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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
MedImmune LLC
Study ID
NCT03889275
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • MEDI5395 — BIOLOGICAL
    Participants will receive multiple dose levels of MEDI5395 over several days as stated in arm description.
  • Durvalumab — BIOLOGICAL
    Participants will receive IV infusion of durvalumab as stated in arm description.

Study Details

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

Key Dates

Start date
Oct 24, 2019
Status verified
Feb 2023
Primary completion
Nov 19, 2021
Completion
Dec 12, 2022

Study Design

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

Arms

  • Experimental: Cohort 1A: MEDI5395 Dose Level 1 + Sequential Durvalumab
    Participants will receive IV infusions of MEDI5395 Dose Level 1 on Days 1, 4, 8, 10, 12, and 15 followed by durvalumab every 4 weeks (Q4W) starting from 14 days after the last dose of MEDI5395 for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
  • Experimental: Cohort 2A: MEDI5395 Dose Level 2 + Sequential Durvalumab
    Participants will receive IV infusions of MEDI5395 Dose Level 2 on Days 1, 4, 8, 10, 12, and 15 followed by durvalumab Q4W starting from 14 days after the last dose of MEDI5395 for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
  • Experimental: Cohort 3A: MEDI5395 Dose Level 3 + Sequential Durvalumab
    Participants will receive IV infusions of MEDI5395 Dose Level 3 on Days 1, 4, 8, 10, 12, and 15 followed by durvalumab Q4W starting from 14 days after the last dose of MEDI5395 for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
  • Experimental: Cohort 3A Backfill: MEDI5395 Dose Level 3 + Sequential Durvalumab
    Participants will receive IV infusions of MEDI5395 Dose Level 2 on Day 1 and Dose Level 3 on Days 4, 8, 10, 12, and 15 followed by durvalumab Q4W starting from 14 days after the last dose of MEDI5395 for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
  • Experimental: Cohort 4A: MEDI5395 Dose Level 4 + Sequential Durvalumab
    Participants will receive IV infusions of MEDI5395 Dose Level 2 on Day 1 and Dose Level 4 on Days 4, 8, 10, 12, and 15 followed by durvalumab Q4W starting from 14 days after the last dose of MEDI5395 for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
  • Experimental: Cohort 1B: MEDI5395 Dose Level 1 + Concurrent Durvalumab
    Participants will receive IV infusions of MEDI5395 Dose Level 1 on Days 1, 4, 8, 10, 12, and 15 and durvalumab Q4W, starting from the same day as third dose of MEDI5395, for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
  • Experimental: Cohort 2B: MEDI5395 Dose Level 2 + Concurrent Durvalumab
    Participants will receive IV infusions of MEDI5395 Dose Level 2 on Days 1, 4, 8, 10, 12, and 15 and durvalumab Q4W, starting from the same day as third dose of MEDI5395, for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
  • Experimental: Cohort 3B: MEDI5395 Dose Level 3 + Concurrent Durvalumab
    Participants will receive IV infusions of MEDI5395 Dose Level 3 on Days 1, 4, 8, 10, 12, and 15 and durvalumab Q4W, starting from the same day as third dose of MEDI5395, for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: From first dose of MEDI5395 through 14.4 months (corresponding to maximum observed duration) ]

Locations (8)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85054-
Research SiteLa JollaCalifornia92093-
Research SiteRochesterMinnesota55905-
Research SiteBuffaloNew York14263-
Research SiteNew YorkNew York10065-
Research SiteChapel HillNorth Carolina27599-
Research SitePittsburghPennsylvania15232-
Research SiteProvidenceRhode Island02903-

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