Advanced Solid Malignancies
Conditions
Interventions
investigational material(s)
Generic name etc : MEDI9447(Oleclumab)
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigatio
Sponsors
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult subjects; age 20 years or more - Has a histologically confirmed solid malignancy that is refractory to standard therapy or for which no standard of care regimen currently exists - Subjects must have at least 1 lesion that is measureable using RECIST v1.1 - All subjects must consent to provide archived tumor specimens for biomarker studies - ECOG Performance Status of 0 or 1 - Life expectancy 12 weeks or more - Adequate organ function - Body weight 35 kg or more
Exclusion criteria
Exclusion criteria: - Patients must have completed any previous cancer-related treatments before enrollment - Prior treatment with CD73 antagonist, tumor necrosis factor receptor superfamily agonists - All CTLA-4, PD-1, or PD-L1 antagonists related-AEs must have resolved to NCI CTCAE v4.03 Grade 1 or less or baseline prior to screening and not worsened before the first dose of study drug - Must not have required the use of additional immunosuppression other than corticosteroids for the management of an CTLA-4, PD-1, or PD-L1 related AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day - Known allergy or hypersensitivity to the study drug, its compounds, or agents similar biologic composition - History of more than one event of IRR requiring permanent discontinuation of IV drug treatment - History of severe drug allergies or anaphylaxis to 2 or more food products or medicine - Cardiac or peripheral vascular disease - NCI CTCAE v4.03 Grade 3 or greater edema - Uncontrolled massive ascites or pleural effusion - History of NCI CTCAE v4.03 Grade 3 or greater thromboembolic events within 3 months prior to the first dose of study drug or thromboembolic event of any grade with ongoing symptoms - Active tuberculosis - Patients with history of, or current ILD - Active or prior documented autoimmune within the past 3 years prior to the start of treatment - Untreated or unstable CNS metastatic disease, leptomeningeal disease, or cord compression - Concurrent enrollment in another clinical study - Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment - Toxicities from prior anticancer therapy that have not resolved to NCI CTCAE v4.03 Grade 1 or less or baseline prior to the first dose of study drug - History of primary immunodeficiency or solid organ transplantation - Active hepatitis B, hepatitis C, or HIV - Females who are pregnant, lactating, or intend to become pregnant during their participation in the study - Other invasive malignancy within 2 years prior to the first dose of study drug - Uncontrolled concomitant illnes - Judgment by the Investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements - Involvement in the planning and/or conduct of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety - | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics pharmacodynamics - | — |
Countries
Japan
Outcome results
None listed