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Testing AZD9750 alone or with other cancer drugs for metastatic prostate cancer

A Phase I/II, Modular, Open-Label, Multi-Centre Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD9750 as Monotherapy and in Combination With Other Anticancer Agents in Participants With Metastatic Prostate Cancer (ANDROMEDA)

Phase1; Phase2 Interventional AstraZeneca · NCT07336446

This trial tests whether AZD9750, given alone or with other anticancer drugs such as saruparib, is safe and helps people with metastatic prostate cancer.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexMale
SponsorAstraZeneca Industry-sponsored
Drugs / interventionschemotherapy
Locations18 sites (Duarte, California and 17 other locations)
Trial IDNCT07336446 on ClinicalTrials.gov

What this trial studies

ANDROMEDA is a first-in-human, open-label Phase 1/2 modular study of AZD9750 in adults with metastatic prostate adenocarcinoma. The study includes dose-escalation (Part A) and dose-expansion/optimization (Part B) modules for monotherapy and combination regimens, initially including saruparib and with the option to add other agents. Key outcomes include safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary signs of antitumor activity, with treatment continued until progression or unacceptable toxicity. The trial is multicenter and will enroll participants who meet defined progression and organ-function criteria and have ECOG 0–1.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed metastatic prostate adenocarcinoma who have shown disease progression, have castrate-level testosterone, ECOG performance status 0–1, and adequate organ function.

Not a fit: Patients unlikely to benefit include those with poor performance status (ECOG >1), uncontrolled medical conditions, non-adenocarcinoma prostate cancers, or those who cannot meet the study's safety and laboratory criteria.

Why it matters

Potential benefit: If successful, AZD9750 could provide a new treatment option that delays disease progression or improves control of metastatic prostate cancer, alone or when combined with other drugs.

How similar studies have performed: This is the first-in-human trial of AZD9750, while related approaches (PROTACs and PARP inhibitors in combinations) have shown early promise in small studies but remain investigational.

Eligibility criteria

Show full inclusion / exclusion criteria 
* 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:

    1. PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination.
    2. Radiographic progression of soft tissue disease by RECIST v1.1 with or without PSA progression.
    3. 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 this trial is running

Duarte, California and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prostate CancerMetastasic Prostate CancerAndrogen ReceptorProteolysis-targeting chimeras
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.