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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (1 UK site)
Research Site
Cambridge CB2 2QQ, United Kingdom
