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

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Biological: MEDI9090; Biological: Durvalumab

• Registration Number: NCT02900157
• Lead Sponsor: MedImmune LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-09
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-14
• Primary Completion: 2020-01-23
• Study Completion: 2020-01-23
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MEDI9090	MEDI9090	-
MEDI9090	Durvalumab	-

Primary Outcome Measures

Name	Time	Method
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
Number of subjects reporting infusion related reactions	First dose of study medication through 30 days after the first dose of study medication

Secondary Outcome Measures

Name	Time	Method
Number of subjects reporting adverse events	Screening through 3 months after 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 with vital sign abnormalities reported as adverse events	Screening through 3 months after the 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 ECG abnormalities reported as adverse events	Screening through 3 months after the last dose of study medication

Trial Locations

Locations (1)

Research Site; 🇯🇵 Sunto-gun, Japan