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AZD0754

Phase 1

Metastatic Prostate Cancer | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Feb 23, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

AZD0754 · 1 trial · 1 indication

Phase 1 1
NCT06267729Study of AZD0754 in Participants With Metastatic Prostate CancerMetastatic Prostate Cancer
RECRUITING60 Analytics
PHASE1RECRUITING
Study of AZD0754 in Participants With Metastatic Prostate Cancer
Metastatic Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of participants with Dose-limiting Toxicity (DLTs)/DLT-like events, Adverse Events (AEs), including Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs).
Through study completion, an average of 2 years

Determine if treatment with AZD0754 is safe and tolerable through assessment of DLTs/DLT-like events, AEs, AESIs, SAEs, and changes from baseline in laboratory parameters, vital signs, and ECGs.

Secondary Endpoints

Prostate-specific antigen (PSA) response rate - PSA50
Through study completion, an average of 2 years
PSA response rate - PSA90
Through study completion, an average of 2 years
Duration of PSA Response (DoPSA50, DoPSA90)
Through study completion, an average of 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD0754EXPERIMENTALAZD0754 monotherapy for treatment of participants with metastatic prostate cancer.
AZD2287EXPERIMENTALAZD2287 is a novel imaging agent for STEAP2

Interventions

NameTypeDescription
AZD0754BIOLOGICALSubjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce AZD0754. During AZD0754 production, subjects may receive bridging therapy for disease control. Upon successful generation of AZD0754 product, subjects will receive treatment with AZD0754 therapy. Study treatment will include lymphodepleting chemotherapy. After lymphodepleting chemotherapy AZD0754 is administered intravenously and patients will be required to stay at the hospital for a protocol specified monitoring period.
AZD2287BIOLOGICALThis is an Optional arm of the study, which subjects will separately consent to if they would like to participate. Subjects will receive doses of a radioactive imaging agent called AZD2287 followed by SPECT/CT imaging scans at two time points.
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Eligibility Criteria

Age Range18 Years to 130 Years
SexMALE
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: Age 1. Participant must be 18 years or older at the time of signing the informed consent form. Type of Participant and Disease Characteristics 2. Participants with: 1. A histologically confirmed diagnosis of metastatic adenocarcinoma of the prostate without known neuroe...

Countries:United StatesAustraliaSpain
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Competitive Landscape -Prostate Cancer 254 trials (matched to "Metastatic Prostate Cancer")

Frequently asked questions about AZD0754

What is AZD0754 used for?

AZD0754 is an investigational monoclonal antibody being developed for the treatment of metastatic prostate cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing AZD0754?

AZD0754 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical trials for metastatic prostate cancer.

What phase is AZD0754 in?

AZD0754 is in Phase 1 clinical development. It is an investigational drug being studied in a Phase 1 trial for metastatic prostate cancer, and it has not yet been approved for commercial use.

What clinical trials is AZD0754 in?

AZD0754 is being studied in a Phase 1 clinical trial with the identifier NCT06267729. This trial is recruiting participants with metastatic prostate cancer and is being conducted in the United States, Australia, and Spain.

Is AZD0754 a monoclonal antibody?

Yes, AZD0754 is a monoclonal antibody. It is being investigated as a potential treatment for metastatic prostate cancer and is currently in Phase 1 clinical development.