A Phase 1/2 Study to Evaluate MEDI4736

Not Recruiting

Trial ID: NCT01693562

Purpose

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.

Official Title

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

Stanford Investigator(s)

Kavitha Ramchandran
Kavitha Ramchandran

Clinical Professor, Medicine - Oncology

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Millie Das
Millie Das

Clinical Professor, Medicine - Oncology

Eligibility


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, 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)

Exclusion Criteria:

   - 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
   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 participants)

Intervention(s):

drug: MEDI4736

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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