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A Study of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors

Trial Status: Active

The reason for the study is to find out if MEDI5395 and durvalumab will work and be safe for the treatment of solid tumors.

Inclusion Criteria

  • The subject must consent to take precautionary measures to prevent Newcastle Disease Virus (NDV) transmission to humans and birds
  • Subjects must have histologic documentation of advanced solid tumor and received and have progressed, are refractory, or are intolerant to standard therapy for the specific tumor type. All subjects are required to have had at least one prior line of treatment in the recurrent or metastatic setting
  • Subjects must have at least 1 measurable lesion and an additional non-lymph node non-target lesion that can be biopsied at acceptable risk as judged by the investigator. (Note: if a non-target lesion is not available or cannot be biopsied, a RECIST target, non-lymph node lesion, lesion ≥ 2 cm in longest diameter may be used for non-excisional biopsy
  • All subjects must consent to provide tumor tissue for correlative studies
  • ECOG performance status of 0 to 1
  • Adequate organ function
  • Use of highly effective contraception (females) or male condom plus spermicide (males)

Exclusion Criteria

  • Rapidly progressing disease defined as a subject that cannot tolerate a break of at least 8 weeks from systemic anticancer therapy.
  • Primary central nervous system (CNS) disease is excluded
  • Subjects who have received prior immunotherapy within 28 days prior to the first dose of MEDI5395
  • Unresolved toxicities from prior anticancer therapy that led to permanent discontinuation of prior immunotherapy or that required immunosuppression other than corticosteroids
  • History of severe allergic reactions to any of the study drug components
  • Infectious disease exclusions including tuberculosis, Human immunodeficiency virus (HIV), hepatitis A, B or C, active bacterial, fungal or viral infections plus receipt of live attenuated vaccine prior to first dose of MEDI5395. (NOTE: Subjects with evidence of fully recovered past hepatitis B infection who developed immunity OR hepatitis B/C with undetectable virus load and are on medications may be permitted).
  • Positive SARS-CoV-2 diagnostic test at screening
  • Any conditions requiring use of any systemic immunosuppressant including systemic corticosteroids, methotrexate, azathioprine, tumor necrosis factor (TNF) inhibitor, and/or interleukin 6 (IL-6) blockers
  • Active autoimmune disease or chronic inflammatory condition (Exceptions include vitiligo, alopecia, hypothyroidism on stable treatment, diverticulosis, controlled celiac disease and chronic skin conditions not requiring systemic therapy)
  • Active acquired immune-deficiency states
  • Subjects who are regularly exposed to poultry or birds
  • Current active hepatitis or biliary disease (except for Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease)
  • Clinically significant pulmonary disease and cardiac disease
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.

Arizona

Phoenix
Mayo Clinic Hospital in Arizona
Status: ACTIVE
Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE

California

San Diego
University of California San Diego
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Dmitriy Zamarin
Phone: 646-888-4882

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

This is an Phase 1, first-in-human, open-label, dose-escalation, and dose-expansion study to

assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary

efficacy of MEDI5395 in combination with durvalumab in subjects with selected advanced solid

tumors.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
MedImmune Inc

  • Primary ID D6450C00001
  • Secondary IDs NCI-2019-07042
  • Clinicaltrials.gov ID NCT03889275