©2024 Stanford Medicine
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
Clinical Professor, Medicine - Oncology
Joel Neal, MD, PhD
Associate Professor of Medicine (Oncology)
Millie Das
Clinical Professor, Medicine - Oncology
Heather Wakelee
Winston Chen and Phyllis Huang Professor
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