Trial Type
First-Line-Therapy (Metastatic Disease/Hematology)
Description for experts
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of JNJ-75276617 in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of JNJ-75276617 in combination with AML directed therapies at the RP2D(s) (dose expansion).
Description for laymen
The purpose of this study is to determine the recommended Phase 2 dose(s) of JNJ-75276617 in combination with AML-targeted therapies (dose selection) and also to evaluate the safety and tolerability of JNJ-75276617 in combination with AML-targeted therapies in RP2D(s) (dose expansion).
JSON Data
{
"short_title": "Janssen 75276617ALE1002",
"data_mode": "900",
"data_mode_number": "000002246",
"official_title": "A Phase 1b Study of JNJ-75276617 in Combination With AML Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "first",
"ctgov_number": "NCT05453903",
"eudract_number": "2021-003999-14",
"general_contact_email": "ectu@ukdd.de",
"general_contact_phone": "+49 351-4587566",
"hauptpruefer_dd_name": "Dr. med. Christoph R\u00f6llig",
"description_laie_de": "Ziel dieser Studie ist es, die empfohlene(n) Phase-2-Dosis(en) von JNJ-75276617 in Kombination mit AML-gerichteten Therapien zu bestimmen (Dosisauswahl) und dar\u00fcber hinaus die Sicherheit und Vertr\u00e4glichkeit von JNJ-75276617 in Kombination mit AML-gerichteten Therapien bei der/den RP2D(s) zu bewerten (Dosisausweitung).",
"description_laie_en": "The purpose of this study is to determine the recommended Phase 2 dose(s) of JNJ-75276617 in combination with AML-targeted therapies (dose selection) and also to evaluate the safety and tolerability of JNJ-75276617 in combination with AML-targeted therapies in RP2D(s) (dose expansion).",
"description_expert_de": "Ziel dieser Studie ist es, die empfohlene(n) Phase-2-Dosis(en) von JNJ-75276617 in Kombination mit AML-gerichteten Therapien zu bestimmen (Dosisauswahl) und dar\u00fcber hinaus die Sicherheit und Vertr\u00e4glichkeit von JNJ-75276617 in Kombination mit AML-gerichteten Therapien bei der/den RP2D(s) zu bewerten (Dosisausweitung).",
"description_expert_en": "The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of JNJ-75276617 in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of JNJ-75276617 in combination with AML directed therapies at the RP2D(s) (dose expansion).",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "I",
"main_cat_id": 4,
"sub_cat_id": 30
}
