A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Merck Sharp & Dohme LLC (industry)

Phase: 3

Start date: May 13, 2025

Planned enrollment: 1440

Trial ID: NCT06925737
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More trial details at ClinicalTrials.gov More info

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chevron Show for: Ifinatamab deruxtecan (MK-2400, DS-7300, I-DXd)

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Goal: Evaluate whether ifinatamab deruxtecan (I-DXd, MK-2400) improves overall survival and radiographic progression-free survival versus docetaxel in metastatic castration-resistant prostate cancer (mCRPC).

Patients: Adults with mCRPC with progression on androgen deprivation therapy or post-orchiectomy within 6 months, previously treated with 1–2 androgen receptor pathway inhibitors for at least 8 weeks, and no prior taxane for mCRPC. Key exclusions include prior steroid-requiring interstitial lung disease/pneumonitis, uncontrolled or significant cardiovascular disease, and prior taxane in the mCRPC setting.

Design: Global, randomized, open-label, active-controlled phase 3 trial comparing I-DXd to docetaxel. Blinded independent central review is used for radiographic endpoints. Planned enrollment is large to power co-primary OS and rPFS analyses.

Treatments: I-DXd: 12 mg/kg intravenously every 3 weeks. Ifinatamab deruxtecan is an antibody–drug conjugate targeting B7-H3 (CD276), a transmembrane protein highly expressed across many solid tumors with low expression in normal tissue. The humanized IgG1 antibody is linked via a cleavable tetrapeptide linker to a topoisomerase I inhibitor payload (DXd), designed to deliver cytotoxic payload selectively to tumor cells. In pretreated extensive-stage small cell lung cancer, I-DXd has shown objective response rates around 50% at the 12 mg/kg dose with median PFS approximately 5–6 months and OS around 12 months, with key toxicities including gastrointestinal and hematologic events and a risk of ILD/pneumonitis in roughly 9–12%. Docetaxel: 75 mg/m2 IV every 3 weeks plus daily prednisone per label, a standard chemotherapy option for mCRPC after ARPI exposure.

Outcomes: Co-primary endpoints are overall survival and radiographic progression-free survival by PCWG-modified RECIST 1.1 assessed by blinded independent central review. Secondary endpoints include time to first subsequent therapy, objective response rate, duration of response, time to pain progression, time to PSA progression, PSA response rate, time to first symptomatic skeletal-related event, incidence of adverse events, and treatment discontinuations due to adverse events.

Burden on patient: Moderate. As a phase 3 study with IV therapy every 3 weeks, participants will have regular clinic visits for infusions, routine labs, adverse event monitoring, and periodic radiographic assessments consistent with mCRPC standards. The investigational arm may require additional pulmonary monitoring given ILD/pneumonitis risk, but there is no indication of intensive pharmacokinetic sampling or mandatory serial biopsies. Travel and time commitments are comparable to standard chemotherapy schedules, with added vigilance for respiratory symptoms and standard imaging frequency for rPFS evaluations.

Last updated: Oct 2025

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Centro Oncologico de Integracion Regional. COIR ( Site 0130)

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Centro de Diagnostico Investigación y Tratamiento Oncológico (CeDIT) ( Site 0135)

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Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0131)

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San Juan, J5402DKL, Argentina

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Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0170)

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Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 1425)

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Nijmegen, Gelderland, 6525 GA, Netherlands

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Venlo, Limburg, 5912 BL, Netherlands

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Amsterdam, North Holland, 1066 CX, Netherlands

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Hoofddorp, North Holland, 2134 TM, Netherlands

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Hilversum, North Holland, 1212 VG, Netherlands

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Amersfoort, Utrecht, 3813 TZ, Netherlands

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Oslo, 0379, Norway

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Poznan, Greater Poland Voivodeship, 61-731, Poland

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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

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Katowice, Silesian Voivodeship, 40-519, Poland

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Cancercare Rondebosch Oncology ( Site 0771)

Cape Town, Gauteng, 7700, South Africa

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Seoul, 06351, South Korea

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Seoul, 03722, South Korea

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Hwasun Gun, Jeonranamdo, 58128, South Korea

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Songpagu, Seoul, 05505, South Korea

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Seocho-gu, Seoul, 06591, South Korea

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Donggu, Ulsan-Kwangyokshi, 44033, South Korea

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Majadahonda Madrid, Madrid, 28220, Spain

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Hospital General Universitario Gregorio Marañón ( Site 0812)

Madrid, Madrid, Comunidad de, 28009, Spain

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Karolinska Universitetssjukhuset Solna ( Site 0843)

Stockholm, Stockholm County, 171 64, Sweden

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Zurich, 8063, Switzerland

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Aarau, Canton of Aargau, 5001, Switzerland

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Hopitaux Universitaires de Geneve HUG. ( Site 0856)

Geneva, Canton of Geneva, 1211, Switzerland

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Chang Gung Medical Foundation - Kaohsiung ( Site 0872)

Kaohsiung City, 83301, Taiwan

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Taichung Veterans General Hospital ( Site 0873)

Taichung, 40705, Taiwan

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Taipei Veterans General Hospital ( Site 0875)

Taipei, 11217, Taiwan

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National Taiwan University Hospital ( Site 0870)

Taiwan, Taipei, 10002, Taiwan

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City of Hope Comprehensive Cancer Center ( Site 0049)

Duarte, California, 91010, United States

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City of Hope Lennar Foundation Cancer Center ( Site 0059)

Irvine, California, 92618, United States

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Moores Cancer Center ( Site 0010)

La Jolla, California, 92093, United States

No email / 858-822-6100

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Emory University School of Medicine- Grady Campus ( Site 0103)

Atlanta, Georgia, 30303, United States

No email / 404-727-6123

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Winship Cancer Institute, Emory University ( Site 0003)

Atlanta, Georgia, 30322, United States

No email / 404-778-4824

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Cancer and Hematology Centers of Western Michigan ( Site 0015)

Grand Rapids, Michigan, 49503, United States

No email / 616-399-6500

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HealthPartners Cancer Center at Regions Hospital ( Site 0052)

Saint Paul, Minnesota, 55101, United States

No email / 612-341-4800

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HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0032)

Saint Louis Park, Minnesota, 55426, United States

No email / 612-341-4800

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St. Vincent Frontier Cancer Center-Research ( Site 0037)

Billings, Montana, 59102, United States

No email / 406-238-6290

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Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)

Omaha, Nebraska, 68130, United States

No email / 402-334-4773

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Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island ( Site 0076)

Grand Island, Nebraska, 68803, United States

No email / 402-334-4773

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John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)

Hackensack, New Jersey, 07601, United States

No email / 551-996-5900

Status: Recruiting

UT Southwestern Medical Center ( Site 0039)

Dallas, Texas, 75390, United States

No email / 972-332-4682

Status: Recruiting

Blue Ridge Cancer Care ( Site 0024)

Roanoke, Virginia, 24014, United States

No email / 540-982-0237

Status: Recruiting

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