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

Advanced Solid Malignancies Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

Objectives:

Primary objective:

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

Secondary objective:

To determine the pharmacokinetics (PK) characteristics of MEDI9447 To determine the immunogenicity of MEDI9447 To evaluate candidate biomarker of MEDI9447 activity in archival tumor biopsy specimens To describe the preliminary antitumor activity of MEDI9447

Exploratory Objective:

To explore profile of biomarker status, with MEDI9447 treatment

Overall design:

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 (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. The total number of subjects will depend upon the available data in each cohort and Safety Review Committee (SRC)'s decision.

Study Period:

The study is expected to start in October 2018 and end in July 2019.

Number of Subjects:

Maximum 12 evaluable patients will be enrolled in this study.

Treatments and treatment duration:

Subjects will receive MEDI9447 on Day 1 and Day 15 in a 4-week cycle. Subjects participating in the study may continue to receive study treatment(s) as long as they are continuing to show clinical benefit, as judged by the Investigator, unless the subject has progressive disease (PD) with either clinical deterioration and/or no further benefit from treatment, experiences unacceptable toxicity, or should discontinue for any other reason. In such cases, the Investigator needs to consult with the sponsor and they agree to continue study treatment in advance.

Statistical methods:

The primary objective of this study is to assess the safety and tolerability profile of MEDI9447.

All safety data will be summarized using the safety analysis set (All subjects who received at least 1 dose of MEDI9447). Evaluations of safety and tolerability will include, but not be limited to, AEs, physical examinations, laboratory findings (including clinical chemistry, hematology, and urinalysis), vital signs (including blood pressure and pulse), and electrocardiograms using summary statistics.

For secondary and exploratory efficacy endpoints, all analyses will be descriptive, and no formal statistical testing will be performed. Data will be summarized and plotted appropriately according to data type.

PK concentration data for MEDI9447 will be listed for each subject and each dosing day, and summary statistics will be tabulated. Immunogenicity results will be listed by subject, and summaries of the number and percentage of subjects who develop detectable antidrug antibodies (ADAs) against MEDI9447 will be provided. The immunogenicity titre will be listed for samples confirmed positive for the presence of ADAs. Neutralizing ADAs may be reported for samples confirmed positive for the presence of ADAs.

All analyses and reporting will be conducted for each cohort. ;

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Neoplasms

• NCT number: NCT03736473
• Study type: Interventional
• Source: AstraZeneca
• Status: Completed
• Phase: Phase 1
• Start date: November 7, 2018
• Completion date: June 19, 2019