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AZD9750 for Metastatic Prostate Cancer

This study is testing a new treatment called AZD9750, sometimes combined with another drug called AZD5305, for men with prostate cancer that has spread (metastatic prostate cancer). The main goals are to understand how safe AZD9750 is and what side effects it might cause, as well as to see how well it works. The study is looking for men aged 18 or older who have been diagnosed with metastatic prostate cancer and whose disease has progressed. Success in this study will be measured by how many participants experience side effects, especially severe ones, and how many have to stop treatment due to side effects. The current status of this study is unclear, and it plans to enroll about 300 participants.

Study design
This is a Phase I/II, open-label study, meaning you and your doctors will know which treatment you are receiving. It is a multicenter study, and it plans to enroll about 300 participants.
What's involved
Treatment continues until your disease progresses, you experience unacceptable side effects, or you choose to stop. The study will monitor for side effects from your first dose up to 37 days after your last dose.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for side effects for up to 37 days after your last dose of study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07336446

A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer Drugs

Recruiting
PHASE1Ages 18+InterventionalTreatment
AstraZeneca
~300 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:AZD9750AZD5305

At a glance

Recruiting sites
12 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only)
Measured over From first dose of study intervention to 28 days post first dose
+8 more outcomes measured

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

18 sites across 15 states
California2
Japan2
Netherlands2
Florida1
Massachusetts1
Missouri1
South Carolina1
Tennessee1

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant must be ≥18 years or the legal age at the time of signing the informed consent form.
Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
Documented metastatic disease.
Serum testosterone levels ≤ 50 ng/dL.
Evidence of disease progression with one of the following:
ECOG performance status score of 0 or 1.
Adequate bone marrow and organ function.
Part A (Module 1)
(a) Part A1 dose escalation: at least 1 prior ARPI and, if applicable, at least 1 taxane-based chemotherapy (regardless of whether in HSPC or CRPC setting).
(b) Part A2 backfill: at least 1 but no more than 2 prior ARPIs and, if applicable, at least 1 but no more than 2 prior taxane-based chemotherapies (regardless of whether in HSPC or CRPC setting).
Part B (Module 1)
(a) B1/B2 dose optimization/expansion: at least 1 but no more than 2 prior ARPIs and, if applicable, at least 1 but no more than 2 prior taxane-based chemotherapies (regardless of whether in HSPC or CRPC setting).
(b) B3 dose expansion (no taxane cohort): at least 1 but no more than 2 prior ARPIs for metastatic prostate cancer (regardless of whether in HSPC or CRPC setting). No prior taxane is allowed for inclusion in this cohort.

Exclusion

Participants with pathological finding consistent with any presence of small cell carcinoma, predominant neuroendocrine carcinoma, or any predominant histology other than prostate adenocarcinoma.
Brain metastases, or spinal cord compression.
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.
Active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism of AZD9750 and relevant combination IMPs.
Participants with any known predisposition to bleeding (eg, active peptic ulceration, recent \[within 6 months\] hemorrhagic stroke, proliferative diabetic retinopathy).
Prior treatment with an AR-PROTAC.

What this trial measures

  • Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only)From first dose of study intervention to 28 days post first dose

    To evaluate the safety and tolerability and determine the MTD and/or the RDE(s)/RP2D of AZD9750 as a monotherapy and in combination with other anticancer agents in participants with mCRPC. A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.

  • Number of participants with Adverse Events and Serious Adverse EventsFrom first dose of study intervention up to 37 days after the last dose of study treatment

    The number of participants with adverse events and with serious adverse events will be assessed.

  • Number of participants with Adverse Events leading to discontinuation of study interventionFrom first dose of study intervention up to 37 days after the last dose of study treatment

    The number of participants with clinically significant changes from baseline in vital signs will be assessed.

  • Clinically significant changes from baseline in vital signs.From first study dose up to 37 days after the last dose of study treatment

    The number of participants with clinically significant changes from baseline in vital signs will be assessed.

  • Clinically significant changes from baseline in physical examination.From first dose of study intervention up to 37 days after the last dose of study treatment

    The number of participants with clinically significant changes from baseline in physical examination will be assessed.

  • Clinically significant changes from baseline in ECOG PS.From first dose of study intervention up to 37 days after the last dose of study treatment

    The number of participants with clinically significant changes from baseline in ECOG PS will be assessed.

  • Clinically significant changes from baseline in ECGs.From first dose of study intervention up to 37 days after the last dose of study treatment

    The number of participants with clinically significant changes from baseline in ECGs will be assessed.

  • Clinically significant changes from baseline in laboratory parameters.From first dose of study intervention up to 37 days after the last dose of study treatment

    The number of participants with clinically significant changes from baseline in laboratory parameters will be assessed.

  • Proportion of participants achieving a ≥50% decrease in PSA from baseline (PSA50) (Part B only)From first dose of study intervention up to 14 days after the last dose of study treatment

    To evaluate the preliminary antitumour efficacy of AZD9750 as monotherapy and in combination with other anticancer agents in participants with mCRPC.