A Phase 1/2 interventional study of AZD9750 and AZD5305 in Prostate Cancer, sponsored by AstraZeneca. Active, not recruiting at 5 sites in 4 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by AstraZeneca · Phase 1/2, Interventional, and Treatment
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Among 91 studies in Prostatic Neoplasms by AstraZeneca — 15 open to participants now, 29 under way, 8 of them phase 3. Prostatic Neoplasms · AstraZeneca.
Among the 91 studies in Prostatic Neoplasms by AstraZeneca, this one is the 60th largest by enrollment of the 60 interventional ones that give a count, is one of 7 that started in 2026, is one of 11 in phase 1/2, reaches primary completion later than 6 of the 28 other live ones, and was the 85th registered.
7,047 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →15 of the 91 studies in Prostatic Neoplasms by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in United States, Austria, Brazil and 18 more countries
Ages 18+ · Men only
AstraZeneca · Sites in United States, Australia, Germany and 4 more countries
Ages 18–99 · Men only
AstraZeneca · Sites in United States, Australia, Korea, Republic of
Ages 18–100 · Men only
AstraZeneca · Sites in United States, Australia, Austria and 21 more countries
Ages 18+ · Men only
AstraZeneca · Sites in United States, Brazil, China and 7 more countries
Ages 18–130 · Men only
By country, each count listing its studies:
Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
91 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 27 · Phase 3 17 · Phase 4 4
First in 1994; this study’s year is marked. 7 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6 is below the median of 60 across 5,349 interventional studies indexed under Prostatic Neoplasms.
Median enrollment 110 across the 60 interventional studies, 310 across the 29 observational. Of the 58 that completed or were terminated, 11 (19%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
8 of the studies in Prostatic Neoplasms by AstraZeneca that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06120491Phase 3AstraZenecaSaruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents | 2027-09-30 |
| NCT06267729AstraZenecaStudy of AZD0754 in Participants With Metastatic Prostate Cancer | 2026-11-24 |
| NCT06402331Fusion Pharmaceuticals Inc.FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) | 2026-12-23 |
| NCT06380738AstraZenecaReal-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed) | 2027-02-14 |
| NCT07560215AstraZenecaPROMET-BR - Molecular Profiling of Metastatic Prostate Cancer: a Brazilian Cohort | 2027-03-31 |
Add all 8 to your calendar (.ics) → With an account.
Among the 91 studies in Prostatic Neoplasms by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
This first-in-human (FiH), Phase I/II, open-label, multicenter study will evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9750 as monotherapy and in combination with saruparib in participants with metastatic prostate cancer. Additional combinations with other anticancer agents may be added via protocol amendment as separate modules. The study follows a modular design, allowing initial assessment of safety, tolerability, and preliminary efficacy across multiple treatment arms. Each Module has 2 parts: Part A (monotherapy dose escalation or combination dose finding) and Part B (monotherapy dose optimization and expansion or combination dose expansion). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention occur.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participant must be ≥18 years or the legal age at the time of signing the form.
Evidence of disease progression with one of the following:
Part A (Module 1)
Part B (Module 1)
Participants with pathological finding consistent with any presence of small cell carcinoma, predominant neuroendocrine carcinoma, or any predominant histology other than prostate adenocarcinoma.
Other protocol-defined inclusion/exclusion criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AZD9750 Monotherapy (Dose Escalation) - No randomization
Drug: AZD9750
AZD9750 Monotherapy (Backfills) - No randomization
Drug: AZD9750
AZD9750 Monotherapy (Dose Optimization) - Randomization
Drug: AZD9750
AZD9750 Monotherapy (Dose Expansion) - No randomization
Drug: AZD9750
AZD9750 Monotherapy (Dose Expansion) - No randomization
Drug: AZD9750
AZD9750 + Saruparib (Combination Dose Finding) - No Randomization
Drug: AZD9750 · Drug: AZD5305
AZD9750 + Saruparib (Combination Dose Expansion) - No Randomization
Drug: AZD9750 · Drug: AZD5305
AR-PROTAC
PARP1-selective inhibitor
Also known as: Saruparib
Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only)
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.
Time frame: From first dose of study intervention to 28 days post first dose
Number of participants with Adverse Events and Serious Adverse Events
The number of participants with adverse events and with serious adverse events will be assessed.
Time frame: From first dose of study intervention up to 37 days after the last dose of study treatment
Number of participants with Adverse Events leading to discontinuation of study intervention
The number of participants with clinically significant changes from baseline in vital signs will be assessed.
Time frame: From first dose of study intervention up to 37 days after the last dose of study treatment
Clinically significant changes from baseline in vital signs.
The number of participants with clinically significant changes from baseline in vital signs will be assessed.
Time frame: From first study dose up to 37 days after the last dose of study treatment
Clinically significant changes from baseline in physical examination.
The number of participants with clinically significant changes from baseline in physical examination will be assessed.
Time frame: From first dose of study intervention up to 37 days after the last dose of study treatment
Clinically significant changes from baseline in ECOG PS.
The number of participants with clinically significant changes from baseline in ECOG PS will be assessed.
Time frame: From first dose of study intervention up to 37 days after the last dose of study treatment
Clinically significant changes from baseline in ECGs.
The number of participants with clinically significant changes from baseline in ECGs will be assessed.
Time frame: From first dose of study intervention up to 37 days after the last dose of study treatment
Clinically significant changes from baseline in laboratory parameters.
The number of participants with clinically significant changes from baseline in laboratory parameters will be assessed.
Time frame: From first dose of study intervention up to 37 days after the last dose of study treatment
Proportion of participants achieving a ≥50% decrease in PSA from baseline (PSA50) (Part B only)
To evaluate the preliminary antitumour efficacy of AZD9750 as monotherapy and in combination with other anticancer agents in participants with mCRPC.
Time frame: From first dose of study intervention up to 14 days after the last dose of study treatment
Proportion of participants achieving a ≥ 50% decrease in PSA from baseline (PSA50) (Part A only)
To evaluate the preliminary antitumour efficacy of AZD9750 as monotherapy and in combination with other anticancer agents.
Time frame: From first dose of study intervention up to initiation of subsequent anticancer therapy (or radiotherapy on target lesions), PSA progression or 14 days after the last dose of study treatment
Proportion of participants achieving a ≥ 90% decrease in PSA from baseline (PSA90)
To evaluate the preliminary antitumour efficacy of AZD9750 as monotherapy and in combination with other anticancer agents.
Time frame: From first dose of study intervention up to initiation of subsequent anticancer therapy (or radiotherapy on target lesions), PSA progression or 14 days after the last dose of study treatment
Objective response rate (ORR)
To evaluate the preliminary antitumour efficacy of AZD9750 as monotherapy and in combination with other anticancer agents. ORR will be assessed according to RECIST v1.1 and PCWG3 criteria (bone) and is defined as the percentage of participants who have a confirmed best overall response of CR or PR or NED (in case the subject has neither TLs nor NTLs at baseline) that occurs prior to the initiation of subsequent anticancer treatment (or radiotherapy on target lesions) and prior to progression.
Time frame: From randomisation or first dose of study intervention to initiation of subsequent anticancer treatment (or radiotherapy on target lesions) or progression, assessed up to 60 months
Duration of response (DoR)
To evaluate the preliminary antitumour efficacy of AZD9750 as monotherapy and in combination with other anticancer agents. DoR is defined as the time from the date of first documented objective response (which is subsequently confirmed) until the date of first documented radiological disease progression or death (by any cause in the absence of disease progression).
Time frame: From randomisation or first dose of study intervention to the date of first documented radiological disease progression, assessed up to 60 months
Time to response (TTR)
To evaluate the preliminary antitumour efficacy of AZD9750 as monotherapy and in combination with other anticancer agents. TTR is defined as the time from randomisation/first dose until the first documentation of a subsequently confirmed objective response prior to progression and prior to starting any subsequent cancer therapy (or radiotherapy on target lesions).
Time frame: From randomisation or first dose of study intervention to initiation of subsequent anticancer treatment (or radiotherapy on target lesions) or progression, assessed up to 60 months
Radiographic progression-free survival (rPFS)
To evaluate the preliminary antitumour efficacy of AZD9750 as monotherapy and in combination with other anticancer agents. rPFS is defined as the time from the date of randomisation or first dose until the date of radiographic progression, as assessed per RECIST v1.1 (soft tissue) and/or PCWG3 criteria (bone) and derived from the raw tumour data or death (by any cause in the absence of progression).
Time frame: From randomisation or first dose of study intervention to progression, assessed up to 60 months
Best percentage change in target lesion size from baseline
To evaluate the preliminary antitumour efficacy of AZD9750 as monotherapy and in combination with other anticancer agents. The best change in tumour size from baseline (i.e. depth of response) is the largest decrease from baseline or the smallest increase from baseline in the absence of a reduction and includes all assessments: * up to and including the first visit at which the overall visit response is PD, * prior to death in the absence of progression, * prior to the start of subsequent anti-cancer therapy (or radiotherapy on target lesions) * or up to and including the last evaluable RECIST assessment if the subject has not died, progressed or started subsequent anti-cancer therapy (or radiotherapy on target lesions).
Time frame: From screening (Day -28) to initiation of subsequent anticancer treatment (or radiotherapy on target lesions) or progression, assessed up to 60 months
Time to PSA response (TTPSA50, TTPSA90)
To evaluate the preliminary antitumour efficacy of AZD9750 as monotherapy and in combination with other anticancer agents. TTPSA is defined as the time from randomisation or first dose date until the date of the first documented PSA50 or PSA90 response (which is subsequently confirmed), respectively.
Time frame: From first dose of study intervention up to initiation of subsequent anticancer therapy (or radiotherapy on target lesions), PSA progression or 14 days after the last dose of study treatment
Cmax of AZD9750
To characterize the PK of AZD9750 as monotherapy and in combination with other anticancer agents.
Time frame: From date of first dose of study intervention up to 115 days after first dose
tmax of AZD9750
To characterize the PK of AZD9750 as monotherapy and in combination with other anticancer agents.
Time frame: From date of first dose of study intervention up to 115 days after first dose
AUC of AZD9750
To characterize the PK of AZD9750 as monotherapy and in combination with other anticancer agents.
Time frame: From date of first dose of study intervention up to 115 days after first dose
Cmax of saruparib (Module 2 only)
To characterize the PK of saruparib in combination with AZD9750.
Time frame: From date of first dose of study intervention up to 57 days after first dose
Tmax of saruarib (Module 2 only)
To characterize the PK of saruparib in combination with AZD9750.
Time frame: From date of first dose of study intervention up to 57 days after first dose
AUC of saruparib (Module 2 only)
To characterize the PK of saruparib in combination with AZD9750.
Time frame: From date of first dose of study intervention up to 57 days after first dose
Started Jan 2026 (actual). Primary completion is estimated for Nov 2026, 9 months after the start.
Of 97 industry-sponsored phase 1/2 interventional studies under Prostatic Neoplasms, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 35. This study's planned 9 months is below that.
Counting every sponsor, half of 211 studies reached it within 61 months; a quarter within 30 and three quarters within 85.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 2, 2026: primary completion Jan 2029 → Nov 2026 and completion Jan 2029 → Nov 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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