Advanced Solid Malignancies
Conditions
Interventions
investigational material(s)
Generic name etc : AZD4635
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material
Sponsors
AstraZeneca KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult subjects; age 20 years or more - Histologically or cytological confirmation of a solid, malignant tumor, excluding central nervous system (CNS) tumors and lymphoma, that is refractory to standard therapy or for which no standard of care regimen currently exists - Patients must have either at least one lesion that can be evaluable using RECIST v1.1 or patients with mCRPC must have measurable prostate specific antigen above normal limits (per local ranges) - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Normotensive or well controlled blood pressure, with or without current antihypertensive treatment - Females of child-bearing potential must use 2 highly effective methods of contraception - Male patients should be willing to use barrier contraception
Exclusion criteria
Exclusion criteria: - Any investigational medicinal product or other systemic anticancer treatment within at least 4 weeks prior to the first dose of study treatment, or within 8 weeks after immunotherapy or other long half-life antibody therapy, whichever is the most appropriate and as judged by the Investigator - Evidence of recent or significant cardiovascular disease - Unresolved toxicities from prior therapy greater than CTCAE Grade 1 at starting study treatment - History of seizures, CNS tumors or CNS metastasis - Active or prior documented autoimmune or inflammatory disorders within the past 3 years to the start of treatment - Patients with prior Grade3 immune-mediated reactions or more - Evidence of severe or uncontrolled systemic diseases - Inadequate bone marrow reserve or organ function - Refractory nausea and vomiting, chronic gastrointestinal diseases, or previous significant bowel resection that would preclude adequate absorption of AZD4635 - History of hypersensitivity to AZD4635 or drugs with a similar chemical structure or class to AZD4635 - Judgment by the Investigator that the patient should not participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety - | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacodynamics - | — |
Countries
Japan
Outcome results
None listed