A Multiple Ascending Dose Study of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies
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
1 other identifier
interventional
67
3 countries
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2017
Typical duration for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2017
CompletedStudy Start
First participant enrolled
March 29, 2017
CompletedFirst Posted
Study publicly available on registry
April 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2020
CompletedFebruary 28, 2020
February 1, 2020
2.8 years
March 29, 2017
February 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
To assess serum chemistry, hematology, Coagulation and urinalysis
From time of informed consent and up to 21 days post end of treatment
Secondary Outcomes (11)
MEDI7247 maximum observed concentration for PK
From time of informed consent through 30 days post end of treatment
MEDI7247 area under the concentration-time curve for PK
From time of informed consent through 30 days post end of treatment
MEDI7247 clearance for PK
From time of informed consent through 30 days post end of treatment
MEDI7247 terminal half-life for PK
From time of informed consent through 30 days post end of treatment
Number of subjects who develop anti-drug antibodies (ADAs)
From time of informed consent through 30 days post end of treatment
- +6 more secondary outcomes
Study Arms (3)
acute myeloid leukemia
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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
EXPERIMENTALPatients with R/R DLBCL who have failed prior standard therapy(ies) and for whom there is no standard salvage regimen.
Interventions
The study will enroll patients with R/R AML/MM/DLBCL who will receive MEDI7247 IV
Eligibility Criteria
You may qualify if:
- Confirmed relapsed/refractory diagnosis of select hematologic malignancies for which no standard/salvage therapies are available.
- Age ≥ 18 years at the time of screening.
- Written informed consent and any locally required authorization
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Liver Function Tests: AST and ALT ≤ 3 × ULN, and serum TBL ≤ 1.5 × ULN, unless consistent with Gilbert's syndrome for which TBL ≤ 2.5 × ULN is allowed.
- \. 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.
- \. 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.
You may not qualify if:
- Received cytotoxic chemotherapy within 21 days (or 42 days for nitrosureas or mitomycin C) prior to the first scheduled dose of MEDI7247.
- Received major surgery (as defined by the Investigator), radiotherapy, or immunotherapy (including immune checkpoint inhibitors and adoptive cellular therapy such as autologous or donor NK cell or T lymphocyte infusions (e.g. CAR -T cells)) within 28 days of the first scheduled dose of MEDI7247.
- Received an investigational drug within 14 days of the first scheduled dose of MEDI7247 or not recovered from associated toxicities.
- Patients who have previously received an autologous SCT, are excluded if less than 120 days have elapsed from the time of transplant or the patient has not recovered from transplant-associated toxicities prior to the first scheduled dose of MEDI7247.
- History of liver cirrhosis, liver fibrosis or prior liver irradiation regardless of the time interval (not including total body irradiation administered during allogeneic SCT).
- Failure to recover from all prior treatment-related non-hematological toxicities to ≤ Grade 1 prior to the first scheduled dose of MEDI7247 (except for alopecia and neuropathy).
- Patients at risk of non-disease related major bleeding (eg, recent GI hemorrhage or neurosurgery, within previous 21 days).
- Current severe active systemic disease including active concurrent malignancy
- Central nervous system (CNS) disease that is untreated, symptomatic, or requires therapy to control symptoms.
- Active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infections at the time of screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (14)
Research Site
Los Angeles, California, 90095, United States
Research Site
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
Related Publications (1)
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.
PMID: 38683495DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2017
First Posted
April 10, 2017
Study Start
March 29, 2017
Primary Completion
January 3, 2020
Study Completion
January 3, 2020
Last Updated
February 28, 2020
Record last verified: 2020-02