A Multi-arm, Open-label Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD5305 in Combination with New Hormonal Agents in Patients with Metastatic Prostate Cancer (PETRANHA)
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 Prostate Cancer.
- Histologically confirmed diagnosis of metastatic prostate cancer.
- Candidate for treatment with enzalutamide, abiraterone acetate, or darolutamide with documented current evidence of metastatic prostate cancer.
- Surgically or medically castrated.
- Patients with Metastatic Castrate Resistant Prostate Cancer (mCRPC) or Metastatic Hormone Sensitive Prostate Cancer (mHSPC).
- For Patients Recruited Specifically to Tumour Pharmacodynamic Cohorts:
- Patients must have at least 1 tumour suitable for paired biopsies
- Any previous treatment with a poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor, Lu-PSMA, platinum chemotherapy, docetaxel (for mHSPC patients).
- Radiotherapy within 4 weeks of the first dose of study treatment.