Clinical Trials in the UK / NCT07336446
Active, not recruiting
Phase 1/2
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
NCT07336446 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Prostate Cancer
Investigational drug(s) / intervention(s)
AZD9750AZD5305 →
AZD9750: AR-PROTAC
AZD5305: PARP1-selective inhibitor
Study summary
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.
Eligibility
* 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.
Primary outcome measure(s)
- Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only) — 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 — 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 — 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. — 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. — 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. — 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. — 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. — 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) — 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.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Duarte | California | |
| Research Site | Nashville | Tennessee | |
| Research Site | Melbourne | Australia | |
| Research Site | Kashiwa | Japan | |
| Research Site | Cambridge | United Kingdom |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07336446 on ClinicalTrials.gov ↗ ← All trials in the UK