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Clinical Trials in Turkey / 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 Turkey tracker
Phase
Phase 3
Started
2025-05-13
Last updated
2026-09-17

Condition(s) studied

Prostate CancerProstatic Neoplasms

Investigational drug(s) / intervention(s)

Ifinatamab deruxtecan →Docetaxel →Prednisone →Rescue 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 (298)

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

+ 258 more sites — see the full list on the official registry below.

On this site

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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 Turkey