after their most recent line of therapy\n\nKey Exclusion Criteria\n\n* Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.\n* Has a past or current malignancy other than the inclusion diagnosis before the planned first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated cervical carcinoma of Stage 1B or less, noninvasive basal cell or squamous cell skin carcinoma, noninvasive superficial bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥3 years (i.e., eligible participants must have complete response of ≥3 years duration).\n* Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after completion of brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the planned first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) of the brain prior to study entry.\n* Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.",{"count":220,"type":21},660,[77],"The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study.\n\nThe study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected.\n\nAll participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).",[224,225],"Endometrial Cancer","Recurrent or Progressive Endometrial Cancer",{"date":96,"type":32},{"date":228,"type":32},"2025-11-28",{"date":230,"type":21},"2029-11",{"name":38,"class":39},81,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},"100530819","phase-3-study-of-subcutaneous-epcoritamab-in-combination-with-intravenous-rituximab-and-oral-lenalidomide-r2-to-assess-adverse-events-and-change-in-disease-activity-in-adult-participants-with-previously-untreated-follicular-lymphoma-100530819","NCT06191744","Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma","A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)","EPCORE™FL-2","Inclusion Criteria:\n\n* Diagnosis of follicular lymphoma (FL).\n* Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.\n* Are willing and able to comply with procedures required in the protocol.\n* Must have stage, III, IV or II with bulky disease \\>= 7cm).\n* Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.\n* Has one or more target lesions:\n\n  * A positron emission tomography (PET)\u002Fcomputerized tomography (CT) scan demonstrating PET-positive lesion(s), and\n  * \\>=1 measurable nodal lesion (long axis \\>1.5cm) or \\>=1 measurable extra-nodal lesion (long axis \\>1.0 cm) on CT scan or MRI\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: \\[Arm B\\] at the discretion of the Investigator, and rituximab and lenalidomide (R2) \\[Arm C\\].\n* Have laboratory values meeting the criteria in the protocol.\n\nExclusion Criteria:\n\n* Had major surgery within 4 weeks prior to randomization.\n* Have active cytomegalovirus (CMV) disease.",{"count":242,"type":21},1095,[77],"Follicular lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with previously untreated FL. Adverse events and change in disease condition will be assessed.\n\nEpcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 5 groups, called treatment arms. Each group receives a different treatment. Around 1095 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world.\n\nParticipants will receive R2 (intravenous \\[IV\\] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) \\[G-CHOP\\]\u002F R-CHOP or G and IV infusion of bendamustine (Benda) \\[G-Benda\\]\u002FR-Benda. The total treatment duration will be 120 weeks for all arms except A2, which is 24 weeks of treatment.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[246],"Follicular Lymphoma (FL)",[246,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,239],"Non-Hodgkin's lymphoma (NHL)","Lymphoma","Cancer","Epcoritamab","Rituximab","Lenalidomide","Chemoimmunotherapy (CIT)","Obinutuzumab","Cyclophosphamide","Doxorubicin Hydrochloride","Vincristine Sulfate","Prednisone","Bendamustine (Benda)","R-CHOP","G-CHOP","R-Benda","G-Benda",{"date":96,"type":32},{"date":267,"type":32},"2024-02-05",{"date":269,"type":21},"2037-11",{"name":38,"class":39},266,{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":299,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":318},"100483771","phase-1-rinatabart-sesutecan-rina-s-pro1184-gen1184-for-advanced-solid-tumors-gct1184-01-pro1184-001-100483771","NCT05579366","Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01\u002F PRO1184-001)","Phase 1\u002F2 Study of Rina-S in Patients With Locally Advanced and\u002For Metastatic Solid Tumors","RAINFOL-01","Inclusion Criteria:\n\nPart A and B:\n\n* Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma or cervical cancer (Part B).\n* Previously received therapies known to confer clinical benefit.\n* Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.\n\nPart C, E, and H:\n\nParticipants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below.\n\n* High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)\n* Participants must have received up to 3 prior lines of therapy. Participants may have had up to to 4 prior lines of therapy are allowed if MIRV is locally approved and was used as the last line of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.\n* Participants must have platinum-resistant ovarian cancer.\n* Participants must have received prior bevacizumab or approved biosimilar.\n* Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration \\[FDA\\]-approved test in a Clinical Laboratory Improvement Amendments \\[CLIA\\]-certified laboratory; or locally approved equivalent) and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment.\n* Measurable disease per the RECIST v1.1 at baseline.\n\nPart D:\n\nCohort D1:\n\n* Participants must have platinum-sensitive ovarian cancer.\n* Participants must have received 1 to 3 prior lines of therapy.\n\nCohort D2:\n\n* Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.\n* Participants with primary platinum-refractory ovarian cancer must have received ≤2 prior lines of therapy. Primary platinum-refractory ovarian cancer is defined as a lack of response or by progression within 91 days after completing front-line platinum containing therapy.\n* Participants must have received 1 to 3 prior lines of therapy for platinum-resistant ovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitive ovarian cancer (PSOC). Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV.\n\n  * Participants with PSOC must have disease progression on or after maintenance treatment, or at least 6 months (\\>183 days) or more from the last dose of platinum-based therapy.\n\nCohort D3:\n\n• Endometrial cancer (any subtype excluding sarcoma).\n\nCohort D4:\n\n• Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).\n\nPart F and G:\n\n* Participants must have histologically or cytologically confirmed EC.\n* Recurrent progressive EC (any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.\n* Participants must have received 1 to 3 prior lines of therapy, and must have progressed radiographically on or after their most recent line of therapy:\n* Participants must have received prior platinum-based chemotherapy and a programmed death-ligand 1 (PD-\\[L\\])1 inhibitor.\n* Participants who progress \\>12 months after completion of prior adjuvant or neoadjuvant platinum-based chemotherapy must receive 1 additional cytotoxic systemic treatment prior to enrollment in this study.\n* Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart I:\n\n* Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer (excluding clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies or low grade\u002Fborderline ovarian tumors).\n* Participants must have platinum sensitive ovarian cancer.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart J:\n\n* Participants must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart K:\n\n* Participants must have histologically or cytologically confirmed metastatic or unresectable ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element).\n* Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nExclusion Criteria:\n\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids within the past 2 years, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.\n\nNote: Other protocol-defined inclusion\u002Fexclusion may apply.",{"count":281,"type":21},884,[51,24],"This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.\n\nParticipants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).",[285,286,287,288,224,289,290,291,292,293,294,295,296,297,298],"High Grade Epithelial Ovarian Cancer","High Grade Serous Ovarian Cancer","Primary Peritoneal Carcinoma","Fallopian Tube Cancer","Non-small Cell Lung Cancer","Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC)","Mesothelioma","Breast Adenocarcinoma","Triple Negative Breast Cancer","Hormone Receptor-positive\u002FHer2 Negative Breast Cancer","Platinum-resistant Ovarian Cancer (PROC)","Platinum Sensitive Ovarian Cancer (PSOC)","Primary Refractory Ovarian Cancer","Uterine Cancer",[82,300,87,301,84,302,85,303,304,305,306,307,308,309,310,311],"folate receptor alpha","solid tumor","primary peritoneal carcinoma","endometrial cancer","non-small cell lung cancer","mesothelioma","breast cancer","triple negative breast cancer","hormone receptor-positive (HR+)\u002Fhuman epidermal growth factor receptor 2 negative (HER2-) breast cancer","topoisomerase I inhibitor","PROC","epidermal growth factor receptor (EGFR)-mutated NSCLC",{"date":119,"type":32},{"date":314,"type":32},"2022-12-07",{"date":316,"type":21},"2027-10",{"name":38,"class":39},66,{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":22,"phases":328,"briefSummary":329,"conditions":330,"keywords":332,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":352},"100461060","phase-2-a-study-to-evaluate-adverse-events-and-change-in-disease-activity-of-subcutaneous-sc-epcoritamab-in-combination-with-oral-and-intravenous-anti-neoplastic-agents-in-adult-participants-with-non-hodgkin-lymphoma-100461060","NCT05283720","A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma","Phase 1b\u002F2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Diagnosis of:\n\n  \\-- Diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma (FL) or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report:\n  * DLBCL, not otherwise specified (NOS).\n  * High-grade B cell lymphoma with MYC and BCL-2 and\u002For BCL-6 translocations per WHO 2016 (\"double-hit\" or \"triple-hit\") Note: High-grade B-cell lymphomas NOS or other double- \u002Ftriple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible.\n  * Follicular lymphoma (FL) Grade 3B. OR\n* FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR\n* Mantle cell lymphoma (MCL) with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR).\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2, except for Arm 6A where ECOG performance status must be 0-1.\n* Must have 1 or more measurable disease sites:\n\n  * A positron emission tomography (PET) \u002Fcomputed tomography (CT) scan demonstrating PET-positive lesion(s) AND\n  * At least 1 measurable nodal lesion (long axis \\> 1.5 cm) or \\>= 1 measurable extra-nodal lesion (long axis \\> 1.0 cm) on CT scan or magnetic resonance imaging (MRI).\n\nExclusion Criteria:\n\n* Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20.\n* Toxicities from prior anticancer therapy that have not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia. Other eligibility criteria (e.g., laboratory, cardiac criteria) must also be met.",{"count":327,"type":21},496,[24],"B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed.\n\nEpcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 496 adult participants with NHL will be enrolled in 100 sites globally.\n\nIn both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28 day, 21 day, or 56 day cycles dependent on the arm in combination with the anti-neoplastic agents described below:\n\n1: Oral lenalidomide in participants (PPTS) with relapsed\u002Frefractory (R\u002FR) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in PPTS with R\u002FR DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in PPTS with newly diagnosed treatment-naïve DLBCL, or completion of treatment in 3B; 4: Oral CC-99282 in PPTS with R\u002FR DLBCL; 5: Oral CC-99282 in PPTS with R\u002FR follicular lymphoma (FL); 6A: Oral ibrutinib in PPTS with R\u002FR mantle cell lymphoma (MCL).\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[331],"Non-Hodgkin Lymphoma",[331,251,253,333,334,252,256,335,336,337,250,338,339,340,341,342,343,344,345],"Ibrutinib","Polatuzumab Vedotin","Doxorubicin Hydrochloride (HCl]","Prednisone (pola-R-CHP)","ABBV-GMAB-3013","Relapsed\u002FRefractory (R\u002FR) Diffuse Large B-Cell Lymphoma (DLBCL), Venetoclax,","Venclexta","ABT-199","GDC-0199","CC-99282","EPCORE","Pirtobrutinib","Mantle Cell Lymhoma",{"date":96,"type":32},{"date":348,"type":32},"2022-06-14",{"date":350,"type":21},"2032-11",{"name":38,"class":39},76,""]