A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of MEDI9447 (Oleclumab) in Japanese Patients with Advanced Solid Malignancies
- Conditions
- Advanced Solid Malignancies
- Registration Number
- JPRN-jRCT2080224133
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 12
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>-
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>pharmacodynamics<br>-