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

Part of paid clinical trials in La Jolla, California.

Sponsor
MedImmune LLC
Study ID
NCT03946800
Phase
PHASE1
Status
Completed

Conditions

  • Cancer
  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 101 Years
Healthy Volunteers
Not accepted

Interventions

  • MEDI1191 — BIOLOGICAL
    Subjects will receive MEDI1191 (at least twice)
  • Durvalumab — BIOLOGICAL
    Subject will receive durvalumab every 4 weeks

Study Details

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

Key Dates

Start date
May 8, 2019
Status verified
Sep 2024
Primary completion
Aug 24, 2023
Completion
Aug 24, 2023

Study Design

Enrollment
61 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MEDI1191 escalation in combination with durvalumab
    MEDI1191 escalation in sequential and concurrent combination with durvalumab
  • Experimental: MEDI1191 expansion in combination with durvalumab
    MEDI1191 expansion in concurrent combination with durvalumab

Primary Outcome Measure

Number of subjects with adverse events (AEs) serious adverse events (SAEs) and dose limiting toxicities (DLTs). [ Time Frame: From time of informed consent until 90 days after the last dose of investigational product (MEDI1191 or durvalumab). ]

Locations (8)

FacilityCityStateZIPSite coordinators
Research SiteLa JollaCalifornia92093-
Research SiteLos AngelesCalifornia90025-
Research SiteLos AngelesCalifornia90089-
Research SiteNew YorkNew York10029-
Research SiteNew YorkNew York10065-
Research SiteThe BronxNew York10461-
Research SiteProvidenceRhode Island02903-
Research SiteHoustonTexas77030-

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