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OpenTrials
Completed

NCT Number: NCT02900157

Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors

This is an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI9090 in adult subjects with advanced solid tumors.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Kōtoku, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female subjects
  • 18 years and older
  • Must have histologic documentation of advanced solid tumors
  • Must have received and have progressed, are refractory or, intolerant to standard therapy and must not have a curative therapy option

Exclusion criteria

  • Concurrent enrollment in another clinical study
  • Prior participation in clinical studies that include durvalumab alone or in combination
  • Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment

Treatment and study plan

MEDI9090

Biological

MEDI9090 will be administered by IV infusion

Durvalumab

Biological

Durvalumab as a single agent will be administered by IV infusion after patients have completed the prescribed doses of Medi9090.

Primary outcomes

  1. Number of subjects reporting infusion related reactions

    Time frame: First dose of study medication through 30 days after the first dose of study medication

  2. Number of subjects that develop changes in detectable antidrug antibodies to MEDI9090

    Time frame: First dose of study medication through 6 months after the last dose of study medication

Secondary outcomes

  1. Individual MEDI9090 concentrations

    Time frame: First dose of study medication through 3 months after the last dose of study medication

  2. Number of subjects reporting adverse events

    Time frame: Screening through 3 months after last dose of study medication

  3. Number of subjects reporting serious adverse events

    Time frame: Screening through 3 months after the last dose of study medication

  4. Number of subjects with vital sign abnormalities reported as adverse events

    Time frame: Screening through 3 months after the last dose of study medication

  5. Number of subjects with ECG abnormalities reported as adverse events

    Time frame: Screening through 3 months after the last dose of study medication

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2016
Registry last updated
Jan 14, 2021

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.

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