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

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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
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