Skip to main content

Summary

for people ages 18–99 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Advanced Solid Tumors Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 18–99

  • 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)

Locations

  • Research Site
    San Francisco, California, 94118, United States
  • Research Site
    Palo Alto, California, 94304-5826, United States
  • Research Site
    Gilroy, California, 95020, United States
  • Research Site
    Burbank, California, 91505, United States
  • Research Site
    Los Angeles, California, 90025, United States
  • Research Site
    Whittier, California, 90603, United States
  • Research Site
    Los Angeles, California, 90095, United States
  • Research Site
    Orange, California, 92868, United States
  • Research Site
    Las Vegas, Nevada, 89169, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MedImmune LLC
ID
NCT01693562
Phase
Phase 1/2
Lead Scientist
Jennifer Clarke
Study Type
Interventional
Last Updated
October 4, 2017