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

A Phase 1 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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Biological: MEDI9090; Biological: Durvalumab

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Koto-ku, Japan, 135-8550
    • Research Site
  • Sapporo-shi, Japan, 003-0804
    • Research Site
  • Sunto-gun, Japan, 411-8777
    • Research Site
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Research Site
  • California
    • Los Angeles, California, United States, 90025
      • Research Site
  • Colorado
    • Denver, Colorado, United States, 80218
      • Research Site
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Research Site
  • Texas
    • San Antonio, Texas, United States, 78229
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MEDI9090	Biological: MEDI9090; MEDI9090 will be administered by IV infusion; Biological: Durvalumab; Durvalumab as a single agent will be administered by IV infusion after patients have completed the prescribed doses of Medi9090.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects reporting infusion related reactions	First dose of study medication through 30 days after the first dose of study medication
Number of subjects that develop changes in detectable antidrug antibodies to MEDI9090	First dose of study medication through 6 months after the last dose of study medication

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of subjects reporting serious adverse events	Screening through 3 months after the last dose of study medication
Individual MEDI9090 concentrations	First dose of study medication through 3 months after the last dose of study medication
Number of subjects reporting adverse events	Screening through 3 months after last dose of study medication
Number of subjects with vital sign abnormalities reported as adverse events	Screening through 3 months after the last dose of study medication
Number of subjects with ECG abnormalities reported as adverse events	Screening through 3 months after the last dose of study medication

Collaborators and Investigators

• Sponsor: MedImmune LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2016
• Primary Completion (Actual): January 23, 2020
• Study Completion (Actual): January 23, 2020

Study Registration Dates

• First Submitted: September 2, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Immunotherapy; Advanced Solid Tumor; Durvalumab; MEDI4736; MEDI9090
• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Durvalumab
• Other Study ID Numbers: D4190C00055