MEDI5083 Alone and in Combination With Durvalumab, Tremelimumab, and/or Docetaxel.

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-21

Study Completion Date

2020-06-23

Brief Summary

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The purpose of this study is to evaluate the safety, pharmacokinetics and Immunogenicity of Medi5083 alone or in combination with Durvalumab,Tremelimumab, and/or Docetaxel in adult subjects with advanced solid tumors.

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Detailed Description

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This is a global Phase 1, first-time-in-human, multicenter, dose-escalation and dose-expansion study of MEDI5083 alone or in combination with Durvalumab, Tremelimumab, and/or Docetaxel.

Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1

MEDI5083 monotherapy followed by Durvalumab monotherapy in subjects with advanced solid tumors

Group Type EXPERIMENTAL

MEDI5083 monotherapy

Intervention Type BIOLOGICAL

Dose-escalation MEDI5083 monotherapy followed by monotherapy with Durvalumab

Part 2

Sequential MEDI5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab in subjects with advanced solid tumors.

Group Type EXPERIMENTAL

MEID5083 with Durvalumab or Tremelimumab

Intervention Type BIOLOGICAL

Sequential Medi5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab

Part 3

Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel in subjects with IO refractory/relapsed 2/3L in NSCLC

Group Type EXPERIMENTAL

Medi5083 with Durvalumab and Docetaxel

Intervention Type BIOLOGICAL

Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel

Interventions

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MEDI5083 monotherapy

Dose-escalation MEDI5083 monotherapy followed by monotherapy with Durvalumab

Intervention Type BIOLOGICAL

MEID5083 with Durvalumab or Tremelimumab

Sequential Medi5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab

Intervention Type BIOLOGICAL

Medi5083 with Durvalumab and Docetaxel

Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years at the time of screening or age of consent according to local law
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
3. Histologically or cytologically confirmed metastatic or recurrent tumor types
4. Subjects who have received prior immunotherapy may be eligible
5. Subjects must have at least one measurable lesion
6. Consent to provide archival tumor tissue and pre/on-treatment biopsies
7. Adequate organ and marrow function
8. Consent to use one highly effective method of contraception

Exclusion Criteria

1. Receipt of any systemic anticancer therapy within 28 days prior to the first dose of MEDI5083
2. Concurrent enrollment in another clinical study
3. Active/prior autoimmune of inflammatory disorders
4. History of immunodeficiency, solid organ transplant, or tuberculosis
5. Known allergy/hypersensitivity to drug or components
6. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression
7. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI5083

Minimum Eligible Age

18 Years

Maximum Eligible Age

101 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No