A Phase 1/2 Study to Evaluate MEDI4736



Status:Active, not recruiting
Conditions:Breast Cancer, Lung Cancer, Colorectal Cancer, Skin Cancer, Liver Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:3/22/2019
Start Date:August 29, 2012
End Date:November 29, 2019

Use our guide to learn which trials are right for you!

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors

This is a multicenter, open-label, first-time-in-human study with a standard 3+3
dose-escalation phase in subjects with advanced solid tumors followed by an expansion phase
in patients with advanced solid tumors. An exploration cohort has been added to determine the
safety using Q4W dosing.

A dose-escalation and dose-expansion study of MEDI4736 (a monoclonal antibody that targets
programmed cell death-1 ligand 1 (PD-L1)) will evaluate the safety, tolerability, PK, IM, and
antitumor activity of MEDI4736 in adult patients with solid tumors. A dose exploration cohort
will look at the safety profile of Q4W dosing of MEDI4736.

Inclusion Criteria:

- Age 18 or older.

- In the dose-escalation phase: histologically- or cytologically- confirmed advanced
solid tumor that is refractory to standard therapy and for which no standard therapy
exists.

- In the dose-expansion phase: histologically- or cytologically- confirmed advanced
solid tumor where if an approved first-line therapy is available, subjects must have
failed, be intolerant to, be ineligible for, or have refused

- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.

- Adequate organ and marrow function.

- Subjects must have at least 1 measurable lesion.

- Available archived tumor tissue sample.

- Willingness to provide consent for biopsy sample (dose-expansion only)

Exclusion Criteria:

- Any prior Grade ≥ 3 irAE while receiving immunotherapy

- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody

- Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer
treatment.

- Prior treatment with immunotherapy agents including, but not limited to, tumor
necrosis factor receptor superfamily agonists or checkpoint inhibitors or natural
killer (NK) cell inhibitors.

- Active or prior documented autoimmune disease within the past 2 years

- History of primary immunodeficiency

- History of organ transplant that requires use of immunosuppressives

- Symptomatic or untreated central nervous system (CNS) metastases requiring concurrent
treatment

- Other invasive malignancy within 2 years

- Women who are pregnant or lactating

- Uncontrolled intercurrent illness

- Known history of tuberculosis

- Known to be human immunodeficiency virus (HIV) positive

- Known to be Hepatitis B or C positive (except HCC patients)
We found this trial at
45
sites
?
mi
from
Burbank, CA
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Athens, GA
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Billings, MT
Click here to add this to my saved trials
?
mi
from
Blacksburg, VA
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
?
mi
from
Gent,
Click here to add this to my saved trials
?
mi
from
Gilroy, CA
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntersville, North Carolina 28078
?
mi
from
Huntersville, NC
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
?
mi
from
Paterson, NJ
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Saint Louis Park, MN
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Whittier, CA
Click here to add this to my saved trials