Advanced Solid Tumors
Conditions
Keywords
Advanced Solid Tumor, Immunotherapy, MEDI9090, MEDI4736, Durvalumab
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.
Interventions
BIOLOGICALMEDI9090
MEDI9090 will be administered by IV infusion
BIOLOGICALDurvalumab
Durvalumab as a single agent will be administered by IV infusion after patients have completed the prescribed doses of Medi9090.
Sponsors
MedImmune LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of subjects reporting serious adverse events | Screening through 3 months after the 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 ECG abnormalities reported as 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 reporting adverse events | Screening through 3 months after last dose of study medication |
Countries
Japan, United States
Outcome results
None listed