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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Investigational Drug AI Analysis

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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Terni, 05100, Italy

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Rome, Roma, 00128, Italy

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Fukuoka, 812-0033, Japan

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Kagoshima, 890-8520, Japan

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Fukuoka, 812-8582, Japan

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Nagano, 381-8551, Japan

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Nagasaki, 852-8501, Japan

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Kumamoto, 860-0008, Japan

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Niigata Cancer Center Hospital ( Site 1529)

Niigata, 951-8566, Japan

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Tokushima University Hospital ( Site 1513)

Tokushima, 770-8503, Japan

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University Hospital,Kyoto Prefectural University of Medicine ( Site 1525)

Kyoto, 602-8566, Japan

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Nagoya University Hospital ( Site 1508)

Nagoya, Aichi-ken, 466-8560, Japan

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Toho University Sakura Medical Center ( Site 1503)

Sakura, Chiba, 285-8741, Japan

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Ehime University Hospital ( Site 1514)

Tōon, Ehime, 791-0295, Japan

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Hospital of the University of Occupational and Environmental Health, Japan ( Site 1510)

Kitakyushu, Fukuoka, 807-8556, Japan

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Kurume University Hospital ( Site 1516)

Kurume, Fukuoka, 830-0011, Japan

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Hokkaido University Hospital ( Site 1500)

Sapporo, Hokkaido, 060-8648, Japan

No email / +81-11-716-1161

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Sapporo Medical University Hospital ( Site 1501)

Sapporo, Hokkaido, 060-8543, Japan

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Kobe University Hospital ( Site 1511)

Kobe, Hyōgo, 650-0017, Japan

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Kanazawa Medical University Hospital ( Site 1507)

Kahoku-gun, Ishikawa-ken, 920-0293, Japan

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Shonan Kamakura General Hospital ( Site 1530)

Kamakura, Kanagawa, 247-8533, Japan

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Oita University Hospital ( Site 1521)

Yufu, Oita Prefecture, 879-5593, Japan

No email / +81-97-549-4411

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University of the Ryukyus Hospital ( Site 1519)

Ginowan, Okinawa, 901-2725, Japan

No email / +81-98-894-1455

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Bell Land General Hospital ( Site 1509)

Sakai, Osaka, 599-8247, Japan

No email / +81-72-234-2001

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Dokkyo Medical University Saitama Medical Center ( Site 1502)

Koshigaya, Saitama, 343-8555, Japan

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Hamamatsu University Hospital ( Site 1520)

Hamamatsu, Shizuoka, 431-3192, Japan

No email / +81-53-435-2111

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The Jikei University Hospital ( Site 1504)

Minato, Tokyo, 105-8471, Japan

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Tokyo Women's Medical University ( Site 1505)

Shinjuku, Tokyo, 162-8666, Japan

No email / +81-3-3353-8111

Status: Recruiting

Yamaguchi University Hospital ( Site 1522)

Ube, Yamaguchi, 755-8505, Japan

No email / +81-836-22-2111

Status: Recruiting

University of Yamanashi Hospital ( Site 1506)

Chūō, Yamanashi, 409-3898, Japan

No email / +81-55-273-9325

Status: Recruiting

Martini Ziekenhuis ( Site 0621)

Groningen, 9728 NT, Netherlands

No email / 050-5246311

Status: Recruiting

St. Antonius Ziekenhuis, locatie Utrecht ( Site 0620)

Utrecht, 3543 AZ, Netherlands

No email / +31883205148

Status: Recruiting

UMC St. Radboud ( Site 0601)

Nijmegen, Gelderland, 6525 GA, Netherlands

No email / 0031243610353

Status: Recruiting

Maastricht UMC+ ( Site 0612)

Maastricht, Limburg, 6229 HX, Netherlands

No email / 043-3877025

Status: Recruiting

VieCuri Medisch Centrum, locatie Venlo ( Site 0610)

Venlo, Limburg, 5912 BL, Netherlands

No email / 077-3205634

Status: Recruiting

Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0602)

Amsterdam, North Holland, 1066 CX, Netherlands

No email / 003120512 9111

Status: Recruiting

Spaarne Gasthuis - Hoofddorp ( Site 0608)

Hoofddorp, North Holland, 2134 TM, Netherlands

No email / +31232245802

Status: Recruiting

Tergooiziekenhuizen, locatie Hilversum ( Site 0619)

Hilversum, North Holland, 1212 VG, Netherlands

No email / +31887535153

Status: Recruiting

Ziekenhuisgroep Twente, locatie Almelo ( Site 0615)

Hengelo, Overijssel, 7555 DL, Netherlands

No email / +31887083782

Status: Recruiting

Erasmus Medisch Centrum ( Site 0611)

Rotterdam, South Holland, 3015 GD, Netherlands

No email / 0031107041906

Status: Recruiting

Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 0600)

Schiedam, South Holland, 3118 JH, Netherlands

No email / +31108931441

Status: Recruiting

Haga Ziekenhuis locatie Leyweg ( Site 0607)

The Hague, South Holland, 2545 AA, Netherlands

No email / 070-210 2143

Status: Recruiting

Meander Medisch Centrum ( Site 0604)

Amersfoort, Utrecht, 3813 TZ, Netherlands

No email / +3133850 7278

Status: Recruiting

Oslo universitetssykehus, Radiumhospitalet ( Site 0653)

Oslo, 0379, Norway

No email / +4722934000

Status: Recruiting

Akershus Universitetssykehus-Onkologisk avdeling ( Site 0650)

Lorenskog, Akershus, 1474, Norway

No email / 004767960000

Status: Recruiting

Sykehuset Innlandet HF Gjøvik ( Site 0652)

Gjøvik, Oppland, 2819, Norway

No email / 004791506200

Status: Recruiting

St. Olavs Hospital-Kreftklinikken ( Site 0651)

Trondheim, Sor-Trondelag, 7030, Norway

No email / +4772825810

Status: Recruiting

IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0666)

Lima, 15036, Peru

No email / +5112241598

Status: Recruiting

Instituto Neuro Cardiovascular de las Americas ( Site 0668)

Lima, 15047, Peru

No email / 51991366612

Status: Recruiting

Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 0688)

Poznan, Greater Poland Voivodeship, 61-731, Poland

No email / +48500 799 053

Status: Recruiting

Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 0696)

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

No email / +48523743589

Status: Recruiting

Pratia MCM Krakow ( Site 0692)

Krakow, Lesser Poland Voivodeship, 30-727, Poland

No email / +48122954100

Status: Recruiting

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0686)

Siedlce, Masovian Voivodeship, 08-110, Poland

No email / +48256403300

Status: Recruiting

Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie ( Site 0685)

Warsaw, Masovian Voivodeship, 02-781, Poland

No email / +48225462331

Status: Recruiting

Pratia Onkologia Katowice ( Site 0693)

Katowice, Silesian Voivodeship, 40-519, Poland

No email / +48327462500

Status: Recruiting

National Cancer Centre Singapore ( Site 0760)

Singapore, Central Singapore, 168583, Singapore

No email / +6564368000

Status: Recruiting

Cancercare Rondebosch Oncology ( Site 0771)

Cape Town, Gauteng, 7700, South Africa

No email / +27219443700

Status: Recruiting

Curo Oncology Centre ( Site 0779)

Pretoria, Gauteng, 0084, South Africa

No email / +27123356771

Status: Recruiting

LIFE GROENKLOOF ( Site 0777)

Pretoria, Gauteng, 0181, South Africa

No email / +27123466701

Status: Recruiting

Wilgers Oncology Centre ( Site 0775)

Pretoria, Gauteng, 0081, South Africa

No email / +27 83 441 4889

Status: Recruiting

Wits Clinical Research ( Site 0776)

Johannesburg, Gauteng, 2193, South Africa

No email / +27113390600

Status: Recruiting

Samsung Medical Center ( Site 0792)

Seoul, 06351, South Korea

No email / 82-2-3410-1767

Status: Recruiting

Severance Hospital Yonsei University Health System ( Site 0790)

Seoul, 03722, South Korea

No email / 82-2-2228-8138

Status: Recruiting

Chonnam National University Hwasun Hospital ( Site 0794)

Hwasun Gun, Jeonranamdo, 58128, South Korea

No email / 82-61-379-7623

Status: Recruiting

Asan Medical Center ( Site 0791)

Songpagu, Seoul, 05505, South Korea

No email / 82-2-3010-6961

Status: Recruiting

The Catholic University of Korea St. Mary s Hospital ( Site 0795)

Seocho-gu, Seoul, 06591, South Korea

No email / 82-2-2258-6806

Status: Recruiting

Ulsan University Hospital ( Site 0793)

Donggu, Ulsan-Kwangyokshi, 44033, South Korea

No email / 82-52-230-1413

Status: Recruiting

Fundación Instituto Valenciano de Oncología ( Site 0821)

Valencia, 46009, Spain

No email / +34 96 111 42 29

Status: Recruiting

Hospital Lucus Augusti ( Site 0813)

Lugo, 27003, Spain

No email / +343982296459

Status: Recruiting

Hospital Universitario Quiron Madrid ( Site 0823)

Madrid, 28223, Spain

No email / +34914521987

Status: Recruiting

Hospital Universitario Reina Sofia ( Site 0816)

Córdoba, 14004, Spain

No email / +34 957011464

Status: Recruiting

Hospital Universitario Virgen de Valme ( Site 0819)

Seville, 41014, Spain

No email / +34955015273

Status: Recruiting

Hospital Vall D Hebron ( Site 0814)

Barcelona, 08035, Spain

No email / +34 93 4894374

Status: Recruiting

Hospital del Mar ( Site 0822)

Barcelona, 08003, Spain

No email / 34932483860

Status: Recruiting

Hospital Universitario Marqués de Valdecilla ( Site 0810)

Santander, Cantabria, 39008, Spain

No email / +34 +349422025155 25

Status: Recruiting

CHUS - Hospital Clinico Universitario ( Site 0815)

Santiago de Compostela, La Coruna, 15706, Spain

No email / +34 663 609 134

Status: Recruiting

HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 0811)

Majadahonda Madrid, Madrid, 28220, Spain

No email / +34911917418

Status: Recruiting

Hospital General Universitario Gregorio Marañón ( Site 0812)

Madrid, Madrid, Comunidad de, 28009, Spain

No email / +34 914269393

Status: Recruiting

Skånes Universitetssjukhus Malmö ( Site 0841)

Malmo, Skåne County, 20502, Sweden

No email / 040331000

Status: Recruiting

Karolinska Universitetssjukhuset Solna ( Site 0843)

Stockholm, Stockholm County, 171 64, Sweden

No email / 46812370000

Status: Recruiting

Södersjukhuset ( Site 0844)

Stockholm, Stockholm County, 11883, Sweden

No email / +46812361000

Status: Recruiting

Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 0840)

Uppsala, Östergötland County, 751 85, Sweden

No email / +46186110000

Status: Recruiting

HFR Fribourg - Hôpital Cantonal ( Site 0858)

Fribourg, 1708, Switzerland

No email / +41263062260

Status: Recruiting

Stadtspital Triemli ( Site 0855)

Zurich, 8063, Switzerland

No email / +41444163505

Status: Recruiting

Kantonspital Aarau ( Site 0857)

Aarau, Canton of Aargau, 5001, Switzerland

No email / +41628386050

Status: Recruiting

University Hospital Basel ( Site 0859)

Basel, Canton of Basel-City, 4031, Switzerland

No email / +41612655074

Status: Recruiting

Hopitaux Universitaires de Geneve HUG. ( Site 0856)

Geneva, Canton of Geneva, 1211, Switzerland

No email / +41223722901

Status: Recruiting

Chang Gung Medical Foundation - Kaohsiung ( Site 0872)

Kaohsiung City, 83301, Taiwan

No email / +88677317123x2270

Status: Recruiting

Taichung Veterans General Hospital ( Site 0873)

Taichung, 40705, Taiwan

No email / +886423592525x5121

Status: Recruiting

Taipei Veterans General Hospital ( Site 0875)

Taipei, 11217, Taiwan

No email / +88622871 2121

Status: Recruiting

National Taiwan University Hospital ( Site 0870)

Taiwan, Taipei, 10002, Taiwan

No email / +88623123456

Status: Recruiting

Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 0887)

Dusit, Bangkok, 10300, Thailand

No email / +6622443461

Status: Recruiting

Faculty of Medicine Siriraj Hospital ( Site 0885)

Bangkoknoi, Bangkok, 10700, Thailand

No email / +6624194488

Status: Recruiting

Mayo Clinic in Arizona - Phoenix ( Site 0044)

Phoenix, Arizona, 85054, United States

No email / 855-776-0015

Status: Recruiting

Cedars-Sinai Medical Center ( Site 0068)

Los Angeles, California, 90048, United States

No email / 310-423-7600

Status: Recruiting

City of Hope Comprehensive Cancer Center ( Site 0049)

Duarte, California, 91010, United States

No email / 626-256-4673

Status: Recruiting

City of Hope Lennar Foundation Cancer Center ( Site 0059)

Irvine, California, 92618, United States

No email / 626-256-4673

Status: Recruiting

Moores Cancer Center ( Site 0010)

La Jolla, California, 92093, United States

No email / 858-822-6100

Status: Recruiting

Washington DC Veterans Affairs Medical Center ( Site 0056)

Washington D.C., District of Columbia, 20422, United States

No email / 202-745-8000

Status: Recruiting

Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0077)

Jacksonville, Florida, 32224, United States

No email / 855-776-0015

Status: Recruiting

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

Atlanta, Georgia, 30303, United States

No email / 404-727-6123

Status: Recruiting

Winship Cancer Institute, Emory University ( Site 0003)

Atlanta, Georgia, 30322, United States

No email / 404-778-4824

Status: Recruiting

University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0063)

Chicago, Illinois, 60612, United States

No email / 312-355-1625

Status: Recruiting

University of Kentucky Chandler Medical Center ( Site 0048)

Lexington, Kentucky, 40536, United States

No email / 866-340-4488

Status: Recruiting

Beth Israel Deaconess Medical Center ( Site 0043)

Boston, Massachusetts, 02215, United States

No email / 617-667-2100

Status: Recruiting

Dana Farber Cancer Institute ( Site 0012)

Boston, Massachusetts, 02215, United States

No email / 617-632-6049

Status: Recruiting

Cancer and Hematology Centers of Western Michigan ( Site 0015)

Grand Rapids, Michigan, 49503, United States

No email / 616-399-6500

Status: Recruiting

Henry Ford Hospital ( Site 0035)

Detroit, Michigan, 48202, United States

No email / 313-725-7920

Status: Recruiting

University of Michigan ( Site 0005)

Ann Arbor, Michigan, 48109, United States

No email / 734-647-8902

Status: Recruiting

HealthPartners Cancer Center at Regions Hospital ( Site 0052)

Saint Paul, Minnesota, 55101, United States

No email / 612-341-4800

Status: Recruiting

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

Saint Louis Park, Minnesota, 55426, United States

No email / 612-341-4800

Status: Recruiting

Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0078)

Rochester, Minnesota, 55905, United States

No email / 855-776-0015

Status: Recruiting

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

Billings, Montana, 59102, United States

No email / 406-238-6290

Status: Recruiting

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

Omaha, Nebraska, 68130, United States

No email / 402-334-4773

Status: Recruiting

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

Grand Island, Nebraska, 68803, United States

No email / 402-334-4773

Status: Recruiting

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

Hackensack, New Jersey, 07601, United States

No email / 551-996-5900

Status: Recruiting

Great Lakes Cancer Care ( Site 0047)

Williamsville, New York, 14221, United States

No email / 716-884-3000

Status: Recruiting

Icahn School of Medicine at Mount Sinai ( Site 0009)

New York, New York, 10029, United States

No email / 212-241-6756

Status: Recruiting

Abramson Cancer Center - Penn Medicine ( Site 0079)

Philadelphia, Pennsylvania, 19106, United States

No email / 215-829-6088

Status: Recruiting

Perelman Center for Advanced Medicine ( Site 0067)

Philadelphia, Pennsylvania, 19104, United States

No email / 215-360-0737

Status: Recruiting

Memphis VA Medical Center ( Site 0072)

Memphis, Tennessee, 38105, United States

No email / 901-523-8990

Status: Recruiting

SCRI Oncology Partners ( Site 0074)

Nashville, Tennessee, 37203, United States

No email / 615-329-7640

Status: Recruiting

UT Southwestern Medical Center ( Site 0039)

Dallas, Texas, 75390, United States

No email / 972-332-4682

Status: Recruiting

University of Texas-MD Anderson Cancer Center ( Site 0055)

Houston, Texas, 77030, United States

No email / 877-632-6789

Status: Recruiting

Blue Ridge Cancer Care ( Site 0024)

Roanoke, Virginia, 24014, United States

No email / 540-982-0237

Status: Recruiting

VA Puget Sound Health Care System ( Site 0054)

Seattle, Washington, 98108, United States

No email / 206-762-1010

Status: Recruiting

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