Skip to main content
OpenTrials
Completed

NCT Number: NCT03089645

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Solid Tumors

Age range

18 year–101 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Clayton, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

MEDI5083 monotherapy

Biological

Dose-escalation MEDI5083 monotherapy followed by monotherapy with Durvalumab

MEID5083 with Durvalumab or Tremelimumab

Biological

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

Medi5083 with Durvalumab and Docetaxel

Biological

Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel

Primary outcomes

  1. Number of participants with Adverse Events (AEs) as a measure of safety

    Time frame: From the time of consent through 120 days after last treatment

    Safety Endpoint

  2. Number of participants with Serious Adverse Events (SAEs) as a measure of safety

    Time frame: From the time of consent through 120 days after last treatment

    Safety Endpoint

  3. Number of participants with Dose Limiting Toxicities (DLTs) as a measure of safety

    Time frame: From the time of first dose through 28 days thereafter

    Safety Endpoint

  4. The Maximum Tolerated Dose (MTD) or Highest Protocol-Defined Dose

    Time frame: From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)

    Safety Endpoint

  5. Discontinuation of investigational products due to toxicity

    Time frame: From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)

    Safety Endpoint

  6. Clinically significant alterations in vital signs, laboratory parameters, physical examination, and electrocardiogram (ECG) results.

    Time frame: From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)

    Safety Endpoint

  7. Antitumor activity endpoints OR, based on RECIST v1.1

    Time frame: Part 3

    Safety Endpoint

Secondary outcomes

  1. Serum MEDI5083 concentration levels

    Time frame: From the time of first dose through 57 days after first treatment

    Pharmacokinetics (PK)

  2. Reduction in peripheral blood CD19+ B cells

    Time frame: From the time of first dose through 57 days after first treatment

    Pharmacodynamics (PD)

  3. Incidence of anti-drug antibody (ADA) responses to MEDI5083

    Time frame: From the time of first dose through 2 years after last treatment

    Immunogenicity

  4. Objective Response Rate (ORR)

    Time frame: From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)

    Clinical Activity Endpoint

  5. Progression Free Survival (PFS) at 6 months (PFS-6)

    Time frame: From the time of first dose until 6 months after the last subject is dosed

    Clinical Activity Endpoint

  6. Overall Survival (OS)

    Time frame: From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)

    Clinical Activity Endpoint

  7. Disease Control Rate (DCR)

    Time frame: From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)

    Clinical Activity Endpoint

  8. Duration of Response (DoR)

    Time frame: From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)

    Clinical Activity Endpoint

  9. Serum Durvalumab concentration levels collected over time

    Time frame: From the time of first dose through 29 days after first treatment

    Pharmacokinetics (PK)

  10. Incidence of anti-drug antibody (ADA) responses to Durvalumab

    Time frame: From the time of first dose through 2 years after last treatment

    Immunogenicity

  11. Incidence of anti-drug antibody (ADA) responses to tremelilumab

    Time frame: From the time of first dose through 2 years after last treatment

    Immunogenicity

  12. Serum tremelimumab concentration levels collected over time

    Time frame: From the time of first dose through 57 days after first treatment

    Pharmacodynamics (PD)

  13. PD of MEDI5083 alone and in combination with Durvalumab and tremelimumab

    Time frame: From the time of first dose through 57 days after first treatment

    Pharmacodynamics (PD)

  14. Safety and tolerability of MEDI5083 with durvalumamb and docetaxel and in subjects with IO relapsed/refractory 2/3L NSCLC

    Time frame: From the time of first dose through 57 days after first treatment

    Safety

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

A Phase 1 First Time in Human Study to Evaluate the Safety, Pharmacokinetics and Immunogenicity of MEDI5083 Alone or in Combination With Durvalumab, Tremelimumab, and/or Docetaxel in Advanced Solid Tumors

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 24, 2017
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.