A Phase I Study of MEDI9447 (Oleclumab) in Japanese Patients

• Status: Completed
• Trial end date: 2019-06-19
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MEDI9447 in Japanese patients with advanced solid malignancies.This study consists of 2 cohorts. Cohort 1 (dose level 1) and Cohort 2 (dose level 2). At least 3 or up to 6 evaluable Japanese patients with advanced solid malignancies will be enrolled in each cohort.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

Major Inclusion Criteria:

• Adult subjects; age ≥ 20 years

• 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

• Adequate organ function

• Body weight ≥ 35 kg

Major 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 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 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