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

NCT03736473 | Completed Phase 1

• 1 other identifier: D6070C00006
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Malignancies

Outcome Measures

Primary Outcomes (1)

• Adverse event

  To assess the safety and tolerability, describe any dose-limiting toxicity (DLT) for MEDI9447

  From the informed consent to 90 days after the last dose

Study Arms (1)

MEDI9447 monotherapy

OTHER

Dose escalation of MEDI9447 monotherapy for patients with advanced solid malignancies

Drug: MEDI9447 (oleclumab)

Interventions

MEDI9447 (oleclumab) DRUG

MEDI9447 administered intravenously

MEDI9447 monotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Chūōku, 104-0045, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 9, 2018
• Study Start: November 7, 2018
• Primary Completion: June 19, 2019
• Study Completion: June 19, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-06

Locations

JP (1)