A Phase I Study of AZD4635 in Japanese Patients With Advanced Solid Malignancies

• Status: Completed
• Trial end date: 2020-09-07
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I, open-label study to assess the safety, tolerability, pharmacokinetics and anti-tumor activity of AZD4635 in Japanese patients with advanced solid malignancies. This study consists of 2 cohorts, Cohort1 and Cohort2. At least 3 or up to 6 evaluable Japanese patients with advanced solid malignancies will be enrolled in Cohort1 and 6 evaluable patients will be enrolled in Cohort2.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

Major Inclusion Criteria:

• Adult subjects; age ≥ 20 years

• 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

Major 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

• 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