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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03106428
Other study ID # D8540C00001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 29, 2017
Est. completion date January 3, 2020

Study information

Verified date February 2020
Source MedImmune LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date January 3, 2020
Est. primary completion date January 3, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

1. Confirmed relapsed/refractory diagnosis of select hematologic malignancies for which no standard/salvage therapies are available.

2. Age = 18 years at the time of screening.

3. Written informed consent and any locally required authorization

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

5. 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.

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:

1. Received cytotoxic chemotherapy within 21 days (or 42 days for nitrosureas or mitomycin C) prior to the first scheduled dose of MEDI7247.

2. 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.

3. Received an investigational drug within 14 days of the first scheduled dose of MEDI7247 or not recovered from associated toxicities.

4. 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.

5. History of liver cirrhosis, liver fibrosis or prior liver irradiation regardless of the time interval (not including total body irradiation administered during allogeneic SCT).

6. 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).

7. Patients at risk of non-disease related major bleeding (eg, recent GI hemorrhage or neurosurgery, within previous 21 days).

8. Current severe active systemic disease including active concurrent malignancy

9. Central nervous system (CNS) disease that is untreated, symptomatic, or requires therapy to control symptoms.

10. Active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infections at the time of screening.

Study Design


Intervention

Drug:
MEDI7247
The study will enroll patients with R/R AML/MM/DLBCL who will receive MEDI7247 IV

Locations

Country Name City State
France Research Site Pierre Benite
France Research Site Villejuif
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
United States Research Site Atlanta Georgia
United States Research Site Boston Massachusetts
United States Research Site Chicago Illinois
United States Research Site Denver Colorado
United States Research Site Greer South Carolina
United States Research Site Los Angeles California
United States Research Site Nashville Tennessee
United States Research Site New York New York
United States Research Site Saint Louis Missouri
United States Research Site San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  France,  Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 MEDI7247 maximum observed concentration for PK To assess the Pharmacokinetics of MEDI7247 From time of informed consent through 30 days post end of treatment
Secondary MEDI7247 area under the concentration-time curve for PK To assess the Pharmacokinetics of MEDI7247 From time of informed consent through 30 days post end of treatment
Secondary MEDI7247 clearance for PK To assess the Pharmacokinetics of MEDI7247 From time of informed consent through 30 days post end of treatment
Secondary MEDI7247 terminal half-life for PK To assess the Pharmacokinetics of MEDI7247 From time of informed consent through 30 days post end of treatment
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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