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New drug combo aims to tackle Hard-to-Treat prostate cancer

NCT ID NCT07336446

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study tests a new drug called AZD9750, alone or with another drug (saruparib), in 300 men with metastatic prostate cancer that has progressed despite standard treatments. The goal is to check safety, find the right dose, and see if it can lower PSA levels, a marker of cancer activity. It is an early-stage trial, so the main focus is on safety and tolerability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD9750 (a drug that targets and breaks down the androgen receptor) and saruparib (a PARP1 inhibitor)
What this could lead to
If successful, this could lead to a new treatment option for men with metastatic prostate cancer that has stopped responding to standard hormone therapy.
What could go wrong
This is an early-phase trial (first-in-human) with only 300 participants, so the drug may not prove effective or may have unexpected side effects. Results may not apply to all prostate cancer patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* Inclusion Criteria: * 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: 1. PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination. 2. Radiographic progression of soft tissue disease by RECIST v1.1 with or without PSA progression. 3. Radiographic progression of bone metastasis with 2 or more documented new bone lesions on a bone scan with or without PSA progression. * 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 Criteria: * 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. Other protocol-defined inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

Kennedy disease metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Duarte, California, 91010, United States

  • Research Site

    NOT_YET_RECRUITING

    San Francisco, California, 94143, United States

  • Research Site

    NOT_YET_RECRUITING

    Tampa, Florida, 33612, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Research Site

    RECRUITING

    St Louis, Missouri, 63108, United States

  • Research Site

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Research Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Research Site

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Research Site

    RECRUITING

    Melbourne, 3000, Australia

  • Research Site

    RECRUITING

    Calgary, Alberta, T2N 5G2, Canada

  • Research Site

    NOT_YET_RECRUITING

    Vancouver, British Columbia, V5Z 1H7, Canada

  • Research Site

    NOT_YET_RECRUITING

    Chengdu, 610041, China

  • Research Site

    NOT_YET_RECRUITING

    Chūōku, 104-0045, Japan

  • Research Site

    RECRUITING

    Kashiwa, 227-8577, Japan

  • Research Site

    NOT_YET_RECRUITING

    Amsterdam, 1066CX, Netherlands

  • Research Site

    RECRUITING

    Rotterdam, 3015AA, Netherlands

  • Research Site

    RECRUITING

    Barcelona, 8035, Spain

  • Research Site

    RECRUITING

    Cambridge, CB2 2QQ, United Kingdom

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