A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies

AstraZeneca1 site in 1 country11 target enrollmentJanuary 30, 2018

ConditionsAdvanced Solid Malignancies

InterventionsAZD9150, Durvalumab

DrugsAZD9150, Durvalumab

Overview

Phase: Phase 1
Intervention: AZD9150, Durvalumab
Conditions: Advanced Solid Malignancies
Sponsor: AstraZeneca
Enrollment: 11
Locations: 1
Primary Endpoint: Safety and tolerability in terms of adverse events
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.

Registry

clinicaltrials.gov

Start Date

January 30, 2018

End Date

April 12, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female patients must be at least 20 years of age.
•Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or
•Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).
•Adequate organ and marrow function
•Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol

Exclusion Criteria

•Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.
•Patients must have completed any previous cancer-related treatments before enrolment.
•Has active or prior autoimmune disease within the past 2 years
•Has active or prior inflammatory bowel disease or primary immunodeficiency
•Undergone an organ transplant that requires use of immunosuppressive treatment
•Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG
•Prior exposure to AZD9150 or any other anti PD (L)1 antibody.

Arms & Interventions

C1:AZD9150, C2:AZD9150+Durvalumab

After confirmed safety with Cohort 1, Cohort 2 will open

Intervention: AZD9150, Durvalumab

Outcomes

Primary Outcomes

Safety and tolerability in terms of adverse events

Time Frame: From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.

Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters

Secondary Outcomes

Maximum plasma concentration (Cmax)(From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.)
Overall response rate(Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.)
Duration of Response(Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.)
Area under the plasma concentration-time curve (AUC)(From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.)