Breast Cancer Clinical Trial
A Phase 1/2 Study to Evaluate MEDI4736
Summary
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.
Full Description
A dose-escalation and dose-expansion study of MEDI4736 (a monoclonal antibody that targets programmed cell death ligand-1 (PD-L1)) will evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity (IM), and antitumor activity of MEDI4736 in adult participants with solid tumors. A dose exploration cohort will look at the safety profile of Q4W dosing of MEDI4736.
Eligibility Criteria
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)
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There are 79 Locations for this study
Scottsdale Arizona, 85258, United States
Burbank California, 91505, United States
Gilroy California, 95020, United States
Los Angeles California, 90025, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Palo Alto California, 94304, United States
San Francisco California, 94115, United States
Whittier California, 90603, United States
New Haven Connecticut, 06520, United States
Washington District of Columbia, 20007, United States
Jacksonville Florida, 32224, United States
Miami Beach Florida, 33140, United States
Tampa Florida, 33612, United States
Athens Georgia, 30607, United States
Augusta Georgia, 30912, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Minneapolis Minnesota, 55407, United States
Saint Louis Park Minnesota, 55416, United States
Billings Montana, 59101, United States
Las Vegas Nevada, 89169, United States
Hackensack New Jersey, 07601, United States
Paterson New Jersey, 07503, United States
Bronx New York, 10461, United States
New York New York, 10065, United States
Chapel Hill North Carolina, 27599, United States
Huntersville North Carolina, 28078, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97213, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15212, United States
Greenville South Carolina, 29605, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75201, United States
Houston Texas, 77030, United States
Houston Texas, 77090, United States
San Antonio Texas, 78229, United States
Salt Lake City Utah, 84403, United States
Blacksburg Virginia, 24060, United States
Fairfax Virginia, 22031, United States
Seattle Washington, 98104, United States
Gent , 9000, Belgium
Leuven , 3000, Belgium
Liege , B-400, Belgium
Namur , 5000, Belgium
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2X 3, Canada
Paris Cedex 10 , 75475, France
Villejuif Cedex , 94800, France
Berlin , 12200, Germany
Gauting , 82131, Germany
Heidelberg , 69120, Germany
Jena , 07747, Germany
Minden , 32429, Germany
Lecce , 73100, Italy
Milano , 20132, Italy
Milan , 20141, Italy
Napoli , 80131, Italy
Siena , 53100, Italy
Gwangju , 61469, Korea, Republic of
Seo-Gu , 49241, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Tainan , 70403, Taiwan
Taipei , 10002, Taiwan
London , EC1A , United Kingdom
London , SW2 6, United Kingdom
London , W1G 6, United Kingdom
Oxford , OX3 7, United Kingdom
Sutton , SM2 5, United Kingdom
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