Study identifier:D8540C00001
ClinicalTrials.gov identifier:NCT03106428
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of MEDI7247 in Patients with Selected Relapsed/Refractory Hematological Malignancies
Acute Myeloid Leukemia
Phase 1
No
MEDI7247
All
67
Interventional
18 Years - 100 Years
Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Dec 2020 by MedImmune, LLC
MedImmune, LLC
-
To assess safety and tolerability, describe the dose-limiting toxicities, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of MEDI7247 in participants with selected hematological malignancies who have relapsed after, or are refractory to prior standard therapy, and for whom there is no standard salvage regimen available.
Location
Location
Nashville, TN, United States, 37203
Location
San Antonio, TX, United States, 78229
Location
Denver, CO, United States, 80218
Location
St. Louis, MO, United States, 63110
Location
Los Angeles, CA, United States, 90095
Location
Boston, MA, United States, 02114
Location
Seoul, Republic of Korea, 06351
Location
Greer, SC, United States, 29650
Arms | Assigned Interventions |
---|---|
Experimental: AML: MEDI7247 Dose 2 Participants with acute myeloid leukemia (AML) will receive intravenous (IV) MEDI7247 Dose 2 on Day 1 of each 21-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: AML: MEDI7247 Dose 3 Participants with AML will receive IV MEDI7247 Dose 3 on Day 1 of each 21-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: AML: MEDI7247 Fractionated Dose 3 Participants with AML will receive IV MEDI7247 Dose 3 either on Days 1, 2, and 3 of each 21-day cycle or on Days 1, 8, 15 of each 28-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: AML: MEDI7247 Dose 4 Participants with AML will receive IV MEDI7247 Dose 4 on Day 1 of each 21-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: AML: MEDI7247 Dose 5 Participants with AML will receive IV MEDI7247 Dose 5 on Day 1 of each 21-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: AML: MEDI7247 Dose 6 Participants with AML will receive IV MEDI7247 Dose 6 on Day 1 of each 21-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: AML: MEDI7247 Dose 7 Participants with AML will receive IV MEDI7247 Dose 7 on Day 1 of each 21-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: MM: MEDI7247 Fractionated Dose 1 Participants with multiple myeloma (MM) will receive IV MEDI7247 Dose 1 either on Days 1, 2, and 3 of each 21-day cycle or on Days 1, 8, 15 of each 28-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: MM: MEDI7247 Dose 2 Participants with MM will receive IV MEDI7247 Dose 2 on Day 1 of each 21-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: MM: MEDI7247 Dose 4 Participants with MM will receive IV MEDI7247 Dose 4 on Day 1 of each 21-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: MM: MEDI7247 Dose 5 Participants with MM will receive IV MEDI7247 Dose 5 on Day 1 of each 21-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: MM: MEDI7247 Dose 6 Participants with MM will receive IV MEDI7247 Dose 6 on Day 1 of each 21-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: DLBCL: MEDI7247 Dose 2 Participants with diffuse large B-cell lymphoma (DLBCL) will receive IV MEDI7247 Dose 2 on Day 1 of each 21-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: DLBCL: MEDI7247 Dose 3 Participants with DLBCL will receive IV MEDI7247 Dose 3 on Day 1 of each 21-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: DLBCL: MEDI7247 Fractionated Dose 3 Participants with DLBCL will receive IV MEDI7247 Dose 3 either on Days 1, 2, and 3 of each 21-day cycle or on Days 1, 8, 15 of each 28-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: DLBCL: MEDI7247 Dose 4 Participants with DLBCL will receive IV MEDI7247 Dose 4 on Day 1 of each 21-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: DLBCL: MEDI7247 Dose 5 Participants with DLBCL will receive IV MEDI7247 Dose 5 on Day 1 of each 21-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
Experimental: DLBCL: MEDI7247 Dose 6 Participants with DLBCL will receive IV MEDI7247 Dose 6 on Day 1 of each 21-day cycle (for a maximum of 2 years) until unacceptable toxicity, documentation of disease progression, or development of other reason for treatment discontinuation. | Drug: MEDI7247 Participants with AML or MM or DLBCL will receive IV MEDI7247 doses. |
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