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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02900157
• Other study ID #: D4190C00055
• Status: Completed
• Phase: Phase 1
• Start date: August 9, 2016
• Est. completion date: January 23, 2020

Study information

• Verified date: January 2021
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 23, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Biological:
• MEDI9090
MEDI9090 will be administered by IV infusion
• Durvalumab
Durvalumab as a single agent will be administered by IV infusion after patients have completed the prescribed doses of Medi9090.

Locations

Country	Name	City	State
Japan	Research Site	Koto-ku
Japan	Research Site	Sapporo-shi
Japan	Research Site	Sunto-gun
United States	Research Site	Denver	Colorado
United States	Research Site	Huntersville	North Carolina
United States	Research Site	Los Angeles	California
United States	Research Site	San Antonio	Texas
United States	Research Site	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects reporting infusion related reactions		First dose of study medication through 30 days after the first dose of study medication
Primary	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	Individual MEDI9090 concentrations		First dose of study medication through 3 months after the last dose of study medication
Secondary	Number of subjects reporting adverse events		Screening through 3 months after last dose of study medication
Secondary	Number of subjects reporting serious adverse events		Screening through 3 months after the last dose of study medication
Secondary	Number of subjects with vital sign abnormalities reported as adverse events		Screening through 3 months after the last dose of study medication
Secondary	Number of subjects with ECG abnormalities reported as adverse events		Screening through 3 months after the last dose of study medication