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New treatment option for Prostate Cancer
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
ClinicalTrials.gov ID: NCT07336446
What this study is testing
What is AZD9750?
AZD9750 is an investigational medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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:
You likely can't join if
- Participants with pathological finding consistent with any presence of small cell carcinoma, predominant neuroendocrine carcinoma, or any predominant...
- 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...
- Active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism of AZD9750 and...
- Participants with any known predisposition to bleeding (eg, active peptic ulceration, recent [within 6 months] hemorrhagic stroke, proliferative...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- San Francisco, California, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Myrtle Beach, South Carolina, United States
- Nashville, Tennessee, United States
- Salt Lake City, Utah, United States
- Melbourne, Australia
- Calgary, Alberta, Canada
- Vancouver, British Columbia, Canada
- Chengdu, China
- Chūōku, Japan
- Kashiwa, Japan
- Amsterdam, Netherlands
- Rotterdam, Netherlands
- Barcelona, Spain
- Cambridge, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; San Francisco, California, United States; Tampa, Florida, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States; Myrtle Beach, South Carolina, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.