Brief Summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of AZD5305 when given in combination with new hormonal agents (NHAs) in patients with Metastatic Prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation Cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs.
Intervention / Treatment
- Drug: AZD5305
- Drug: Enzalutamide
- Drug: Abiraterone Acetate
- Drug: Darolutamide
- Drug: Apalutamide
Inclusion Criteria:
For whole study:
- Age ≥ 18 at the time of screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening.
- Histologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of metastatic prostate cancer.
- Candidate for treatment with enzalutamide, abiraterone acetate, darolutamide or apalutamide with documented current evidence of metastatic prostate cancer.
- Surgically or medically castrated.
- Adequate organ and marrow function.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group Performance Status (ECOG PS): 0-1 with no deterioration over the previous 2 weeks.
- Life expectancy ≥ 16 weeks.
- Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to approximately 6 months after the last dosethe amount of medication taken of study treatment .
For Patients Recruited Specifically to tumoura tissue mass that forms from groups of unhealthy cells Pharmacodynamic Cohorts:
• Patients must have at least 1 tumour suitable for paired biopsies
For Part A:
• Patients with Metastatic Castrate ion-Resistant Prostate Cancer (mCRPC) or Metastatic Castration Sensitive Prostate Cancer (mCSPC).
For Part B:
• Patients must have mCSPC (de novo or recurrent) with a baseline PSA value of ≥ 0.2 ng/mL