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 Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors
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.
Advanced Solid TumorsAntibodies, Monoclonal
You can join if…
Open to people ages 18 years to 99 years
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)
You CAN'T join if...
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)