Clinical trial NCT02900157: Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors
Official title: A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Advanced Solid Tumor
Immunotherapy
MEDI9090
MEDI4736
Durvalumab
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2016-09-14
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects reporting infusion related reactions
timeFrame: First dose of study medication through 30 days after the first dose of study medication
measure: Number of subjects that develop changes in detectable antidrug antibodies to MEDI9090
timeFrame: First dose of study medication through 6 months after the last dose of study medication
Secondary outcomes:
measure: Individual MEDI9090 concentrations
timeFrame: First dose of study medication through 3 months after the last dose of study medication
measure: Number of subjects reporting adverse events
timeFrame: Screening through 3 months after last dose of study medication
measure: Number of subjects reporting serious adverse events
timeFrame: Screening through 3 months after the last dose of study medication
measure: Number of subjects with vital sign abnormalities reported as adverse events
timeFrame: Screening through 3 months after the last dose of study medication
measure: Number of subjects with ECG abnormalities reported as adverse events
timeFrame: Screening through 3 months after the last dose of study medication
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Huntersville
country: United States
facility: Research Site
state: North Carolina
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Koto-ku
country: Japan
facility: Research Site
city: Sapporo-shi
country: Japan
facility: Research Site
city: Sunto-gun
country: Japan
facility: Research Site
Study officials:
affiliation: MedImmune LLC
name: MedImmune LLC
role: STUDY_DIRECTOR
References: