A Study of MEDI9253 in Combination With Durvalumab in Select Solid Tumors

Part of paid clinical trials in St Louis, Missouri.

Sponsor
AstraZeneca
Study ID
NCT04613492
Phase
PHASE1
Status
Terminated

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • MEDI9253 — BIOLOGICAL
    Participants will receive either single or multiple dose of MEDI9253; sequentially or concurrent with Durvalumab
  • Durvalumab — BIOLOGICAL
    Participants will receive durvalumab treatment sequentially or concurrently with MEDI9253

Study Details

Study D7880C00001 is a first-in-human (FIH), Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of MEDI9253 in combination with durvalumab in adult participants with select advanced/metastatic solid tumors.

Key Dates

Start date
Dec 2, 2020
Status verified
Jun 2025
Primary completion
May 31, 2024
Completion
May 31, 2024

Study Design

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

Arms

  • Experimental: MEDI9253 Single Dose Level 1 + Durvalumab 1500 mg Q4W
    Participants will receive intravenous (IV) infusion of a single dose of MEDI9253 dose level 1 on Day 1. After 14 days (+7 days) of MEDI9253 dose, participants will receive IV durvalumab at 1500 mg once every 4 weeks (Q4W) until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity, for up to 2 years.
  • Experimental: MEDI9253 Single Dose Level 2 + Durvalumab 1500 mg Q4W
    Participants will receive IV infusion of a single dose of MEDI9253 dose level 2 on Day 1. After 14 days (+7 days) of MEDI9253 dose, participants will receive IV durvalumab at 1500 mg Q4W until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity, for up to 2 years.
  • Experimental: MEDI9253 Multiple Dose Level 2 + Durvalumab 1500 mg Q4W
    Participants will receive IV infusion of 3 weekly doses (±2 days) of MEDI9253 dose level 2 over a maximum of 17 days, with a minimum of 5 days between each dose. After 14 days (+7 days) post the last dose of MEDI9253, participants will receive IV durvalumab at 1500 mg Q4W until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity, for up to 2 years.
  • Experimental: MEDI9253 Multiple Dose Level 3 + Durvalumab 1500 mg Q4W
    Participants will receive IV infusion of 3 weekly doses (±2 days) of MEDI9253 dose level 3 over a maximum of 17 days, with a minimum of 5 days between each dose. After 14 days (+7 days) post the last dose of MEDI9253, participants will receive IV durvalumab at 1500 mg Q4W until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity, for up to 2 years.
  • Experimental: MEDI9253 Multiple Dose Level 3+Durva 1500 mg Q4W Seq 3A-DESENS
    Participants will receive IV infusion of 3 weekly doses (±2 days) of MEDI9253 dose level 3 over a maximum of 17 days, with a minimum of 5 days between each dose (first dose was administered at dose level 2 while second and third doses were administered at dose level 3). After 14 days (+7 days) post the last dose of MEDI9253, participants will receive IV durvalumab at 1500 mg Q4W until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity, for up to 2 years.
  • Experimental: MEDI9253 Multiple Dose Level 3+Durva 1500 mg Q4W Conc3B-DESENS
    Participants will receive IV infusion of 3 weekly doses (±2 days) of MEDI9253 dose level 3 over a maximum of 17 days, with a minimum of 5 days between each dose (first dose was administered at dose level 2 while second and third doses were administered at dose level 3) along with IV infusion of durvalumab 1500 mg Q4W starting from Day 8 (on the same day of second dose of MEDI9253) until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity, for up to 2 years.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [ Time Frame: Day 1 through 76.14 weeks (maximum observed duration) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteSt LouisMissouri63110-
Research SiteBuffaloNew York14263-
Research SiteNew YorkNew York10032-
Research SiteNew YorkNew York10065-
Research SitePittsburghPennsylvania15232-

Find similar trials in St Louis, MO

By research site
Research Site· St Louis, MOResearch Site· Buffalo, NYResearch Site· New York, NYResearch Site· Pittsburgh, PA

Related Studies