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 · NCT07336446 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca
View the official record on ClinicalTrials.gov →Interventions studied
AZD5305AZD9750
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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:
- PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination.
- Radiographic progression of soft tissue disease by RECIST v1.1 with or without PSA progression.
- 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.
- ther protocol-defined inclusion/exclusion criteria apply.
Where it is running
18 locations listed across 7 US states.
- Research Site - Duarte, California, United States
- Research Site - San Francisco, California, United States
- Research Site - Tampa, Florida, United States
- Research Site - Boston, Massachusetts, United States
- Research Site - St Louis, Missouri, United States
- Research Site - Myrtle Beach, South Carolina, United States
- Research Site - Nashville, Tennessee, United States
- Research Site - Salt Lake City, Utah, United States
- Research Site - Amsterdam, Netherlands
- Research Site - Barcelona, Spain
- Research Site - Cambridge, United Kingdom
- Research Site - Chengdu, China
- Research Site - Chūōku, Japan
- Research Site - Kashiwa, Japan
- Research Site - Melbourne, Australia
- Research Site - Rotterdam, Netherlands
- Research Site - Calgary, Alberta, Canada
- Research Site - Vancouver, British Columbia, Canada