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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Biological: MEDI9253; Biological: Durvalumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04613492

D7880C00001

2020-002294-96 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 101 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Single dose MEDI9253, sequential Durvalumab

Experimental group

Description:

Various dose level cohorts for single dose MEDI9253 with sequential Durvalumab dosing

Treatment:

Biological: Durvalumab

Biological: MEDI9253

Multiple dose MEDI9253, sequential Durvalumab

Experimental group

Description:

Various dose level cohorts for multiple dose MEDI9253 with sequential Durvalumab dosing;

Treatment:

Biological: Durvalumab

Biological: MEDI9253

Multiple dose MEDI9253, concurrent Durvalumab

Experimental group

Description:

Various dose level cohorts for multiple dose MEDI9253 with concurrent Durvalumab dosing.

Treatment:

Biological: Durvalumab

Biological: MEDI9253