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

Sponsor

MedImmune LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT02900157

Collaborator

(none)

Enrollment

Locations

Arm

41.5

Actual Duration (Months)

5.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Biological: MEDI9090 Biological: Durvalumab	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 9, 2016

Actual Primary Completion Date :

Jan 23, 2020

Actual Study Completion Date :

Jan 23, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Scottsdale	Arizona	United States	85258
2	Research Site	Los Angeles	California	United States	90025
3	Research Site	Denver	Colorado	United States	80218
4	Research Site	Huntersville	North Carolina	United States	28078
5	Research Site	San Antonio	Texas	United States	78229
6	Research Site	Koto-ku		Japan	135-8550
7	Research Site	Sapporo-shi		Japan	003-0804
8	Research Site	Sunto-gun		Japan	411-8777