{ "data": { "asOf": "2026-10-30T22:26:36.347Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07384715", "title": "First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)", "scientificTitle": "An Open-Label, Multicenter, First-in-Human Trial of GEN3018 in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome", "status": "recruiting", "studyType": "interventional", "phase": [ "PHASE1" ], "conditions": [ "R/R AML", "R/R HR-MDS", "Acute Myeloid Leukemia", "Higher-Risk Myelodysplastic Syndrome" ], "interventions": [ { "name": "GEN3018", "type": "BIOLOGICAL", "description": "Intravenous (IV) infusion." } ], "sponsor": { "name": "Genmab", "type": "INDUSTRY" }, "locations": [ { "city": "Aarhus", "country": "Denmark", "facility": "Aarhus Universitetshospital - Skejby" }, { "city": "Copenhagen", "country": "Denmark", "facility": "Copenhagen Rigshospitalet" }, { "city": "Bergamo", "country": "Italy", "facility": "ASST Papa Giovanni XXIII" }, { "city": "Milan", "country": "Italy", "facility": "Istituto Clinico Humanitas" }, { "city": "Pisa", "country": "Italy", "facility": "Azienda Ospedaliero Universitaria Pisana" }, { "city": "Barcelona", "country": "Spain", "facility": "Hospital Universitari Vall d'Hebron" }, { "city": "Barcelona", "country": "Spain", "facility": "Hospital Clínic de Barcelona" }, { "city": "Madrid", "country": "Spain", "facility": "Hospital Universitario 12 de Octubre" }, { "city": "Valencia", "country": "Spain", "facility": "Hospital Universitari i Politècnic La Fe" } ], "outcomes": { "other": [], "primary": [ "Part 1: Number of Participants with Dose-limiting Toxicities (DLTs)", "Parts 1 and 2: Number of Participants with Adverse Events (AEs)" ], "secondary": [ "Parts 1 and 2: Maximum Concentration (Cmax) of GEN3018", "Parts 1 and 2: Time to Cmax (tmax) of GEN3018", "Parts 1 and 2: Predose Trough Concentration (Ctrough) of GEN3018", "Parts 1 and 2: Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Sample (AUClast) of GEN3018", "Parts 1 and 2: Elimination Half-life (t1/2) of GEN3018", "Parts 1 and 2: Clearance (CL) of GEN3018", "Parts 1 and 2: Number of Participants with Anti-drug Antibodies (ADAs) Against GEN3018", "Parts 1 and 2: ORR", "Parts 1 and 2: Duration of Response (DOR)", "Parts 1 and 2: Time to Response (TTR)" ] }, "eligibility": { "sex": "ALL", "criteria": "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/R 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/R 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.", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 78 }, "startDate": "2026-02-16", "completionDate": "2030-04-20", "lastUpdated": "2026-10-27T00:00:00.000Z", "firstPosted": "2026-02-03T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07384715" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07384715", "declaredBy": "clinicaltrials_gov" }, { "idType": "euct", "idValue": "2025-523101-15-00", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07384715", "sourceUrl": "https://clinicaltrials.gov/study/NCT07384715", "sourceStatus": "RECRUITING", "retrievedAt": "2026-10-28T04:32:19.317Z", "payloadSha256": "b6e83cea3ab513a5d8c76854b1c36b397648a528cf601dfe3e38557111e5054d", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07384715", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07384715", "verifyAt": "https://clinicaltrials.gov/study/NCT07384715", "retrievedAt": "2026-10-28T04:32:19.317Z", "payloadSha256": "b6e83cea3ab513a5d8c76854b1c36b397648a528cf601dfe3e38557111e5054d", "text": "ClinicalTrials.gov, record NCT07384715 (https://clinicaltrials.gov/study/NCT07384715), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07384715, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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