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

Study Overview
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Brief Summary
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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.

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

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Biological: MEDI9090
* Biological: Durvalumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEDI9090<br> | Biological: MEDI9090<br>* MEDI9090 will be administered by IV infusion<br>Biological: Durvalumab<br>* Durvalumab as a single agent will be administered by IV infusion after patients have completed the prescribed doses of Medi9090.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Solid Tumor, Immunotherapy, MEDI9090, MEDI4736, Durvalumab