Clinical Trials /

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

NCT04613492

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of MEDI9253 in Combination With Durvalumab in Select Solid Tumors
  • Official Title: An Open-label, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MEDI9253, a Recombinant Newcastle Disease Virus Encoding Interleukin-12, in Combination With Durvalumab in Participants With Select Advanced/Metastatic Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: D7880C00001
  • NCT ID: NCT04613492

Conditions

  • Solid Tumors

Interventions

DrugSynonymsArms
MEDI9253Multiple dose MEDI9253, concurrent Durvalumab
DurvalumabMultiple dose MEDI9253, concurrent Durvalumab

Purpose

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.

Detailed Description

      Up to approximately 192 participants may be assigned to study intervention in the study
      across approximately 30 sites globally.
    

Trial Arms

NameTypeDescriptionInterventions
Single dose MEDI9253, sequential DurvalumabExperimentalVarious dose level cohorts for single dose MEDI9253 with sequential Durvalumab dosing
  • MEDI9253
  • Durvalumab
Multiple dose MEDI9253, sequential DurvalumabExperimentalVarious dose level cohorts for multiple dose MEDI9253 with sequential Durvalumab dosing;
  • MEDI9253
  • Durvalumab
Multiple dose MEDI9253, concurrent DurvalumabExperimentalVarious dose level cohorts for multiple dose MEDI9253 with concurrent Durvalumab dosing.
  • MEDI9253
  • Durvalumab

Eligibility Criteria

        Inclusion Criteria:

          1. Participant must be at least 18 years old at signing of informed consent.

          2. Body weight > 35 kg at screening

        Exclusion Criteria:

        1 Primary central nervous system (CNS) disease is excluded, as well as untreated or
        uncontrolled metastatic CNS involvement, leptomeningeal disease, or cord compression.

        NOTE: CNS disease that has been treated and stable/controlled for at least 3 months is
        permitted. Participants with CNS disease controlled via systemic steroids are not
        permitted.
      
Maximum Eligible Age:101 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with Dose Limiting Toxicities (DLTs) of the MEDI9253 during the dose escalation phase
Time Frame:Single dose cohorts: From Day 1 through 14 days Multiple dose cohorts: From Day 1 through 28 days
Safety Issue:
Description:DLTs must be treatment related and documented as Adverse Events (AEs)

Secondary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:From Day 1 through 90 days after the last dose of study drug, estimated to be 6 months
Safety Issue:
Description:ORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR). The endpoint of ORR according to RECIST v1.1, will be assessed by evaluation of the responses post baseline until progression or the start of subsequent anti-cancer therapy
Measure:Duration of Response ( DoR)
Time Frame:From Day 1 through 90 days after the last dose of study drug, estimated to be 6 months
Safety Issue:
Description:DoR is defined as duration from first documentation of confirmed objective response (OR) to the first documented progressive disease (PD) or death. Tumor assessments will be based on RECIST v1.1
Measure:Time to Response (TTR)
Time Frame:From Day 1 through 90 days after the last dose of study drug, estimated to be 6 months
Safety Issue:
Description:TTR is defined as the time from the first dose of treatment until first documentation of subsequently confirmed OR. Tumor assessments will be based on RECIST v1.1
Measure:Evaluate Disease Control Rate (DCR)
Time Frame:From Day 1 through 90 days after the last dose of study drug, estimated to be 6 months
Safety Issue:
Description:DCR is defined as the proportion of participants with confirmed CR or PR, or stable disease (SD). Tumor assessments will be based on RECIST v1.1
Measure:Progression Free Survival (PFS)
Time Frame:From Day 1 through 90 days after the last dose of study drug, estimated to be 6 months
Safety Issue:
Description:PFS is defined as the time from first dose of treatment until first documentation of PD or death. Tumor assessments will be based on RECIST v1.1
Measure:Overall Survival
Time Frame:From Day 1 through study completion, estimated to be 1 year
Safety Issue:
Description:OS is defined as the time from first dose of treatment until documentation of death
Measure:Number of participants with detectable viral genome copies in blood
Time Frame:From Day 1 through 90 days
Safety Issue:
Description:Presence of Viremia. Viral genome copies in blood collected over time
Measure:Number of participants who have immune changes in tumor microenvironment (TME) on MEDI9253 treatment
Time Frame:From Day 1 through 90 days
Safety Issue:
Description:Determine if MEDI9253 alters the TME. CD8 T cell infiltration and/or PD-L1 expression in tumors pre- and post-dosing by immunohistochemistry (IHC)
Measure:Number of participants with neutralizing antibodies to MEDI9253
Time Frame:From Day 1 through 90 days after the last dose of study drug, estimated to be 6 months
Safety Issue:
Description:Immunogenicity of MEDI9253. Markers of antiviral immune response (anti-MEDI9253 neutralizing antibodies)
Measure:IL-12 plasma concentrations
Time Frame:From Day 1 through 90 days
Safety Issue:
Description:IL-12 plasma concentrations collected over time

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AstraZeneca

Trial Keywords

  • Solid Tumors

Last Updated

April 8, 2021