NCT05367440

Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer

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)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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 Prostate Cancer.

Detailed description

The study consists of 2 parts, Part A and Part B. Part A consists of the dose escalation cohorts and will include patients with metastatic castration resistant prostate cancer (mCRPC) or metastatic castration-sensitive prostate cancer (mCSPC); Part B consists of dose expansion cohorts and will include patients with mCSPC only. Part A comprises 4 individual arms each evaluating the safety, tolerability, and preliminary efficacy of AZD5305 in combination with a specific new hormonal agent (NHA). Part B comprises up to 4 individual arms (arms to be opened at Sponsor's discretion) each investigating the preliminary efficacy and aims to further build on the safety data for the combination of AZD5305 with a specific NHA. Approximately 783 patients will be enrolled and screened to ensure the required number of evaluable patients in each part and arm are enrolled. For Part A, 356 patients may be screened to obtain up to approximately 308 patients that can be assigned to study treatments across all study arms (1 to 4). For Part B dose expansion cohorts, up to 427 patients may be screened to obtain up to approximately 360 patients that can be assigned to study treatments across all study arms (1 to 4). Study treatment administration will continue until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment occur.

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
DRUG	AZD5305	Patients will receive an oral dose of AZD5305 once daily
DRUG	Enzalutamide	Patients will receive an oral dose of Enzalutamide once daily
DRUG	Abiraterone Acetate	Patients will receive an oral dose of Abiraterone Acetate once daily
DRUG	Darolutamide	Patients will receive an oral dose of Darolutamide twice daily
DRUG	Apalutamide	Patients will receive an oral dose of Apalutamide once daily

Timeline

• Start date: 2022-06-02
• Primary completion: 2031-04-11
• Completion: 2031-04-11
• First posted: 2022-05-10
• Last updated: 2025-12-08

Locations

20 sites across 4 countries: United States, Australia, Italy, United Kingdom

Regulatory

• FDA-regulated drug study