Clinical trial NCT04613492: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Solid Tumors
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-11-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 101
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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.

Primary outcomes:
measure: Number of participants with Dose Limiting Toxicities (DLTs) of the MEDI9253 during the dose escalation phase
timeFrame: Single dose cohorts: From Day 1 through 14 days Multiple dose cohorts: From Day 1 through 28 days
measure: Number of participants experiencing adverse events (AEs) /serious adverse events (SAEs)
timeFrame: Informed consent through 90 days post last dose of study drug, estimated to be 6 months
measure: Number of participants experiencing adverse events (AEs) leading to discontinuation
timeFrame: Informed consent through 90-Post last dose, estimated to be 6 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: From Day 1 through 90 days after the last dose of study drug, estimated to be 6 months
measure: Duration of Response ( DoR)
timeFrame: From Day 1 through 90 days after the last dose of study drug, estimated to be 6 months
measure: Time to Response (TTR)
timeFrame: From Day 1 through 90 days after the last dose of study drug, estimated to be 6 months
measure: Evaluate Disease Control Rate (DCR)
timeFrame: From Day 1 through 90 days after the last dose of study drug, estimated to be 6 months
measure: Progression Free Survival (PFS)
timeFrame: From Day 1 through 90 days after the last dose of study drug, estimated to be 6 months
measure: Overall Survival
timeFrame: From Day 1 through study completion, estimated to be 1 year
measure: Number of participants with detectable viral genome copies in blood
timeFrame: From Day 1 through 90 days
measure: Number of participants who have immune changes in tumor microenvironment (TME) on MEDI9253 treatment
timeFrame: From Day 1 through 90 days
measure: Number of participants with neutralizing antibodies to MEDI9253
timeFrame: From Day 1 through 90 days after the last dose of study drug, estimated to be 6 months
measure: IL-12 plasma concentrations
timeFrame: From Day 1 through 90 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Buffalo
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Bordeaux
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Villejuif
country: France
facility: Research Site
Study officials:
References: