Prostate CancerPhase 1/2ANDROMEDANCT07336446
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
A Phase 1/2 study testing AZD9750 and AZD5305 in people with Prostate Cancer, run by AstraZeneca at 5 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- AZD9750 and AZD5305
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 27 Jan 2026to 5 Nov 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
Research Site
Duarte, California, 91010
Research Site
Nashville, Tennessee, 37203
About this study
Official title: 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)
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- AZD9750, AZD5305
- Keywords
- Metastasic Prostate Cancer, Prostate Cancer, Androgen Receptor, Proteolysis-targeting chimeras (PROTACs)
- Medical subject headings
- Prostatic Neoplasms, Bulbo-Spinal Atrophy, X-Linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9750Drug
AR-PROTAC
AZD5305Drug
Also called Saruparib
PARP1-selective inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Module 1 / Part A1 | Experimental | AZD9750 Monotherapy (Dose Escalation) - No randomization Receives: Drug: AZD9750 |
| Module 1 / Part A2 | Experimental | AZD9750 Monotherapy (Backfills) - No randomization Receives: Drug: AZD9750 |
| Module 1 / Part B1 | Experimental | AZD9750 Monotherapy (Dose Optimization) - Randomization Receives: Drug: AZD9750 |
| Module 1 Part B2 | Experimental | AZD9750 Monotherapy (Dose Expansion) - No randomization Receives: Drug: AZD9750 |
| Module 1 / Part B3 | Experimental | AZD9750 Monotherapy (Dose Expansion) - No randomization Receives: Drug: AZD9750 |
| Module 2 / Part A | Experimental | AZD9750 + Saruparib (Combination Dose Finding) - No Randomization Receives: Drug: AZD9750; Drug: AZD5305 |
| Module 2/ Part B | Experimental | AZD9750 + Saruparib (Combination Dose Expansion) - No Randomization Receives: Drug: AZD9750; Drug: AZD5305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From first dose of study intervention up to 14 days after the last dose of study treatment
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From date of first dose of study intervention up to 57 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start27 Jan 2026
- Primary completion5 Nov 2026 (estimated)
- Study completion5 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- First-in-human, modular, open-label, Phase I/II study with sequential assignment across modules and parts: Part A (monotherapy dose escalation or combination dose finding) and Part B (dose optimization and expansion), evaluating AZD9750 as monotherapy and in combination with saruparib in participants with metastatic prostate cancer.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336446
- Sponsor's protocol ID
- D7270C00001
- Acronym
- ANDROMEDA
- Status last verified
- Sep 2026
- First submitted
- 19 Dec 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07336446
- Acronym / sponsor ID
- ANDROMEDA / D7270C00001
- Conditions
- Prostate Cancer
- Keywords
- Metastasic Prostate Cancer, Prostate Cancer, Androgen Receptor, Proteolysis-targeting chimeras (PROTACs)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 5 Nov 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- First-in-human, modular, open-label, Phase I/II study with sequential assignment across modules and parts: Part A (monotherapy dose escalation or combination dose finding) and Part B (dose optimization and expansion), evaluating AZD9750 as monotherapy and in combination with saruparib in participants with metastatic prostate cancer.
| Arm | Type | Receives |
|---|---|---|
| Module 1 / Part A1 | Experimental | Drug: AZD9750AZD9750 Monotherapy (Dose Escalation) - No randomization |
| Module 1 / Part A2 | Experimental | Drug: AZD9750AZD9750 Monotherapy (Backfills) - No randomization |
| Module 1 / Part B1 | Experimental | Drug: AZD9750AZD9750 Monotherapy (Dose Optimization) - Randomization |
| Module 1 Part B2 | Experimental | Drug: AZD9750AZD9750 Monotherapy (Dose Expansion) - No randomization |
| Module 1 / Part B3 | Experimental | Drug: AZD9750AZD9750 Monotherapy (Dose Expansion) - No randomization |
| Module 2 / Part A | Experimental | Drug: AZD9750, Drug: AZD5305AZD9750 + Saruparib (Combination Dose Finding) - No Randomization |
| Module 2/ Part B | Experimental | Drug: AZD9750, Drug: AZD5305AZD9750 + Saruparib (Combination Dose Expansion) - No Randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
Key exclusion criteria (8 listed)
- Other protocol-defined inclusion/exclusion criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD9750AR-PROTAC | Drug | Module 1 / Part A1, Module 1 / Part A2, Module 1 / Part B1, Module 1 / Part B3, Module 1 Part B2, Module 2 / Part A, Module 2/ Part B |
| AZD5305Also: SaruparibPARP1-selective inhibitor | Drug | Module 2 / Part A, Module 2/ Part B |
Primary outcome
Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
14 secondary outcomes
Proportion of participants achieving a ≥ 50% decrease in PSA from baseline (PSA50) (Part A only)
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)
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)
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)
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)
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)
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
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)
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
Time frame: From date of first dose of study intervention up to 115 days after first dose
tmax of AZD9750
Time frame: From date of first dose of study intervention up to 115 days after first dose
AUC of AZD9750
Time frame: From date of first dose of study intervention up to 115 days after first dose
Cmax of saruparib (Module 2 only)
Time frame: From date of first dose of study intervention up to 57 days after first dose
Tmax of saruarib (Module 2 only)
Time frame: From date of first dose of study intervention up to 57 days after first dose
AUC of saruparib (Module 2 only)
Time frame: From date of first dose of study intervention up to 57 days after first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD9750 and AZD5305 in people with Prostate Cancer, run by AstraZeneca at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia, Japan, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only) (time frame: From first dose of study intervention to 28 days post first dose). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.