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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 patients 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acute myeloid leukemia | Experimental | Patients with R/R AML by World Health Organization (WHO) classification (Arber et al, 2016) who have failed prior standard therapy and for whom no standard therapies are available |
|
| Multiple Myeloma | Experimental | Patients with R/R MM who have failed prior standard therapy(ies) which should include immunomodulatory agents and proteasome inhibitors and for whom there is no standard salvage regimen. |
|
| Diffuse Large B-cell Lymphoma | Experimental | Patients with R/R DLBCL who have failed prior standard therapy(ies) and for whom there is no standard salvage regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI7247 | Drug | The study will enroll patients with R/R AML/MM/DLBCL who will receive MEDI7247 IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events (AEs) | To assess by the occurrence of adverse events (AEs) | From time of informed consent through 90 days post end of treatment |
| Occurrence of serious adverse events (SAEs) | To assess by the occurrence of serious adverse events (SAEs) | From time of informed consent through 90 days post end of treatment |
| Occurrence of dose-limiting toxicities (DLTs) | To assess by the occurrence of non-Hematologic and hematologic toxicities, AEs, and abnormal laboratory results. | During the evaluation period of 21 or 42 days post-first dose |
| Number of patients with changes in laboratory parameters from baseline | To assess serum chemistry, hematology, Coagulation and urinalysis | From time of informed consent and up to 21 days post end of treatment |
| Number of patients with changes in vital signs from baseline | To assess body temperature, blood pressure, and heart rate | From time of informed consent and up to 21 days post end of treatment |
| Number of patients with changes in electrocardiogram (ECG) results from baseline | To assess using twelve-lead ECG recordings | From time of informed consent and up to 21 days post end of treatment |
| Percentage of patients with changes in laboratory parameters from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| MEDI7247 maximum observed concentration for PK | To assess the Pharmacokinetics of MEDI7247 | From time of informed consent through 30 days post end of treatment |
| MEDI7247 area under the concentration-time curve for PK |
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Inclusion Criteria:
5. CrCL ≥ 40 mL/min 6. Female patients of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from 7 days post-screening, and must agree to continue using such precautions for 90 days after the last dose of investigational product.
7. Nonsterilized male patients who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from 7 days post-screening and for 90 days after receipt of the last dose of investigational product.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Angeles | California | 90095 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38683495 | Derived | Maris M, Salles G, Kim WS, Kim TM, Lyons RM, Arellano M, Karmali R, Schiller G, Cull E, Abboud CN, Batlevi C, Kagiampakis I, Rebelatto MC, Lee Y, Kirby LC, Wang F, Bothos J, Townsley DM, Fathi AT, Ribrag V. ASCT2-Targeting Antibody-Drug Conjugate MEDI7247 in Adult Patients with Relapsed/Refractory Hematological Malignancies: A First-in-Human, Phase 1 Study. Target Oncol. 2024 May;19(3):321-332. doi: 10.1007/s11523-024-01054-z. Epub 2024 Apr 29. |
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To assess serum chemistry, hematology, Coagulation and urinalysis
| From time of informed consent and up to 21 days post end of treatment |
To assess the Pharmacokinetics of MEDI7247
| From time of informed consent through 30 days post end of treatment |
| MEDI7247 clearance for PK | To assess the Pharmacokinetics of MEDI7247 | From time of informed consent through 30 days post end of treatment |
| MEDI7247 terminal half-life for PK | To assess the Pharmacokinetics of MEDI7247 | From time of informed consent through 30 days post end of treatment |
| Number of subjects who develop anti-drug antibodies (ADAs) | To assess the immunogenicity of MEDI7247 | From time of informed consent through 30 days post end of treatment |
| Best overall response (BOR) | To assess the anti-tumor activity of MEDI7247 | From time of informed consent and up to 3 years after final patient is enrolled |
| Objective response rate (ORR) | To assess the anti-tumor activity of MEDI7247 | From time of informed consent and up to 3 years after final patient is enrolled |
| Time to response (TTR) | To assess the anti-tumor activity of MEDI7247 | From time of informed consent and up to 3 years after final patient is enrolled |
| Duration of response (DoR) | To assess the anti-tumor activity of MEDI7247 | From time of informed consent and up to 3 years after final patient is enrolled |
| Progression-free survival (PFS) | To assess the anti-tumor activity of MEDI7247 | From time of informed consent and up to 3 years after final patient is enrolled |
| Overall survival (OS) | To assess the anti-tumor activity of MEDI7247 | From time of informed consent and up to 3 years after final patient is enrolled |
| Denver |
| Colorado |
| 80218 |
| United States |
| Research Site | Atlanta | Georgia | 30322 | United States |
| Research Site | Chicago | Illinois | 60611 | United States |
| Research Site | Boston | Massachusetts | 02114 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | New York | New York | 10065 | United States |
| Research Site | Greer | South Carolina | 29650 | United States |
| Research Site | Nashville | Tennessee | 37203 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Pierre-Bénite | 69495 | France |
| Research Site | Villejuif | 94805 | France |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 06351 | South Korea |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009101 | Multiple Myeloma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D008206 | Lymphatic Diseases |
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