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 · Phase 1, Phase 2 · AstraZeneca · registry updated 2026-08-10
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
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:
- PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination.
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).