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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Metastatic Prostate Cancer

In brief

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.

Key facts

Study ID: NCT05367440
Run by: AstraZeneca
People needed: 174
Starts: 2022-06-02
Expected to finish: 2031-04-11
Last updated by the study team: 2026-06-01

Who can join

Age: 18 and older, up to 130. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

For whole study:
Age ≥ 18 at the time of screening.
Histologically confirmed diagnosis 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 Oncology 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 dose of study treatment .
For Patients Recruited Specifically to tumour 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

You may not qualify if…

For Part A mCRPC patients only:
Any previous treatment with a new hormonal agent (NHA), poly (adenosine diphosphateribose) polymerase inhibitor (PARPi), Lutetium prostate-specific membrane antigen (Lu-PSMA), platinum chemotherapy
Patients recruited to the PDc cohorts should not have received a prior use of new hormonal agents (NHA).
For Part A and Part B mCSPC Patients:
Any previous treatment with a PARPi, platinum, NHA, Immuno-oncology (IO), radiopharmaceutical therapy, or prior treatment with docetaxel in mCSPC setting.
Concomitant use of medications or herbal supplements known to be:
Strong and moderate CYP3A4 inducers/inhibitors (applies for all arms)
For Arm 1 (enzalutamide) patients: Strong CYP2C8 inhibitors
For Arm 3 (darolutamide) patients: Strong P-glycoprotein inducers
Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes.
Treatment with any of the following:
Any investigational agents or study interventions from a previous clinical study within 5 half lives or 3 weeks (whichever is longer) of the first dose of study treatment.
Any other anticancer treatment within the following time periods prior to the first dose of study treatment: (i) Cytotoxic and non-cytotoxic treatment: 3 weeks or 5 half-lives (whichever is shorter). (ii) Biological products including immuno-oncology agents: 4 weeks before enrolment.
Any live virus or bacterial vaccine within 28 days of the first dose of study treatment.
Any concurrent anticancer therapy or concurrent use of prohibited medications.
Major surgery within 4 weeks prior to the first dose of study treatment.
Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.
With the exception of alopecia, and peripheral neuropathy; any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of study enrolment.
Any history of persisting (> 2 weeks) severe pancytopenia.
Spinal cord compression, or brain metastases unless asymptomatic and treated and stable.
Any evidence of severe or uncontrolled systemic diseases, including, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
Patients with any known predisposition to bleeding (eg, active peptic ulceration, recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy.
Any clinically significant cardiac disorders including QT prolongation, abnormal electrocardiogram (ECG).
Any clinically significant cardiovascular diseases including symptomatic heart failure, uncontrolled hypertension, acute coronary syndrome, cardiomyopathy, valvular heart disease, atrial fibrillation, stroke.
Patients with history of myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML).

Where it is running

Research Site — Detroit, Michigan, United States
Research Site — Detroit, Michigan, United States
Research Site — Syracuse, New York, United States
Research Site — Myrtle Beach, South Carolina, United States
Research Site — Houston, Texas, United States
Research Site — Houston, Texas, United States
Research Site — Camperdown, Australia
Research Site — Darlinghurst, Australia
Research Site — East Melbourne, Australia
Research Site — Heidelberg, Australia
Research Site — Melbourne, Australia
Research Site — St Leonards, Australia
Research Site — Candiolo, Italy
Research Site — Milan, Italy
Research Site — Orbassano, Italy
Research Site — Padova, Italy
Research Site — Cambridge, United Kingdom
Research Site — Glasgow, United Kingdom
Research Site — Manchester, United Kingdom
Research Site — Plymouth, United Kingdom

Full record on ClinicalTrials.gov

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