No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for men with metastatic prostate cancer to test a new treatment called AZD9750. Participants will either receive AZD9750 alone or with another drug and will be closely monitored for safety and how well it works.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with prostate cancer.
I have metastatic prostate cancer.
My testosterone levels are 50 ng/dL or lower.
I have seen signs that my cancer is getting worse.
My overall health score is 0 or 1.
I have enough bone marrow and organ function.
You may not be able to join if
I have small cell carcinoma or any other type of cancer apart from prostate adenocarcinoma.
I have brain tumors or spinal cord compression.
I have serious heart problems.
I have uncontrolled high blood pressure.
I have active digestive diseases that affect how drugs work.
I have a history of bleeding problems.
I have had treatment with an AR-PROTAC before.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility 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.
* Evid…
* 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.
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