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)

Conditions

Metastatic Prostate Cancer

Brief summary

AZD5305 in combination with NHA: Number of participants with adverse events/ serious adverse events, AZD5305 in combination with NHA: Number of participants with Dose Limiting Toxicities (DLTs) [Part A], AZD5305 in combination with NHA: Changes from baseline in laboratory findings, physical examination, ECOG performance status, ECGs, and vital signs

Detailed description

PK Parameters: (AZD5305 monotherapy): Area Under the concentration Curve (AUC) of AZD5305, PK Parameters: (AZD5305 monotherapy): Maximum plasma concentration (Cmax) of AZD5305, PK Parameters: (AZD5305 monotherapy): Time to maximum concentration (tmax) of AZD5305;, PK Parameters: (AZD5305 in combination with NHA): AUC of AZD5305, PK Parameters: (AZD5305 in combination with NHA): Cmax of AZD5305, PK Parameters: (AZD5305 in combination with NHA): tmax of AZD5305;, Efficacy parameters: Objective response rate (ORR), Efficacy parameters: Duration of response (DoR), Efficacy parameters: Time to response (TTR), Efficacy parameters: Radiographic progression-free survival (rPFS), Efficacy parameters: Percentage change in target lesion size, Efficacy parameters: Proportion of participants with ≥ 50% PSA decrease, Efficacy parameters: Proportion of participants with ≥ 90% PSA decrease, Efficacy parameters: Proportion of patients with undetectable PSA (< 0.2 ng/mL) [Part B], Efficacy parameters: PSA progression free survival, Efficacy parameters: Homologous recombination repair gene mutation (HRRRm) (including BRCA1/2) and their relationship with clinical response [Part B], [Part A] PK parameters of Enzalutamide and Apalutamide in combination with AZD5305: AUC of enzalutamide and apalutamide, [Part A] PK parameters of Enzalutamide and Apalutamide in combination with AZD5305: Cmax of enzalutamide and apalutamide, [Part A] PK parameters of Enzalutamide and Apalutamide in combination with AZD5305: tmax of enzalutamide and apalutamide

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Interventions

DRUGErleada 60 mg film-coated tablets

DRUGXtandi - 40 mg soft capsules

DRUGSaruparib

DRUGNUBEQA 300 mg film-coated tablets

DRUGZYTIGA 500 mg film-coated tablets

DRUGPrednisone Mylan Pharma 5 mg compresse

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
AZD5305 in combination with NHA: Number of participants with adverse events/ serious adverse events, AZD5305 in combination with NHA: Number of participants with Dose Limiting Toxicities (DLTs) [Part A], AZD5305 in combination with NHA: Changes from baseline in laboratory findings, physical examination, ECOG performance status, ECGs, and vital signs	—

Secondary

Measure	Time frame
PK Parameters: (AZD5305 monotherapy): Area Under the concentration Curve (AUC) of AZD5305, PK Parameters: (AZD5305 monotherapy): Maximum plasma concentration (Cmax) of AZD5305, PK Parameters: (AZD5305 monotherapy): Time to maximum concentration (tmax) of AZD5305;, PK Parameters: (AZD5305 in combination with NHA): AUC of AZD5305, PK Parameters: (AZD5305 in combination with NHA): Cmax of AZD5305, PK Parameters: (AZD5305 in combination with NHA): tmax of AZD5305;, Efficacy parameters: Objective response rate (ORR), Efficacy parameters: Duration of response (DoR), Efficacy parameters: Time to response (TTR), Efficacy parameters: Radiographic progression-free survival (rPFS), Efficacy parameters: Percentage change in target lesion size, Efficacy parameters: Proportion of participants with ≥ 50% PSA decrease, Efficacy parameters: Proportion of participants with ≥ 90% PSA decrease, Efficacy parameters: Proportion of patients with undetectable PSA (< 0.2 ng/mL) [Part B], Efficacy parameters: P	—

Measure

Time frame

PK Parameters: (AZD5305 monotherapy): Area Under the concentration Curve (AUC) of AZD5305, PK Parameters: (AZD5305 monotherapy): Maximum plasma concentration (Cmax) of AZD5305, PK Parameters: (AZD5305 monotherapy): Time to maximum concentration (tmax) of AZD5305;, PK Parameters: (AZD5305 in combination with NHA): AUC of AZD5305, PK Parameters: (AZD5305 in combination with NHA): Cmax of AZD5305, PK Parameters: (AZD5305 in combination with NHA): tmax of AZD5305;, Efficacy parameters: Objective response rate (ORR), Efficacy parameters: Duration of response (DoR), Efficacy parameters: Time to response (TTR), Efficacy parameters: Radiographic progression-free survival (rPFS), Efficacy parameters: Percentage change in target lesion size, Efficacy parameters: Proportion of participants with ≥ 50% PSA decrease, Efficacy parameters: Proportion of participants with ≥ 90% PSA decrease, Efficacy parameters: Proportion of patients with undetectable PSA (< 0.2 ng/mL) [Part B], Efficacy parameters: P

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Countries

Italy

Outcome results

None listed