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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04613492
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : May 31, 2022
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumors Biological: MEDI9253 Biological: Durvalumab Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2, 2020
Estimated Primary Completion Date : November 7, 2025
Estimated Study Completion Date : November 7, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Single dose MEDI9253, sequential Durvalumab
Various dose level cohorts for single dose MEDI9253 with sequential Durvalumab dosing
Biological: MEDI9253
Participants will receive either Single dose MEDI9253 or Multiple Dose MEDI9253; sequentially or concurrent with Durvalumab

Biological: Durvalumab
Durvalumab treatment will be started sequentially or concurrently with MEDI9253

Experimental: Multiple dose MEDI9253, sequential Durvalumab
Various dose level cohorts for multiple dose MEDI9253 with sequential Durvalumab dosing;
Biological: MEDI9253
Participants will receive either Single dose MEDI9253 or Multiple Dose MEDI9253; sequentially or concurrent with Durvalumab

Biological: Durvalumab
Durvalumab treatment will be started sequentially or concurrently with MEDI9253

Experimental: Multiple dose MEDI9253, concurrent Durvalumab
Various dose level cohorts for multiple dose MEDI9253 with concurrent Durvalumab dosing.
Biological: MEDI9253
Participants will receive either Single dose MEDI9253 or Multiple Dose MEDI9253; sequentially or concurrent with Durvalumab

Biological: Durvalumab
Durvalumab treatment will be started sequentially or concurrently with MEDI9253




Primary Outcome Measures :
  1. 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 ]
    DLTs must be treatment related and documented as Adverse Events (AEs)

  2. Number of participants experiencing adverse events (AEs) /serious adverse events (SAEs) [ Time Frame: Informed consent through 90 days post last dose of study drug, estimated to be 6 months ]
    AEs graded by NCI CTCAE v5.0

  3. Number of participants experiencing adverse events (AEs) leading to discontinuation [ Time Frame: Informed consent through 90-Post last dose, estimated to be 6 months ]
    AEs graded per NCI CTCAE v5.0


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: From Day 1 through 90 days after the last dose of study drug, estimated to be 6 months ]
    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

  2. Duration of Response ( DoR) [ Time Frame: From Day 1 through 90 days after the last dose of study drug, estimated to be 6 months ]
    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

  3. Time to Response (TTR) [ Time Frame: From Day 1 through 90 days after the last dose of study drug, estimated to be 6 months ]
    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

  4. 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 ]
    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

  5. Progression Free Survival (PFS) [ Time Frame: From Day 1 through 90 days after the last dose of study drug, estimated to be 6 months ]
    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

  6. Overall Survival [ Time Frame: From Day 1 through study completion, estimated to be 1 year ]
    OS is defined as the time from first dose of treatment until documentation of death

  7. Number of participants with detectable viral genome copies in blood [ Time Frame: From Day 1 through 90 days ]
    Presence of Viremia. Viral genome copies in blood collected over time

  8. Number of participants who have immune changes in tumor microenvironment (TME) on MEDI9253 treatment [ Time Frame: From Day 1 through 90 days ]
    Determine if MEDI9253 alters the TME. CD8 T cell infiltration and/or PD-L1 expression in tumors pre- and post-dosing by immunohistochemistry (IHC)

  9. 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 ]
    Immunogenicity of MEDI9253. Markers of antiviral immune response (anti-MEDI9253 neutralizing antibodies)

  10. IL-12 plasma concentrations [ Time Frame: From Day 1 through 90 days ]
    IL-12 plasma concentrations collected over time



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 101 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613492


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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United States, California
Research Site Not yet recruiting
Santa Monica, California, United States, 90404
United States, Florida
Research Site Not yet recruiting
Miami, Florida, United States, 33136
United States, Iowa
Research Site Not yet recruiting
Iowa City, Iowa, United States, 52242
United States, Missouri
Research Site Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Research Site Recruiting
Buffalo, New York, United States, 14263
Research Site Recruiting
New York, New York, United States, 10032
Research Site Recruiting
New York, New York, United States, 10065
United States, North Carolina
Research Site Not yet recruiting
Chapel Hill, North Carolina, United States, 27514
United States, Pennsylvania
Research Site Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Research Site Not yet recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
Research Site Not yet recruiting
Greenville, South Carolina, United States, 29605
United States, Washington
Research Site Not yet recruiting
Seattle, Washington, United States, 98109
France
Research Site Not yet recruiting
Bordeaux, France, 33076
Research Site Not yet recruiting
Villejuif, France, 94800
Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04613492    
Other Study ID Numbers: D7880C00001
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Solid Tumors
Additional relevant MeSH terms:
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Neoplasms
Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents