A Study of MEDI1191 in Sequential and Concurrent Combination With Durvalumab in Subjects With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Jan 15, 2027
  • participants needed
    87
  • sponsor
    MedImmune LLC
Updated on 5 May 2022
corticosteroids
prednisone
metastasis
solid tumour
solid tumor
solid neoplasm
advanced malignant solid tumor

Summary

To evaluate MEDI1191 administered intratumorally in sequential and concurrent combination with intravenous durvalumab in patients with solid tumors.

Description

This is a multicenter, open-label study to evaluate MEDI1191 delivered by intratumoral injection in sequential and concurrent combination with intravenous durvalumab to subjects with solid tumors. The study has a dose escalation design using mTPI-2 to evaluate a range of doses.

Details
Condition Solid Tumors, Cancer
Treatment durvalumab, MEDI1191
Clinical Study IdentifierNCT03946800
SponsorMedImmune LLC
Last Modified on5 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

ECOG 0 to 1
Adequate organ function within 2 weeks of starting study treatment
Prior to the first dose of MEDI1191, subjects with central nervous system (CNS) metastases must have been treated and must be asymptomatic
Cessation of systemic corticosteroids at doses exceeding 12 mg/day prednisone or equivalent, methotrexate, azathioprine, ustekinumab (Stelara®), and tumor necrosis factor (TNF)-α/IL-6 blockers for at least 7 days prior to the first dose of MEDI1191
Subjects must have at least one lesion suitable for intratumoral dosing for superficial lesions but at least two lesion suitable for intratumoral dosing for deep-seated lesions
Subjects must have at least one non-injected lesion that can be measured by RECIST v1.1
Histologic or cytologic confirmation of advanced solid tumor
Received and have progressed on or refractory to at least 1 line of standard systemic therapy in the recurrent/metastatic setting
Highly effective method of contraception from screening, and must agree to continue using such precautions for 3 months after the final dose of investigational product
Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from Day 1 through 6 months after receipt of the final dose of investigational product

Exclusion Criteria

Subjects who have received prior IL-12 either alone or as part of a treatment regimen
Subjects who were administered any live attenuated vaccines within 30 days prior to first MEDI1191 injection
Known allergy or hypersensitivity to any component of MEDI1191 or durvalumab formulations
Active or prior documented autoimmune disorders within the past 5 years prior to the first scheduled dose of study treatment except alopecia, hypothyroidism (stable of hormone replacement), chronic skin condition (does not require systemic therapy), and celiac disease (controlled by diet alone)
Immune-deficiency states - myelodysplastic disorders, marrow failure states, human immunodeficiency virus infection, history of solid organ transplant, bone marrow allograft, or active tuberculosis
History of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders
Require continuous anticoagulation or antiplatelet therapy (except for ≤ 100 mg acetylsalicylic acid [ASA]) which cannot be interrupted for more than 7 days for IT delivery of MEDI1191
Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer
Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 7 days prior to the first dose of study treatment. For subjects who have received prior immunotherapy, the following additional exclusion criteria apply
Received only one dose of prior immunotherapy agent alone or as part of a combination regimen
Experienced a toxicity that led to permanent discontinuation of prior immunotherapy
All AEs while receiving prior immunotherapy did not resolve to ≤ Grade 1 or baseline prior to screening for this study
Experienced a ≥ Grade 3 AE (including pneumonitis) or neurologic, ocular, or cardiac AE of any grade while receiving prior immunotherapy
Required the use of additional immunosuppression other than corticosteroids for the management of an AE, or experienced recurrence of an AE if re-challenged, or is currently requiring a maintenance dose of > 12 mg prednisone or equivalent per day
Any toxicity from prior therapy that has not completely resolved to ≤ Grade 1 or
baseline at the time of consent
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI1191, except intranasal, topical, inhaled corticosteroids, local steroid injections, systemic corticosteroids at physiologic doses not to exceed 12 mg/day of prednisone or equivalent, or steroids as premedication for hypersensitivity reactions
Cardiac exclusions: New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled hypertension, acute coronary syndrome within 6 months
Any condition that would interfere with evaluation of the investigational product or interpretation of subject safety or study results
Uncontrolled intercurrent illness
Untreated, active hepatitis B or C
Major surgery within 4 weeks prior to first dose of MEDI1191 or still recovering from prior surgery
Subjects with untreated active major depression with suicidal ideation and/or plan
Female subjects who are pregnant, lactating, or intend to become pregnant during their participation in this study
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