Metastatic Castration-Resistant Prostate CancerPhase 1NCT06879041
A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study testing AZD2287, AZD2275 and AZD2284 in people with Metastatic Castration-Resistant Prostate Cancer, run by AstraZeneca at 16 sites in 3 countries.
Trial summary
The main purpose of the study is to assess the safety and tolerability of AZD2284, AZD2287, and AZD2275. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-Resistant Prostate Cancer
- What is being tested?
- AZD2287, AZD2275 and AZD2284
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 10 Mar 2025to 16 Apr 2029
- Phase
- Phase 1
- 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
- eria:
- • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- • Histologically confirmed diagnosis of adenocarcinoma of the prostate without strong clinical suspicion of majority neuroendocrine differentiation.
- • Must have had prior bilateral orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
- • At least one metastatic lesion present on baseline Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or bone scan obtained ≤ 28 days prior to the first dose of Investigational Medicinal Product (IMP). Participants may have non-measurable lesions including bone only metastases.
- • Adequate organ function
Show all 22Show fewer
- • Part A only: Metastatic prostate cancer considered to be stable or progressing metastatic castration resistant prostate cancer (mCRPC).
- • Part B only: Progressing mCRPC defined as meeting at least one of following documented criteria -
- a)Serum/plasma PSA progression
- b)Soft-tissue progression
- c)Progression of bone disease
- • Part B Dose Escalation: Previously treated with at least 2 prior lines of systemic anti-cancer therapy for mCRPC. Prior lines must include:
- a)At least 1 androgen receptor pathway inhibitor (ARPI)
- b)A poly (adp-ribose) polymerase (PARP) inhibitor for participants with known BRCA mutation
- c)A checkpoint inhibitor for participants with known microsatellite instability-high (MSI-H), deficient mismatch pair (dMMR), or tumor mutational burden (TMB) ≥ 10 mut/Mb
- • Part B Dose Expansion: Previously treated with at least 1 prior line of systemic anti-cancer therapy for mCRPC. Prior lines must include:
- (a)At least 1 ARPI
- (b)A PARP inhibitor for participants with known BRCA mutation per local practice, unless ineligible per Investigator decision.
- (c)A checkpoint inhibitor for participants with known MSI-H, dMMR, or TMB ≥ 10 mut/Mb.
- (d)No previous cytotoxic chemotherapy for CRPC. Taxanes for metastatic hormone sensitive prostate cancer (mHSPC) is acceptable if the last cycle Day 1 was > 12 months before first study treatment.
- (e)Previous treatment with prostate specific membrane antigen radioligand therapy (PSMA-RLT) or Radium-223 is allowed but not required. Participants who have had prior radiation therapy, including therapeutic radiopharmaceuticals, external bean radiation therapy (EBRT), and/or brachytherapy are eligible, subject to satisfying all other inclusion/exclusion criteria. Therapeutic radiopharmaceuticals will be considered a prior line of systemic therapy.
- Main
Who cannot join
- • Treatment with any radiopharmaceutical within 6 weeks of the first dose of Investigational Medicinal Product (IMP).
- • Radiation therapy (RT) or external beam radiation therapy (EBRT) within 28 days prior to the first dose and all RT-related events have not recovered to Grade ≤ 1.
- • Administration of any systemic cytotoxic or investigational therapy ≤ 28 days of the first dose of IMP or 5 half-lives, whichever is shorter.
- • All prior treatment-related adverse events must have resolved to Grade ≤ 1.
- • Concurrent severe and/or uncontrolled illness not related to cancer and/or social situation that would limit compliance with study requirements.
- • Known or suspected allergies or contraindications to any of the investigational drugs or any component of the investigational drug formulation.
Show all 9Show fewer
- • Clinically relevant proteinuria
- • Diffuse and intense osseous radiotracer uptake on bone scintigraphy or PSMA imaging characteristic of a superscan.
- • Chronic corticosteroid use greater than 10 mg prednisone equivalent daily.
Trial locations and contacts
16 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
16 sites in 3 countries
United States12 sites, 12 recruiting
- Recruiting
Research Site
Boston, Massachusetts, 02215
- Recruiting
Research Site
Chicago, Illinois, 60637
- Not yet recruiting
Research Site
Cleveland, Ohio, 44195
- Not yet recruiting
Research Site
Metairie, Louisiana, 70006
- Recruiting
Research Site
Miami, Florida, 33165
- Not yet recruiting
Research Site
New York, New York, 10032
- Recruiting
Research Site
Omaha, Nebraska, 68130
- Not yet recruiting
Research Site
Palo Alto, California, 94304
- Not yet recruiting
Research Site
Portland, Oregon, 97239
- Not yet recruiting
Research Site
Rochester, Minnesota, 55902
- Not yet recruiting
Research Site
San Diego, California, 92103
- Recruiting
Research Site
Tampa, Florida, 33612
South Africa3 sites, 2 recruiting
- Not yet recruiting
Research Site
CapeTown, 7925
- Withdrawn
Research Site
Durban, 4013
- Recruiting
Research Site
Pretoria, 181
About this study
Official title: A Phase I, First-in-human, Dose Escalation Study Of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
The main purpose of the study is to assess the safety and tolerability of AZD2284, AZD2287, and AZD2275.
Read the detailed description
This is a first-in-human, Phase I, non-randomized, open-label clinical trial designed to evaluate AZD2284, AZD2287, and AZD2275.
This trial will consist of 2 Parts:
Part A (Imaging):
- Part A (Cold Antibody Exploration): aims to determine the optimal dosing regimen, with or without unconjugated antibody (AZD2275) pre-administration to improve the biodistribution of AZD2287.
Part B (Therapeutic):
- Part B (Actinium-225 Dose Escalation): aims to assess the safety, tolerability, and efficacy of escalating doses of AZD2284 informed by the optimal dosing regimen identified in Part A.
- Part B Expansion Cohorts 1 and 2: aims to explore efficacy of AZD2284.
- Being tested
- AZD2287, AZD2275, AZD2284
- Keywords
- Dose Escalation Study, Metastatic Prostate Cancer, Radiopharmaceutical, Radiotheranostics, Castration-Resistant Prostate Cancer, Radiotherapy, Six Transmembrane Epithelial Antigen of the Prostate 2 (STEAP2), Actinium, Radioconjugate, Radioligand
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2287Drug
Participants will receive AZD2287
AZD2275Drug
Participants will receive AZD2275
AZD2284Drug
Participants will receive AZD2284
| Study group | Role | What they receive |
|---|---|---|
| Part A: Cohort A1: AZD2287 (Hot only) | Experimental | Participants will receive AZD2287. If eligible for treatment, will receive dose level (DL)1 of AZD2284. Receives: Drug: AZD2287; Drug: AZD2284 |
| Part A: Cohort A2: AZD2275 + AZD2287 (Cold +Hot) | Experimental | Participants will receive DL1 of AZD2275 followed by AZD2287. If eligible for treatment, will receive DL1 of AZD2284. Receives: Drug: AZD2287; Drug: AZD2275; Drug: AZD2284 |
| Part A: Cohort A3: AZD2275 + AZD2287 (Cold +Hot) | Experimental | Participants will receive DL2 of AZD2275 followed by AZD2287. If eligible for treatment, will receive DL1 of AZD2284. Receives: Drug: AZD2287; Drug: AZD2275; Drug: AZD2284 |
| Part B (Actinium-225 Dose Escalation): DL1: AZD2284 | Experimental | Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive DL1 of AZD2284. Receives: Drug: AZD2287; Drug: AZD2275; Drug: AZD2284 |
| Part B (Actinium-225 Dose Escalation): DL2: AZD2284 | Experimental | Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive DL2 of AZD2284. Receives: Drug: AZD2287; Drug: AZD2275; Drug: AZD2284 |
| Part B (Actinium-225 Dose Escalation): DL3: AZD2284 | Experimental | Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive DL3 of AZD2284. Receives: Drug: AZD2287; Drug: AZD2275; Drug: AZD2284 |
| Part B (Actinium-225 Dose Escalation): DL4: AZD2284 | Experimental | Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive DL4 of AZD2284. Receives: Drug: AZD2287; Drug: AZD2275; Drug: AZD2284 |
| Part B: Cohort E1 | Experimental | Participants will receive dose of AZD2284 determined by the earlier results. Expansion cohort may be opened to further characterize the safety and efficacy of the dose level. Receives: Drug: AZD2287; Drug: AZD2275; Drug: AZD2284 |
| Part B: Cohort E2 | Experimental | Participants will receive dose of AZD2284 determined by the earlier results. Expansion cohort may be opened to further characterize the safety and efficacy of the dose level. Receives: Drug: AZD2287; Drug: AZD2275; Drug: AZD2284 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse event (AEs)
Measured: Part A: Up to Day 28; Part B: Up to 5 years
Number of participants with Dose Limiting Toxicities (DLTs)
Measured: Part B: Up to 84 days of receiving AZD2284
Estimates of residence time
Measured: Part A: Up to 8 days after a dose of AZD2287
Absorbed radiation doses for AZD2287 and AZD2284
Measured: Part A: Up to 8 days after a dose of AZD2287; Part B: Up to 7 days after a dose of AZD2287
Compare organ uptake of AZD2287 with and without pre-dose administration of AZD2275
Measured: Part A: Up to 8 days after a dose of AZD2287; Part B: Up to 7 days after a dose of AZD2287
Tumor uptake of AZD2287 in selected regions of interest on SPECT/CT and/or planar images
Measured: Part A: Up to 8 days after a dose of AZD2287; Part B: Up to 7 days after a dose of AZD2287
Secondary outcomes (13)
Overall Response Rate (ORR)
Measured: Up to 12 months after the last dose of AZD2284
Proportion of participants with Prostate-Specific Antigen (PSA) 50
Measured: Up to 12 months after the last dose of AZD2284
Proportion of participants with PSA90
Measured: Up to 12 months after the last dose of AZD2284
Time to PSA50 response
Measured: Up to 12 months after the last dose of AZD2284
Duration of Response (DoR)
Measured: Up to 12 months after the last dose of AZD2284
Radiographic Progression Free Survival (rPFS)
Measured: Up to 12 months after the last dose of AZD2284
Overall Survival (OS)
Measured: Part A: Up to Day 28; Part B: Up to 5 years
Pharmacokinetic Clearance
Measured: Part A: Up to Day 28; Part B: Up to 84 days
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Measured: Part A: Up to Day 28; Part B: Up to 84 days
Maximum observed drug concentration (Cmax)
Measured: Part A: Up to Day 28; Part B: Up to 84 days
Half-life (t1/2)
Measured: Part A: Up to Day 28; Part B: Up to 84 days
Changes in plasma concentrations of AZD2287 and AZD2284 following AZD2275 pre-administration compared to AZD2287 and AZD2284 alone
Measured: Part A: Up to Day 28; Part B: Up to 84 days
Number of participants with positive antidrug antibodies (ADAs)
Measured: Part A: Up to Day 28; Part B: Approximately 28 days after End of Treatment (EOT) visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start10 Mar 2025
- Primary completion16 Apr 2029 (estimated)
- Study completion16 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-Resistant 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879041
- Sponsor's protocol ID
- D7580C00001
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes",indicatesthat AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, First-in-human, Dose Escalation Study Of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT06879041
- Acronym / sponsor ID
- D7580C00001
- Keywords
- Dose Escalation Study, Metastatic Prostate Cancer, Radiopharmaceutical, Radiotheranostics, Castration-Resistant Prostate Cancer, Radiotherapy, Six Transmembrane Epithelial Antigen of the Prostate 2 (STEAP2), Actinium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 16 Apr 2029 (estimated)
- Study completion
- 16 Apr 2029 (estimated)
- First posted
- 17 Mar 2025 (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.
The main purpose of the study is to assess the safety and tolerability of AZD2284, AZD2287, and AZD2275.
Detailed description
This is a first-in-human, Phase I, non-randomized, open-label clinical trial designed to evaluate AZD2284, AZD2287, and AZD2275.
This trial will consist of 2 Parts:
Part A (Imaging):
- Part A (Cold Antibody Exploration): aims to determine the optimal dosing regimen, with or without unconjugated antibody (AZD2275) pre-administration to improve the biodistribution of AZD2287.
Part B (Therapeutic):
- Part B (Actinium-225 Dose Escalation): aims to assess the safety, tolerability, and efficacy of escalating doses of AZD2284 informed by the optimal dosing regimen identified in Part A.
- Part B Expansion Cohorts 1 and 2: aims to explore efficacy of AZD2284.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part A: Cohort A1: AZD2287 (Hot only) | Experimental | Drug: AZD2287, Drug: AZD2284Participants will receive AZD2287. If eligible for treatment, will receive dose level (DL)1 of AZD2284. |
| Part A: Cohort A2: AZD2275 + AZD2287 (Cold +Hot) | Experimental | Drug: AZD2287, Drug: AZD2275, Drug: AZD2284Participants will receive DL1 of AZD2275 followed by AZD2287. If eligible for treatment, will receive DL1 of AZD2284. |
| Part A: Cohort A3: AZD2275 + AZD2287 (Cold +Hot) | Experimental | Drug: AZD2287, Drug: AZD2275, Drug: AZD2284Participants will receive DL2 of AZD2275 followed by AZD2287. If eligible for treatment, will receive DL1 of AZD2284. |
| Part B (Actinium-225 Dose Escalation): DL1: AZD2284 | Experimental | Drug: AZD2287, Drug: AZD2275, Drug: AZD2284Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive DL1 of AZD2284. |
| Part B (Actinium-225 Dose Escalation): DL2: AZD2284 | Experimental | Drug: AZD2287, Drug: AZD2275, Drug: AZD2284Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive DL2 of AZD2284. |
| Part B (Actinium-225 Dose Escalation): DL3: AZD2284 | Experimental | Drug: AZD2287, Drug: AZD2275, Drug: AZD2284Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive DL3 of AZD2284. |
| Part B (Actinium-225 Dose Escalation): DL4: AZD2284 | Experimental | Drug: AZD2287, Drug: AZD2275, Drug: AZD2284Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive DL4 of AZD2284. |
| Part B: Cohort E1 | Experimental | Drug: AZD2287, Drug: AZD2275, Drug: AZD2284Participants will receive dose of AZD2284 determined by the earlier results. Expansion cohort may be opened to further characterize the safety and efficacy of the dose level. |
| Part B: Cohort E2 | Experimental | Drug: AZD2287, Drug: AZD2275, Drug: AZD2284Participants will receive dose of AZD2284 determined by the earlier results. Expansion cohort may be opened to further characterize the safety and efficacy of the dose level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- eria:
- • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- • Histologically confirmed diagnosis of adenocarcinoma of the prostate without strong clinical suspicion of majority neuroendocrine differentiation.
- • Must have had prior bilateral orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
- • At least one metastatic lesion present on baseline Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or bone scan obtained ≤ 28 days prior to the first dose of Investigational Medicinal Product (IMP). Participants may have non-measurable lesions including bone only metastases.
Key exclusion criteria (9 listed)
- • Treatment with any radiopharmaceutical within 6 weeks of the first dose of Investigational Medicinal Product (IMP).
- • Radiation therapy (RT) or external beam radiation therapy (EBRT) within 28 days prior to the first dose and all RT-related events have not recovered to Grade ≤ 1.
- • Administration of any systemic cytotoxic or investigational therapy ≤ 28 days of the first dose of IMP or 5 half-lives, whichever is shorter.
- • All prior treatment-related adverse events must have resolved to Grade ≤ 1.
- • Concurrent severe and/or uncontrolled illness not related to cancer and/or social situation that would limit compliance with study requirements.
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 |
|---|---|---|
| AZD2287Participants will receive AZD2287 | Drug | Part A: Cohort A1: AZD2287 (Hot only), Part A: Cohort A2: AZD2275 + AZD2287 (Cold +Hot), Part A: Cohort A3: AZD2275 + AZD2287 (Cold +Hot), Part B (Actinium-225 Dose Escalation): DL1: AZD2284, Part B (Actinium-225 Dose Escalation): DL2: AZD2284, Part B (Actinium-225 Dose Escalation): DL3: AZD2284, Part B (Actinium-225 Dose Escalation): DL4: AZD2284, Part B: Cohort E1, Part B: Cohort E2 |
| AZD2275Participants will receive AZD2275 | Drug | Part A: Cohort A2: AZD2275 + AZD2287 (Cold +Hot), Part A: Cohort A3: AZD2275 + AZD2287 (Cold +Hot), Part B (Actinium-225 Dose Escalation): DL1: AZD2284, Part B (Actinium-225 Dose Escalation): DL2: AZD2284, Part B (Actinium-225 Dose Escalation): DL3: AZD2284, Part B (Actinium-225 Dose Escalation): DL4: AZD2284, Part B: Cohort E1, Part B: Cohort E2 |
| AZD2284Participants will receive AZD2284 | Drug | Part A: Cohort A1: AZD2287 (Hot only), Part A: Cohort A2: AZD2275 + AZD2287 (Cold +Hot), Part A: Cohort A3: AZD2275 + AZD2287 (Cold +Hot), Part B (Actinium-225 Dose Escalation): DL1: AZD2284, Part B (Actinium-225 Dose Escalation): DL2: AZD2284, Part B (Actinium-225 Dose Escalation): DL3: AZD2284, Part B (Actinium-225 Dose Escalation): DL4: AZD2284, Part B: Cohort E1, Part B: Cohort E2 |
Primary outcome
Number of participants with adverse event (AEs)
Time frame: Part A: Up to Day 28; Part B: Up to 5 years
Number of participants with Dose Limiting Toxicities (DLTs)
Time frame: Part B: Up to 84 days of receiving AZD2284
Estimates of residence time
Time frame: Part A: Up to 8 days after a dose of AZD2287
Absorbed radiation doses for AZD2287 and AZD2284
Time frame: Part A: Up to 8 days after a dose of AZD2287; Part B: Up to 7 days after a dose of AZD2287
Compare organ uptake of AZD2287 with and without pre-dose administration of AZD2275
Time frame: Part A: Up to 8 days after a dose of AZD2287; Part B: Up to 7 days after a dose of AZD2287
Tumor uptake of AZD2287 in selected regions of interest on SPECT/CT and/or planar images
Time frame: Part A: Up to 8 days after a dose of AZD2287; Part B: Up to 7 days after a dose of AZD2287
13 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 12 months after the last dose of AZD2284
Proportion of participants with Prostate-Specific Antigen (PSA) 50
Time frame: Up to 12 months after the last dose of AZD2284
Proportion of participants with PSA90
Time frame: Up to 12 months after the last dose of AZD2284
Time to PSA50 response
Time frame: Up to 12 months after the last dose of AZD2284
Duration of Response (DoR)
Time frame: Up to 12 months after the last dose of AZD2284
Radiographic Progression Free Survival (rPFS)
Time frame: Up to 12 months after the last dose of AZD2284
Overall Survival (OS)
Time frame: Part A: Up to Day 28; Part B: Up to 5 years
Pharmacokinetic Clearance
Time frame: Part A: Up to Day 28; Part B: Up to 84 days
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Part A: Up to Day 28; Part B: Up to 84 days
Maximum observed drug concentration (Cmax)
Time frame: Part A: Up to Day 28; Part B: Up to 84 days
Half-life (t1/2)
Time frame: Part A: Up to Day 28; Part B: Up to 84 days
Changes in plasma concentrations of AZD2287 and AZD2284 following AZD2275 pre-administration compared to AZD2287 and AZD2284 alone
Time frame: Part A: Up to Day 28; Part B: Up to 84 days
Number of participants with positive antidrug antibodies (ADAs)
Time frame: Part A: Up to Day 28; Part B: Approximately 28 days after End of Treatment (EOT) visit
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 16 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes",indicatesthat AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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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.
AstraZeneca Clinical Study Information Center contact
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD2287, AZD2275 and AZD2284 in people with Metastatic Castration-Resistant Prostate Cancer, run by AstraZeneca at 16 sites in 3 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 22 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 16 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 16 sites in United States, South Africa, Australia. 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 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.
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?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse event (AEs) (time frame: Part A: Up to Day 28; Part B: Up to 5 years). The study lists 6 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 16 Oct 2026.