A Multiple Ascending Dose Study of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies

Overview

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.

SparkCures ID 876
Trial Phase Phase 1
Enrollment 228 Patients
Treatments
Trial Sponsors
  • MedImmune
NCT Identifier

NCT03106428

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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.
  6. CrCL ≥ 40 mL/min
  7. 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.
  8. 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.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified Winship Cancer Institute of Emory University<br />

SparkCures Verified Accurate, up-to-date information. Learn more


MedImmune Research Site

Denver, CO

Prisma Health
Greer

Greer, SC

Tennessee Oncology
Centennial Clinic

Nashville, TN

MedImmune Research Site

San Antonio, TX

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

MedImmune Research Site

Chicago, IL

California
Colorado
MedImmune Research Site

Denver, CO

Florida
Georgia
Verified Winship Cancer Institute of Emory University<br />

SparkCures Verified Accurate, up-to-date information. Learn more

Illinois
MedImmune Research Site

Chicago, IL

Massachusetts
Missouri
New York
South Carolina
Prisma Health
Greer

Greer, SC

Tennessee
Tennessee Oncology
Centennial Clinic

Nashville, TN

Texas
MedImmune Research Site

San Antonio, TX

International Locations

This trial has active trial locations in countries outside of the United States.

Our system currently only provides clinical trial matching services for myeloma patients in the United States.

You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please note the information provided through the government website may be inaccurate and/or out-dated.

Resources

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