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Summary

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

Description

Summary

To evaluate MEDI9197 when administered by intratumoral injection to subjects with solid tumors or CTCL, and in combination with durvalumab and/or palliative radiation in subjects with solid tumors.

Official Title

A Phase I, First-Time-in-Human Study of MEDI9197, a TLR 7/8 Agonist, Administered Intratumorally as a Single Agent in Subjects With Solid Tumors or CTCL and in Combination With Durvalumab and/or Palliative Radiation in Subjects With Solid Tumors

Details

This is a multicenter, unblinded study to evaluate the TLR 7/8 agonist MEDI9197 delivered by IT injection to subjects with solid tumors or CTCL, and in combination with durvalumab and/or palliative radiation in subjects with solid tumors. The study uses a 3 + 3 dose escalation design to evaluate a range of doses.

Keywords

Solid Tumors CTCL Cancer MEDI9197 TLR 7/8 Agonist Durvalumab MEDI4736 Imfinzi Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 18–99

  1. Male and female subjects at least 18 years at the time of screening
  2. Adequate organ function within 14 days of enrollment confirmed by laboratory results
  3. Off immunosuppressive medications including, but not limited to, systemic corticosteroids at doses exceeding 10 mg/day prednisone or equivalent

Additional Inclusion Criteria for Part 1:

  1. Metastatic/locally advanced solid tumor malignancy that has progressed on, is refractory to, or for which there is no standard of care therapy
  2. At least one lesion that is easily accessible for injection (subjects enrolled prior to Amendment 3 only)
  3. At least one deep-seated lesion suitable for intervention (subjects enrolled in the deep-seated lesion expansion portion only)
  4. At least 2 lesions (for subjects enrolled to evaluate addition of concurrent palliative radiation to MEDI9197 therapy)

Additional Inclusion Criteria for Subjects in Part 2

  1. Clinical diagnosis of CTCL, including documentation of a skin biopsy with histological findings consistent with CTCL
  2. Stage IB, IIA or IIB disease: T1, T2 or T3 (patches, plaques or tumors) with measurable lesions
  3. Previous treatment with at least one standard therapy used to treat the stage of disease at study entry
  4. At least 2 lesions amenable to response assessment

Additional Inclusion Criteria for Subjects in Part 3A and 3B

  1. Metastatic/locally advanced solid tumor malignancy that has progressed on, is refractory to, or for which there is no standard of care therapy

You CAN'T join if...

Any of the following would exclude the subject from participation in the study:

  1. Subjects who have received prior immunotherapy are NOT permitted to enroll unless all of the following apply:
  2. Prior anti-CTLA 4 inhibitor last dose administered at least 100 days ago. Other prior immunotherapies, the last dose administered at least 28 days prior to planned first dose of MEDI9197
  3. Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy
  4. All AEs while receiving prior immunotherapy must have resolved to ≤ Grade 1 or baseline prior to screening for this study. Must not have experienced a ≥ Grade 3 AE or neurologic, pneumonitis or ocular AE of any grade while receiving prior immunotherapy
  5. Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day
  6. Pregnant or lactating
  7. Active bacterial, fungal, or viral infections
  8. Active autoimmune disease, chronic inflammatory condition, conditions requiring concurrent use of any systemic immunosuppressants or steroids
  9. Immune-deficiency states - myelodysplastic disorders, marrow failures, human immunodeficiency virus (HIV) infection, history of solid organ transplant or bone marrow allograft, or recent pregnancy
  10. Requires continuous anticoagulation or antiplatelet therapy.
  11. History of coagulopathy resulting in uncontrolled bleeding.
  12. Rapidly progressing disease
  13. Untreated or uncontrolled central nervous system (CNS) involvement.
  14. . Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
  15. . Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 Grade 0 or 1, with exception of alopecia, vitiligo and laboratory values listed per inclusion criteria
  16. . Chronic active hepatitis B or C
  17. . Known allergy to sesame oil and/or nuts
  18. . Cardiac exclusions: New York Heart Association Class 3 or 4 congestive heart failure,uncontrolled hypertension, unstable angina pectoris, clinical important cardiac arrhythmia, mean QTC interval corrected for heart rate >500ms
  19. . Major surgery within 4 weeks prior to study entry or still recovering from prior surgery
  20. . Receipt of live, attenuated vaccine within 28 days prior to study entry.
  21. . Receipt of any systemic anticancer therapy not mentioned above within the last 2 weeks or 5 half-lives
  22. . Subjects with CTCL, must not have had prior therapy with Imiquimod, total body electron beam radiation, investigational drugs or treatments within 8 weeks. They must not have had prior therapy with local radiation, UBV therapy, PUVA, any topical chemotherapy, photopheresis, systemic retinoids, corticosteroids, immune response modifiers, IFN inducers, chemotherapeutic agents or biological agents or any topical treatment within 4 weeks. They must not have a known history or positive test for infection with HTLV-1.
  23. . Cognitive disorder such that informed consent cannot be obtained directly from the subject
  24. . Subjects who have previously participated in this study and received MEDI9197.
  25. . Subjects who have received prior TLR agonists, both systemic and topical.
  26. . Patients who have received prior therapeutic radiation within 28 days of dosing. All toxicities from prior radiotherapy must have resolved to ≤ Grade 1 or baseline prior to dosing.

Locations

  • Research Site accepting new patients
    San Francisco, California, 94115, United States
  • Research Site accepting new patients
    Aurora, Colorado, 80045, United States
  • Research Site accepting new patients
    Houston, Texas, 77030, United States
  • Research Site accepting new patients
    Minneapolis, Minnesota, 55455, United States
  • Research Site accepting new patients
    Saint Louis, Missouri, 63110, United States
  • Research Site accepting new patients
    Toronto, Ontario, M5G 1Z6, Canada
  • Research Site withdrawn
    Tampa, Florida, 33612, United States
  • Research Site accepting new patients
    Chapel Hill, North Carolina, 27599-7305, United States
  • Research Site accepting new patients
    Philadelphia, Pennsylvania, 19104, United States
  • Research Site accepting new patients
    New York, New York, 10029, United States
  • Research Site accepting new patients
    Paris, 94805, France

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MedImmune LLC
ID
NCT02556463
Phase
Phase 1
Lead Scientist
Pamela Munster
Study Type
Interventional
Last Updated
October 20, 2017
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