Overview

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

Status:
Completed
Trial end date:
2020-01-03
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
MedImmune LLC
Criteria
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.