MK-1026

A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic Malignancies This is a multicenter, non-randomized open-label, Phase 2 dose escalation and confirmation followed by a multi-cohort single-group study. This study is designed to first establish the RP2D and then as a proof-of-concept to assess the efficacy and safety of MK-1026 monotherapy across cohorts of participants with various hematological malignancies who have relapsed or are refractory to prior therapies. BTK inhibitors are approved for the treatment of several lymphoproliferative malignancies; however, resistance is known to develop. These hematologic malignancies were selected because each represents a significant unmet medical need and prior BTK inhibitors have shown efficacy in these malignancies.

{ "short_title": "MK-1026", "data_mode": "910", "data_mode_number": "000000017", "official_title": null, "accrual_state": "running", "therapeutic_value": "not_applicable", "therapieansatz_value": "not_applicable", "therapieintervention_value": "not_applicable", "therapielinie_value": "rezidiv_haema", "ctgov_number": null, "eudract_number": "2020-002324-36", "general_contact_email": "sal-aml-register@ukdd.de", "general_contact_phone": "+49 351-45818380", "hauptpruefer_dd_name": null, "description_laie_de": "Multinationalen, multizentrischen, randomisierten, unverblindeten, Phase-II-Studie soll die Wirksamkeit und Sicherheit von MK-1026 bei Patienten mit h\u00e4matologischen b\u00f6sartigen Erkrankungen bewertet werden", "description_laie_en": "A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic Malignancies This is a multicenter, non-randomized open-label, Phase 2 dose escalation and confirmation followed by a multi-cohort single-group study. This study is designed to first establish the RP2D and then as a proof-of-concept to assess the efficacy and safety of MK-1026 \r\nmonotherapy across cohorts of participants with various hematological malignancies who \r\nhave relapsed or are refractory to prior therapies. BTK inhibitors are approved for the \r\ntreatment of several lymphoproliferative malignancies; however, resistance is known to \r\ndevelop. These hematologic malignancies were selected because each represents a significant \r\nunmet medical need and prior BTK inhibitors have shown efficacy in these malignancies.", "description_expert_de": "Multinationalen, multizentrischen, randomisierten, unverblindeten, Phase-II-Studie soll die Wirksamkeit und Sicherheit von MK-1026 bei Patienten mit h\u00e4matologischen b\u00f6sartigen Erkrankungen bewertet werden", "description_expert_en": "A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic Malignancies This is a multicenter, non-randomized open-label, Phase 2 dose escalation and confirmation followed by a multi-cohort single-group study. This study is designed to first establish the RP2D and then as a proof-of-concept to assess the efficacy and safety of MK-1026 \r\nmonotherapy across cohorts of participants with various hematological malignancies who \r\nhave relapsed or are refractory to prior therapies. BTK inhibitors are approved for the \r\ntreatment of several lymphoproliferative malignancies; however, resistance is known to \r\ndevelop. These hematologic malignancies were selected because each represents a significant \r\nunmet medical need and prior BTK inhibitors have shown efficacy in these malignancies.", "rechtsgrundlage_value": null, "phase_amg_value": null, "main_cat_id": 4, "sub_cat_id": 29 }