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A Phase 1/2 Study to Evaluate MEDI4736
Trial ID: NCT01693562
This is a multicenter, open-label, first-time-in-human study with a standard 3+3 dose-escalation phase in participants with advanced solid tumors followed by an expansion phase in participants with advanced solid tumors. An exploration cohort has been added to determine the safety using every 4 weeks (Q4W) dosing.
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors
- 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
- In the dose-expansion phase: histologically- or cytologically- confirmed advanced
solid tumor where if an approved first-line therapy is available, participants 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.
- Participants must have at least 1 measurable lesion.
- Available archived tumor tissue sample.
- Willingness to provide consent for biopsy sample (dose-expansion only)
- Any prior Grade ≥ 3 immune-mediated adverse event (imAE) 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
- 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
- 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 participants)
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