Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-05-01
300
Participants Needed
18
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years or older at the time of signing consent.
- Confirmed diagnosis of prostate adenocarcinoma by histology or cytology.
- Documented metastatic prostate cancer.
- Serum testosterone levels of 50 ng/dL or lower.
- Evidence of disease progression shown by rising PSA levels, radiographic soft tissue progression, or new bone lesions.
- ECOG performance status score of 0 or 1.
- Adequate bone marrow and organ function.
- For Part A1 dose escalation: At least 1 prior androgen receptor pathway inhibitor (ARPI) and, if applicable, at least 1 prior taxane-based chemotherapy.
- For Part A2 backfill: 1 to 2 prior ARPIs and, if applicable, 1 to 2 prior taxane-based chemotherapies.
- For Part B dose optimization/expansion: 1 to 2 prior ARPIs and, if applicable, 1 to 2 prior taxane-based chemotherapies.
- For Part B3 dose expansion (no taxane cohort): 1 to 2 prior ARPIs for metastatic prostate cancer and no prior taxane treatment.
You will not qualify if you...
- Presence of small cell carcinoma, neuroendocrine carcinoma, or other predominant histology aside from prostate adenocarcinoma.
- Brain metastases or spinal cord compression.
- Significant cardiac disorders including QT prolongation or abnormal ECG.
- Significant cardiovascular diseases such as symptomatic heart failure, uncontrolled hypertension, acute coronary syndrome, cardiomyopathy, valvular heart disease, atrial fibrillation, or stroke.
- Active gastrointestinal disease or conditions interfering with drug absorption or metabolism.
- Known bleeding risks such as active peptic ulceration, recent hemorrhagic stroke, or proliferative diabetic retinopathy.
- Prior treatment with an AR-PROTAC.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Research Site
Duarte, California, United States, 91010
Actively Recruiting
2
Research Site
San Francisco, California, United States, 94143
Not Yet Recruiting
3
Research Site
Tampa, Florida, United States, 33612
Not Yet Recruiting
4
Research Site
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
5
Research Site
St Louis, Missouri, United States, 63108
Not Yet Recruiting
6
Research Site
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
7
Research Site
Nashville, Tennessee, United States, 37203
Actively Recruiting
8
Research Site
Salt Lake City, Utah, United States, 84112
Not Yet Recruiting
9
Research Site
Melbourne, Australia, 3000
Actively Recruiting
10
Research Site
Calgary, Alberta, Canada, T2N 5G2
Not Yet Recruiting
11
Research Site
Vancouver, British Columbia, Canada, V5Z 1H7
Not Yet Recruiting
12
Research Site
Chengdu, China, 610041
Not Yet Recruiting
13
Research Site
Chūōku, Japan, 104-0045
Not Yet Recruiting
14
Research Site
Kashiwa, Japan, 227-8577
Actively Recruiting
15
Research Site
Amsterdam, Netherlands, 1066CX
Not Yet Recruiting
16
Research Site
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
17
Research Site
Barcelona, Spain, 8035
Not Yet Recruiting
18
Research Site
Cambridge, United Kingdom, CB2 2QQ
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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