Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Malignancies

Treatments: Drug: AZD9150, Durvalumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03394144

D5660C00017

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 20 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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 1.
• 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

Key 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 1 patient group

C1:AZD9150, C2:AZD9150+Durvalumab

Experimental group

Description:

After confirmed safety with Cohort 1, Cohort 2 will open

Treatment:

Drug: AZD9150, Durvalumab