Advanced Solid Malignancies
Conditions
Interventions
investigational material(s)
Generic name etc : AZD9150, Durvalumab
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigatio
Sponsors
AstraZeneca KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| other - | — |
Secondary
| Measure | Time frame |
|---|---|
| safety - | — |
Countries
Japan
Outcome results
None listed