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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-02

Study Completion Date

2024-05-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MEDI9253 Single Dose Level 1 + Durvalumab 1500 mg Q4W

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.

Group Type EXPERIMENTAL

MEDI9253

Intervention Type BIOLOGICAL

Participants will receive either single or multiple dose of MEDI9253; sequentially or concurrent with Durvalumab

Durvalumab

Intervention Type BIOLOGICAL

Participants will receive durvalumab treatment sequentially or concurrently with MEDI9253

MEDI9253 Single Dose Level 2 + Durvalumab 1500 mg Q4W

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.

Group Type EXPERIMENTAL

MEDI9253

Intervention Type BIOLOGICAL

Participants will receive either single or multiple dose of MEDI9253; sequentially or concurrent with Durvalumab

Durvalumab

Intervention Type BIOLOGICAL

Participants will receive durvalumab treatment sequentially or concurrently with MEDI9253

MEDI9253 Multiple Dose Level 2 + Durvalumab 1500 mg Q4W

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.

Group Type EXPERIMENTAL

MEDI9253

Intervention Type BIOLOGICAL

Participants will receive either single or multiple dose of MEDI9253; sequentially or concurrent with Durvalumab

Durvalumab

Intervention Type BIOLOGICAL

Participants will receive durvalumab treatment sequentially or concurrently with MEDI9253

MEDI9253 Multiple Dose Level 3 + Durvalumab 1500 mg Q4W

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.

Group Type EXPERIMENTAL

MEDI9253

Intervention Type BIOLOGICAL

Participants will receive either single or multiple dose of MEDI9253; sequentially or concurrent with Durvalumab

Durvalumab

Intervention Type BIOLOGICAL

Participants will receive durvalumab treatment sequentially or concurrently with MEDI9253

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

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.

Group Type EXPERIMENTAL

MEDI9253

Intervention Type BIOLOGICAL

Participants will receive either single or multiple dose of MEDI9253; sequentially or concurrent with Durvalumab

Durvalumab

Intervention Type BIOLOGICAL

Participants will receive durvalumab treatment sequentially or concurrently with MEDI9253

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

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.

Group Type EXPERIMENTAL

MEDI9253

Intervention Type BIOLOGICAL

Participants will receive either single or multiple dose of MEDI9253; sequentially or concurrent with Durvalumab

Durvalumab

Intervention Type BIOLOGICAL

Participants will receive durvalumab treatment sequentially or concurrently with MEDI9253

Interventions

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MEDI9253

Participants will receive either single or multiple dose of MEDI9253; sequentially or concurrent with Durvalumab

Intervention Type BIOLOGICAL

Durvalumab

Participants will receive durvalumab treatment sequentially or concurrently with MEDI9253

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

101 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No