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ACTIVE NOT RECRUITINGPhase1/Phase2

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

Sponsor: AstraZeneca

NCT ID: NCT07336446

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AZD9750 (drug), AZD5305 (drug)
How long the study runs
Study runs about 10 months (dates as stated)
About the drug or intervention
AZD9750 — drug: AR-PROTAC · AZD5305 — drug: PARP1-selective inhibitor
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Male
Number of participants
6
Started
2026-01-27
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for prostate cancer
  • • Phase1/Phase2 - 6 participants
  • • ANDROMEDA is a first-in-human, Phase I/II, open-label, multicenter study of AZD9750 in participants with metastatic prostate cancer

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with prostate cancer
  • • Male only

Where?

  • • Cambridge - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

ANDROMEDA is a first-in-human, Phase I/II, open-label, multicenter study of AZD9750 in participants with metastatic prostate cancer. The trial evaluates safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of AZD9750 as monotherapy and in combination with saruparib.

More detail

This first-in-human (FiH), Phase I/II, open-label, multicenter study will evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9750 as monotherapy and in combination with saruparib in participants with metastatic prostate cancer. Additional combinations with other anticancer agents may be added via protocol amendment as separate modules. The study follows a modular design, allowing initial assessment of safety, tolerability, and preliminary efficacy across multiple treatment arms. Each Module has 2 parts: Part A (monotherapy dose escalation or combination dose finding) and Part B (monotherapy dose optimization and expansion or combination dose expansion). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention occur.

Prostate Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Male only

Biomarkers mentioned

PSA

What the study is looking for

  • ✓Participant must be ≥18 years or the legal age at the time of signing the agreement to take part form.
  • ✓confirmed by testing a sample diagnosis of adenocarcinoma of the prostate.
  • ✓Documented that has spread disease.
  • ✓Serum testosterone levels ≤ 50 ng/dL.
  • ✓Evidence of disease progression with one of the following:

Who cannot take part

  • ✗Participants with pathological finding consistent with any presence of small cell carcinoma, predominant...
  • ✗Brain metastases, or spinal cord compression.
  • ✗Any clinically significant heart disorders including QT prolongation, abnormal electrocardiogram (ECG).
  • ✗Active gastrointestinal disease or other condition that will interfere significantly with the absorption,...
  • ✗Participants with any known predisposition to bleeding (eg, active peptic ulceration, recent \[within 6 months\]...
See the full criteria
* 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.

Where Is This Study? (1 UK site)

Research Site

Cambridge CB2 2QQ, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-09