NCT02900157

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2016

Typical duration for phase_1

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 2, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2020

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

3.5 years

First QC Date

September 2, 2016

Last Update Submit

January 13, 2021

Conditions

Advanced Solid Tumors

Keywords

Advanced Solid TumorImmunotherapyMEDI9090MEDI4736Durvalumab

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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 reporting serious adverse events

    Screening through 3 months after the 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

Study Arms (1)

MEDI9090

EXPERIMENTAL
Biological: MEDI9090Biological: Durvalumab

Interventions

MEDI9090BIOLOGICAL

MEDI9090 will be administered by IV infusion

MEDI9090
DurvalumabBIOLOGICAL

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

MEDI9090

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research Site

Scottsdale, Arizona, 85258, United States

Location

Research Site

Los Angeles, California, 90025, United States

Location

Research Site

Denver, Colorado, 80218, United States

Location

Research Site

Huntersville, North Carolina, 28078, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

Research Site

Kōtoku, 135-8550, Japan

Location

Research Site

Sapporo, 003-0804, Japan

Location

Research Site

Sunto-gun, 411-8777, Japan

Location

MeSH Terms

Interventions

durvalumab

Study Officials

  • MedImmune LLC

    MedImmune LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 14, 2016

Study Start

August 9, 2016

Primary Completion

January 23, 2020

Study Completion

January 23, 2020

Last Updated

January 14, 2021

Record last verified: 2021-01

Locations

JP(3)US(5)