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
- Conditions
- Advanced Solid Malignancies
- Registration Number
- JPRN-jRCT2080223819
- Lead Sponsor
- AstraZeneca KK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 9
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method other<br>-
- Secondary Outcome Measures
Name Time Method safety<br>-