MEDI9447 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors

Status: Active

Description

The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI9447 Alone and in Combination with MEDI4736 in Adult Subjects with Select Advanced Solid Tumors

Eligibility Criteria

Inclusion Criteria

  • Adult subjects; age ≥ 18
  • Written and signed informed consent must be obtained
  • Have histologic or cytologic documentation of solid tumor including EGFR mutated (EGFRm) NSCLC
  • Subjects must have at least 1 lesion that is measureable using RECIST guidelines
  • Subjects must consent to provide archived tumor specimens or tumor biopsies for correlative biomarker studies.
  • Eastern Cooperative Oncology Group performance score of 0 or 1
  • Adequate organ function

Exclusion Criteria

  • Prior treatment with tumor necrosis factor receptor superfamily agonists including OX40, CD27, CD137 (4-1BB), CD357 (GITR). One cohort also excludes anti CTLA-4, anti PDL-1 and anti PDL-1.
  • Subjects who have received prior therapy with regimens containing CTLA-4, PD-L1, or PD-1 antagonists may be permitted to enroll under certain conditions
  • Cardiac or peripheral vascular disease meeting any of the following criteria:
  • Past history of myocardial infarction in the prior 12 months
  • Past history of stroke or transient ischemic attack requiring medical therapy
  • Congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification
  • Grade 3 or greater edema (eg, peripheral, pulmonary)
  • History of Grade 3 or greater thromboembolic events in the prior 12 months
  • Subjects with active tuberculosis are ineligible. In settings where there is clinical or radiographic evidence of tuberculosis, active disease must be ruled out
  • Active or prior documented autoimmune or inflammatory disorders
  • Untreated central nervous system (CNS) metastatic disease
  • Known positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C
  • Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active peptic ulcer disease or gastritis, uncontrolled hypertension, uncontrolled diabetes, or psychiatric illness/social situations that would limit compliance with study requirement

Locations & Contacts

California

San Diego
University of California San Diego
Status: Active
Contact: Gregory Marshall Heestand
Phone: 858-822-5354
Email: cancercto@ucsd.edu

Connecticut

New Haven
Yale University
Status: Active
Contact: Patricia Mucci LoRusso
Phone: 203-785-5702
Email: patricia.lorusso@yale.edu

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: In review
Name Not Available

North Carolina

Durham
Duke University Medical Center
Status: Active
Contact: John Howard Strickler
Phone: 888-275-3853
Email: john.strickler@duke.edu

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
MedImmune Inc

Trial IDs

Primary ID D6070C00001
Secondary IDs NCI-2015-01857
Clinicaltrials.gov ID NCT02503774