NCT07336446 · AstraZeneca
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
(ANDROMEDA)
What this study is about
ANDROMEDA is a first-in-human, Phase I/II, where both patients and doctors know the treatment given, conducted at multiple hospitals study of AZD9750 in participants with metastatic prostate cancer.
View original scientific description
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.
Interventions
DRUG
AZD9750
AR-PROTAC
DRUG
AZD5305
PARP1-selective inhibitor
Primary outcome measures
Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only)
Time frame: From first dose of study intervention to 28 days post first dose
To evaluate the safety and tolerability and determine the MTD and/or the RDE(s)/RP2D of AZD9750 as a monotherapy and in combination with other anticancer agents in participants with mCRPC. A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.
Number of participants with Adverse Events and Serious Adverse Events
Time frame: From first dose of study intervention up to 37 days after the last dose of study treatment
The number of participants with adverse events and with serious adverse events will be assessed.
Number of participants with Adverse Events leading to discontinuation of study intervention
Time frame: From first dose of study intervention up to 37 days after the last dose of study treatment
The number of participants with clinically significant changes from baseline in vital signs will be assessed.
Clinically significant changes from baseline in vital signs.
Time frame: From first study dose up to 37 days after the last dose of study treatment
The number of participants with clinically significant changes from baseline in vital signs will be assessed.
Clinically significant changes from baseline in physical examination.
Time frame: From first dose of study intervention up to 37 days after the last dose of study treatment
The number of participants with clinically significant changes from baseline in physical examination will be assessed.
Clinically significant changes from baseline in ECOG PS.
Time frame: From first dose of study intervention up to 37 days after the last dose of study treatment
The number of participants with clinically significant changes from baseline in ECOG PS will be assessed.
Clinically significant changes from baseline in ECGs.
Time frame: From first dose of study intervention up to 37 days after the last dose of study treatment
The number of participants with clinically significant changes from baseline in ECGs will be assessed.
Clinically significant changes from baseline in laboratory parameters.
Time frame: From first dose of study intervention up to 37 days after the last dose of study treatment
The number of participants with clinically significant changes from baseline in laboratory parameters will be assessed.
Proportion of participants achieving a ≥50% decrease in PSA from baseline (PSA50) (Part B only)
Time frame: From first dose of study intervention up to 14 days after the last dose of study treatment
To evaluate the preliminary antitumour efficacy of AZD9750 as monotherapy and in combination with other anticancer agents in participants with mCRPC.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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. Other protocol-defined inclusion/exclusion criteria apply.
Where
- Duarte, California
- San Francisco, California
- Tampa, Florida
- Boston, Massachusetts
- St Louis, Missouri
- Myrtle Beach, South Carolina
- Nashville, Tennessee
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 10, 2026 · Source of record for eligibility and locations