Recruiting
Phase 3

AZD2265

Sponsor:

AstraZeneca

Code:

NCT07611110

Conditions

Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])

Cabazitaxel

Abiraterone

Enzalutamide

Apalutamide

Study Details

Brief summary:

The intention of the study is to demonstrate superiority of AZD2265 relative to standard of care treatments by assessment of radiographic progression-free survival (rPFS) and overall survival (OS) in participants with mCRPC.

Conditions

Metastatic Castration-resistant Prostate Cancer

Study ID

NCT07611110

Start date

May 4, 2026

Status verified date

Aug, 2026

Completion date

Jun 6, 2030

Anticipated

Primary completion date

Jun 4, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥ 18 years of age.
  • Diagnosis of adenocarcinoma of prostate.
  • Must have had prior orchiectomy and/or ongoing ADT and a castrate level of plasma/serum testosterone.
  • Progressive mCRPC following the most recent treatment at the time of study entry, with at least 1 metastatic lesion (measurable and/or non-measurable) that is suitable for repeated assessment by CT and/or MRI and/or bone scan.
  • Previously treated with at least 2 cycles of PSMA-directed β-emitting radioconjugate.
  • Previously treated with at least 1 taxane-based chemotherapy regimen for either metastatic hormone-sensitive prostate cancer or CRPC.
  • Previously treated with at least 1 ARPI (eg, enzalutamide, abiraterone, etc.).
  • Positive PSMA PET/CT scans, obtained with PSMA ligands (⁶⁸Ga-PSMA-11 or ¹⁸F-DCFPyL).
  • ECOG performance status of 0 to 2.
  • Adequate organ and bone marrow function as described in study protocol.
  • Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.
  • Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.

Exclusion Criteria:

  • Prior treatment with an α-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted).
  • Progression on PSMA-directed β-emitting radioconjugate prior to the administration of Cycle 3.
  • Receipt of > 6 cycles of PSMA-directed β-emitting therapeutic RC.
  • History of another primary malignancy, with exceptions.
  • Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, with exceptions.
  • Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
  • Clinically significant ECG abnormalities, with exceptions.

Study Design

Enrollment

670 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

Actinium (225Ac) zadavotide guraxetan (AZD2265 \[FPI-2265\])

active comparator: Arm B

Investigator's choice of cabazitaxel, ARPI, or radium-223

Interventions

Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])

IV

Cabazitaxel

IV in combination with oral prednisone/prednisolone

Abiraterone

Oral in combination with prednisone/prednisolone

Enzalutamide

Oral

Apalutamide

Oral; Available only to participants randomized under Protocol Version 2.0; not offered to participants randomized under Protocol Version 3.0 (04 June 2026)

Darolutamide

Oral; Available only to participants randomized under Protocol Version 2.0; not offered to participants randomized under Protocol Version 3.0 (04 June 2026)

Deutenzalutamide

Oral; available in China only

Radium-223

IV

Primary outcome measure

  • Radiographic Progression-Free Survival (rPFS) [ Time Frame: From randomization until first radiographic progression per RECIST 1.1/PCWG3 by BICR, or death from any cause, whichever occurs first (up to approximately 33 months) ]
  • Overall Survival (OS) [ Time Frame: From randomization until death from any cause (up to approximately 33 months) ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Dothan, Alabama, United States, 36303

Research Site

Recruiting

Newport Beach, California, United States, 92660

Research Site

Recruiting

Miami, Florida, United States, 33165

Research Site

Recruiting

Metairie, Louisiana, United States, 70006

Research Site

Recruiting

Omaha, Nebraska, United States, 68130

Research Site

Recruiting

Houston, Texas, United States, 77042

Research Site

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

AstraZeneca

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • AZD2265; prostate cancer; mCRPC; PSMA; FPI-2265; 225Ac; Actinium (225Ac) zadavotide guraxetan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.