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

MedImmune

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Biological: MEID5083 with Durvalumab or Tremelimumab; Biological: MEDI5083 monotherapy; Biological: Medi5083 with Durvalumab and Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03089645

D6840C00001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 101 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

Part 1

Experimental group

Description:

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

Treatment:

Biological: MEDI5083 monotherapy

Part 2

Experimental group

Description:

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

Treatment:

Biological: MEID5083 with Durvalumab or Tremelimumab

Part 3

Experimental group

Description:

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

Treatment:

Biological: Medi5083 with Durvalumab and Docetaxel