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

AstraZeneca

Status and phase: Terminated; 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 6 patient groups

MEDI9253 Single Dose Level 1 + Durvalumab 1500 mg Q4W

Experimental group

Description:

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.

Treatment:

Biological: Durvalumab

Biological: MEDI9253

MEDI9253 Single Dose Level 2 + Durvalumab 1500 mg Q4W

Experimental group

Description:

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.

Treatment:

Biological: Durvalumab

Biological: MEDI9253

MEDI9253 Multiple Dose Level 2 + Durvalumab 1500 mg Q4W

Experimental group

Description:

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.

Treatment:

Biological: Durvalumab

Biological: MEDI9253

MEDI9253 Multiple Dose Level 3 + Durvalumab 1500 mg Q4W

Experimental group

Description:

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.

Treatment:

Biological: Durvalumab

Biological: MEDI9253

MEDI9253 Multiple Dose Level 3+Durva 1500 mg Q4W Seq 3A-DESENS

Experimental group

Description:

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.

Treatment:

Biological: Durvalumab

Biological: MEDI9253

MEDI9253 Multiple Dose Level 3+Durva 1500 mg Q4W Conc3B-DESENS

Experimental group

Description:

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.

Treatment:

Biological: Durvalumab

Biological: MEDI9253