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Clinical Trials in the UK / NCT06925737
Recruiting Phase 3

A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)

NCT06925737 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2025-05-13
Last updated
2026-09-11

Condition(s) studied

Prostate CancerProstatic Neoplasms

Investigational drug(s) / intervention(s)

Ifinatamab deruxtecanDocetaxelPrednisoneRescue Medication

Ifinatamab deruxtecan: Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment

Docetaxel: Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment

Prednisone: Oral tablet administered once per day or per approved product label

Rescue Medication: Before administering each dose of I-DXd, premedication is required for prevention of nausea and vomiting with a 2 or 3 drug combination regimen (eg, corticosteroids with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist and other drugs as indicated) per approved product label

Study summary

Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology * Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening * Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography (CT)/magnetic resonance imaging (MRI) * Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment * Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy * Has recovered from adverse events (AEs) due to previous anticancer therapies Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Is unable to swallow tablets/capsules * Has any of the following indicators of interstitial lung disease (ILD)/pneumonitis: 1. Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids 2. Has current ILD/pneumonitis 3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * Has uncontrolled or significant cardiovascular disease * Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC) * Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities * Has a "superscan" bone scan

Primary outcome measure(s)

Trial sites (296)

FacilityCityRegionStatus
Mayo Clinic in Arizona - Phoenix ( Site 0044) Phoenix Arizona Recruiting
City of Hope Comprehensive Cancer Center ( Site 0049) Duarte California Recruiting
City of Hope Lennar Foundation Cancer Center ( Site 0059) Irvine California Recruiting
Moores Cancer Center ( Site 0010) La Jolla California Recruiting
Veterans Affairs Long Beach Healthcare System ( Site 0058) Long Beach California Recruiting
Cedars-Sinai Medical Center ( Site 0068) Los Angeles California Recruiting
UCLA Hematology/Oncology - Santa Monica ( Site 0002) Los Angeles California Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0006) Orange California Recruiting
Stanford Cancer Center ( Site 0046) Palo Alto California Recruiting
Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0053) Aurora Colorado Recruiting
Yale-New Haven Hospital-Yale Cancer Center ( Site 0050) New Haven Connecticut Recruiting
Veterans Affairs Connecticut Healthcare System ( Site 0062) West Haven Connecticut Recruiting
The GW Medical Faculty Associates ( Site 0057) Washington D.C. District of Columbia Recruiting
Washington DC Veterans Affairs Medical Center ( Site 0056) Washington D.C. District of Columbia Recruiting
Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0077) Jacksonville Florida Recruiting
Emory University School of Medicine- Grady Campus ( Site 0103) Atlanta Georgia Recruiting
Winship Cancer Institute, Emory University ( Site 0003) Atlanta Georgia Recruiting
Rush University Medical Center-Hematology and Oncology ( Site 0028) Chicago Illinois Recruiting
University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0063) Chicago Illinois Recruiting
University of Kentucky Chandler Medical Center ( Site 0048) Lexington Kentucky Recruiting
Greenebaum Comprehensive Cancer Center ( Site 0021) Baltimore Maryland Recruiting
Beth Israel Deaconess Medical Center ( Site 0043) Boston Massachusetts Recruiting
Dana Farber Cancer Institute ( Site 0012) Boston Massachusetts Recruiting
University of Michigan ( Site 0005) Ann Arbor Michigan Recruiting
Henry Ford Hospital ( Site 0035) Detroit Michigan Recruiting
Cancer and Hematology Centers of Western Michigan ( Site 0015) Grand Rapids Michigan Recruiting
Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0078) Rochester Minnesota Recruiting
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0032) Saint Louis Park Minnesota Recruiting
HealthPartners Cancer Center at Regions Hospital ( Site 0052) Saint Paul Minnesota Recruiting
St. Vincent Frontier Cancer Center-Research ( Site 0037) Billings Montana Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island ( Site 0076) Grand Island Nebraska Completed
Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026) Omaha Nebraska Completed
Comprehensive Cancer Centers of Nevada ( Site 0082) Las Vegas Nevada Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016) Hackensack New Jersey Recruiting
University of New Mexico Comprehensive Cancer Center ( Site 0022) Albuquerque New Mexico Recruiting
Icahn School of Medicine at Mount Sinai ( Site 0009) New York New York Recruiting
Great Lakes Cancer Care ( Site 0047) Williamsville New York Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0061) Columbus Ohio Recruiting
VA Portland Health Care System ( Site 0038) Portland Oregon Recruiting
Perelman Center for Advanced Medicine ( Site 0067) Philadelphia Pennsylvania Recruiting

+ 256 more sites — see the full list on the official registry below.

On this site

📄 Deltasone (prednisone) drug profile →

More Merck Sharp & Dohme LLC trials in the UK

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06925737 on ClinicalTrials.gov ↗ ← All trials in the UK