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A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Metastatic Prostate Cancer (SEACLIFF) (SEACLIFF)

Phase I/II Study of AZD0516 as Monotherapy and in Combination in Participants with Metastatic Prostate Cancer (SEACLIFF) (SEACLIFF)

Hibi Kazushige

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

RD-clinical-information-Japan@astrazeneca.com

Hibi Kazushige

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

+81-6-4802-3600

RD-clinical-information-Japan@astrazeneca.com

Recruiting

Jan. 30, 2026

Interventional

randomized controlled trial

open(masking not used)

dose comparison control

single assignment

treatment purpose

- Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the prostate. Focal high grade neuroendocrine features are permitted.

- Measurable PSA 1 mcg/L or more (1 ng/mL or more).

- Surgically or medically castrated with serum testosterone levels 50 ng/dL or less (1.75 nmol/L or less) within 28 days or less before treatment allocation. Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) modulator for participants who have not undergone bilateral orchiectomy must be initiated at least 2 weeks prior to consent and must continue throughout the study.

- Eastern cooperative oncology group (ECOG) performance status of 0 or 1.

- Adequate organ and marrow function in the absence of blood transfusion or growth factor support (within 21 days prior to the scheduled first dose of study intervention).

- Provision of baseline archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumour sample is mandatory.

- Documented current evidence of metastatic prostate cancer

- Documented mCRPC progression at screening as assessed by the investigator with at least one of the following criteria:

1. PSA progression defined by a minimum of 3 rising PSA levels with an interval of or more 1 week between each determination. The PSA value at the screening visit should be 1 mcg/L or more (1 ng/mL).

2. Radiographic disease progression in soft tissue based on response evaluation criteria in solid tumors (RECIST) v1.1 criteria with or without PSA progression as per prostate cancer working group 3 (PCWG3).

3. Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on a bone scan as per PCWG3 with or without PSA progression.

- Cancer related spinal cord compression, or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of more 10 mg prednisone/day or equivalent for at least 4 weeks prior to study enrolment.

- History of leptomeningeal carcinomatosis.

- Unresolved toxicities of Grade 2 or more (National Cancer Institute Common Terminology Criteria for Adverse Events v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy).

- Uncontrolled intercurrent illness within the last 12 months.

- Cardiovascular disorder (History of arrhythmia, uncontrolled hypertension, symptomatic hypotension, history of brain perfusion problems, symptomatic heart failure, prior or current cardiomyopathy, severe valvular heart disease)

- History of malignancy

- History of non-infectious interstitial lung disease (ILD)/pneumonitis

- Active infection exclusions, including tuberculosis and infections with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).

- Any known predisposition to bleeding

- Clinically severe pulmonary compromise

- Participants with Myelodysplastic syndrome (MDS)/Acute Myeloid Leukemia (AML) or with features suggestive of MDS/AML.

- Previous treatment with a STEAP2 targeting modality, chemotherapeutic agent that inhibits topoisomerase activity or metabolic enzymes.

Both

Metastatic Prostate Cancer

Experimental: Arm 1: AZD0516 monotherapy
Participants with mCRPC will receive AZD0516 monotherapy.
Experimental: Arm 2: AZD0516 + AZD9574
Participants with mCRPC will receive AZD0516 in combination with AZD9574.

- Module 1 and 2: Parts A and B: Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interests (AESIs)

Part A: To assess the safety and tolerability and to determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion (RDE) of AZD0516 as monotherapy and in combination with anti-cancer agents.

Part B: To assess the safety and tolerability of AZD0516 as monotherapy and in combination with anti-cancer agents.

- Module 1 and 2: Part A: Number of participants with Dose Limiting Toxicities (DLTs)
To assess the safety and tolerability of AZD0516 as monotherapy and in combination with anti-cancer agents.

- Module 1: Parts B and C and Module 2: Part B: Percentage of participants with Prostate-Specific Antigen (PSA) 50 response rate
The PSA50 response rate is defined as the percentage of participants achieving 50% or more decrease in PSA from baseline to the lowest post-baseline PSA result.

Nov. 11, 2025

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, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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