Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer

NCT07181161 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: D9520C000012024-520026-11-00
• Study Type: interventional
• Target: 177
• Locations: 10 countries
• Sites: 51

Brief Summary

The main purpose of this study is to assess the safety and tolerability of AZD0516 as monotherapy and/or in combination with other anti-cancer agents for treatment of metastatic prostate cancer.

Conditions

Metastatic Prostate Cancer

Keywords

Metastatic Castration-Resistant Prostate Cancer; Dose escalation study; Anti-cancer agents; Antibody-drug conjugate; Anti-Six-transmembrane epithelial antigen of the prostate 2 (anti-STEAP2); Metastatic castration resistant prostate cancer (mCRPC); AZD0516

Outcome Measures

Primary Outcomes (3)

• 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.

  From Day 1 up to approximately 3 years

• 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.

  From Day 1 up to end of DLT period (approximately 21 days)

• 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% decrease in PSA from baseline to the lowest post-baseline PSA result.

  Up to approximately 2 years

Secondary Outcomes (31)

• Module 1 and 2: Part A: Percentage of participants with PSA50 response rate

  Up to approximately 2 years

• Module 1 and 2: Parts A, B and C: Percentage of participants with PSA90 response rate

  Up to approximately 2 years

• Module 1 and 2: Parts A, B and C: Time to PSA 50 response (TTPSA50)

  Up to approximately 2 years

• Module 1 and 2: Parts A, B and C: Time to PSA response (TTPSA90)

  Up to approximately 2 years

• Module 1 and 2: Parts A, B and C: Duration of PSA response 50 (DoPSA50)

  Up to approximately 2 years

Study Arms (2)

Arm 1: AZD0516 monotherapy

EXPERIMENTAL

Participants with mCRPC will receive AZD0516 monotherapy.

Drug: AZD0516

Arm 2: AZD0516 + AZD9574

EXPERIMENTAL

Participants with mCRPC will receive AZD0516 in combination with AZD9574.

Drug: AZD0516; Drug: AZD9574

Interventions

AZD0516 DRUG

AZD0516 will be administered via intravenous infusion.

Arm 1: AZD0516 monotherapy; Arm 2: AZD0516 + AZD9574

AZD9574 DRUG

AZD9574 will be administered orally.

Arm 2: AZD0516 + AZD9574

Eligibility Criteria

• Age: 18 Years - 130 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the prostate. Focal high grade neuroendocrine features are permitted.
• Measurable PSA ≥ 1 μg/L (≥ 1 ng/mL).
• Surgically or medically castrated with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) within ≤ 28 days 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
• Life expectancy of at least 12 weeks in the opinion of the investigator
• Documented mCRPC progression at screening as assessed by the investigator with at least one of the following criteria:
• PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the screening visit should be ≥ 1 μg/L (1 ng/mL).
• 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).
• 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.

You may not qualify if:

• Cancer related spinal cord compression, or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent for at least 4 weeks prior to study enrolment.
• History of leptomeningeal carcinomatosis.
• Unresolved toxicities of Grade ≥ 2 (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
• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (51)

Research Site

Fayetteville, Arkansas, 72703, United States

RECRUITING

Research Site

Los Angeles, California, 90095, United States

RECRUITING

Research Site

Boston, Massachusetts, 02114, United States

RECRUITING

Research Site

Ann Arbor, Michigan, 48109, United States

RECRUITING

Research Site

Detroit, Michigan, 48201, United States

RECRUITING

Research Site

Buffalo, New York, 14263, United States

NOT YET RECRUITING

Research Site

New York, New York, 10065, United States

RECRUITING

Research Site

Providence, Rhode Island, 02906, United States

RECRUITING

Research Site

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Research Site

Houston, Texas, 77030, United States

RECRUITING

Research Site

Barretos, 14784-400, Brazil

NOT YET RECRUITING

Research Site

Porto Alegre, 90035-001, Brazil

NOT YET RECRUITING

Research Site

São Paulo, 01401-002, Brazil

NOT YET RECRUITING

Research Site

Changsha, 410013, China

NOT YET RECRUITING

Research Site

Chengdu, 610041, China

NOT YET RECRUITING

Research Site

Wuhan, 430022, China

NOT YET RECRUITING

Research Site

Lyon, 69008, France

WITHDRAWN

Research Site

Montpellier, 34298, France

WITHDRAWN

Research Site

Saint-Herblain, 44805, France

WITHDRAWN

Research Site

Suresnes, 92151, France

WITHDRAWN

Research Site

Villejuif, 94805, France

WITHDRAWN

Research Site

Milan, 20132, Italy

NOT YET RECRUITING

Research Site

Milan, 20133, Italy

NOT YET RECRUITING

Research Site

Milan, 20141, Italy

NOT YET RECRUITING

Research Site

Naples, 80131, Italy

NOT YET RECRUITING

Research Site

Roma, 00168, Italy

NOT YET RECRUITING

Research Site

Rozzano, 20089, Italy

NOT YET RECRUITING

Research Site

Chūōku, 104-0045, Japan

RECRUITING

Research Site

Kashiwa, 277-8577, Japan

NOT YET RECRUITING

Research Site

Kōtoku, 135-8550, Japan

RECRUITING

Research Site

Koszalin, 75-581, Poland

NOT YET RECRUITING

Research Site

Piotrkow Trybunalski, 97-300, Poland

NOT YET RECRUITING

Research Site

Przemyśl, 37-700, Poland

NOT YET RECRUITING

Research Site

Seoul, 03080, South Korea

NOT YET RECRUITING

Research Site

Seoul, 03722, South Korea

NOT YET RECRUITING

Research Site

Seoul, 06351, South Korea

NOT YET RECRUITING

Research Site

Seoul, 06591, South Korea

NOT YET RECRUITING

Research Site

Seoul, 5505, South Korea

NOT YET RECRUITING

Research Site

Barcelona, 08035, Spain

NOT YET RECRUITING

Research Site

Barcelona, 08036, Spain

NOT YET RECRUITING

Research Site

Barcelona, 08041, Spain

NOT YET RECRUITING

Research Site

L'Hospitalet de Llobregat, 08908, Spain

NOT YET RECRUITING

Research Site

Madrid, 28027, Spain

RECRUITING

Research Site

Pamplona, 31005, Spain

RECRUITING

Research Site

Santander, 39008, Spain

NOT YET RECRUITING

Research Site

Valencia, 46009, Spain

NOT YET RECRUITING

Research Site

Cambridge, CB2 0QQ, United Kingdom

NOT YET RECRUITING

Research Site

London, EC1A 7BE, United Kingdom

NOT YET RECRUITING

Research Site

London, SE1 9RT, United Kingdom

NOT YET RECRUITING

Research Site

Plymouth, PL6 8DH, United Kingdom

RECRUITING

Research Site

Sutton, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 18, 2029
• Study Completion (Estimated): January 18, 2029
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

JP (3); BR (3); CN (3); US (10); KR (5); IT (6); FR (5); PL (3); ES (8); GB (5)