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New drug combo takes on Hard-to-Treat prostate cancer

NCT ID NCT06863272

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 8 times

Summary

This study tests a new drug called ifinatamab deruxtecan (I-DXd), given alone or with other treatments, in men with metastatic castration-resistant prostate cancer (mCRPC) that has worsened despite hormone therapy. The trial aims to find safe doses and see if the drug can lower PSA levels and shrink tumors. About 360 participants will take part across multiple sites.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ifinatamab deruxtecan (I-DXd), docetaxel, MK-5684, abiraterone, enzalutamide
What this could lead to
If it works, this could point toward a new treatment option for men with advanced prostate cancer that has stopped responding to hormone therapy.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not prove effective or safe enough for wider use. Side effects could be serious, including severe toxicities.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 before Screening * Has current evidence of distant metastatic disease * Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after treatment * Participants receiving bone resorptive therapy (including, but not limited to bisphosphonate or denosumab) must have been on stable doses for ≥4 weeks before allocation/randomization * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 10 days before allocation/randomization * Has prior treatment with poly-ADP-ribose polymerase inhibitors (PARPi) if indicated by local approved regimen or were deemed ineligible to receive PARPi by the investigator Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), current ILD, clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out * Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * Uncontrolled or significant cardiovascular disease * History of pituitary dysfunction * Poorly controlled diabetes mellitus * History or current condition of adrenal insufficiency (eg, Addison's disease) * Has received prior treatment with taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC). * Chronic steroid treatment (dose of \>10 mg daily prednisone equivalent), except for low-dose inhaled steroids (for asthma/chronic obstructive pulmonary disease), topical steroids (for mild skin conditions), or intra-articular steroid injections * Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids * Known additional malignancy that is progressing or has required active treatment within the past 3 years * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Active autoimmune disease that has required systemic treatment in the past 2 years * History of allogeneic tissue/solid organ transplant

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic neoplasm metastatic prostate carcinoma Neoplasm Metastasis Prostatic Neoplasms, Castration-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Castration-resistant prostatic cancer Metastasis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    80 sites in 19 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • A.O.U. Federico II di Napoli ( Site 0435)

    RECRUITING

    Naples, 80131, Italy

  • AOU San Luigi Gonzaga di Orbassano ( Site 0434)

    RECRUITING

    Orbassano, Torino, 10143, Italy

  • Addenbrooke's Hospital ( Site 0747)

    RECRUITING

    Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

  • Ankara Bilkent Şehir Hastanesi ( Site 0654)

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0653)

    RECRUITING

    Ankara, 06620, Turkey (Türkiye)

  • Asan Medical Center ( Site 0925)

    RECRUITING

    Songpagu, Seoul, 05505, South Korea

  • Auckland City Hospital ( Site 0831)

    RECRUITING

    Auckland, 1023, New Zealand

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 0432)

    ACTIVE_NOT_RECRUITING

    Brescia, 25123, Italy

  • BC Cancer - Vancouver Center ( Site 0103)

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Baskent University Dr. Turgut Noyan Research and Training Center ( Site 0650)

    RECRUITING

    Adana, 01250, Turkey (Türkiye)

  • Beaumont Hospital, Dublin ( Site 0465)

    RECRUITING

    Dublin, D09 V2N0, Ireland

  • Bradfordhill ( Site 0231)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0107)

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Centre Hospitalier de la Cote Basque ( Site 0496)

    RECRUITING

    Bayonne, Pyrenees-Atlantiques, 64100, France

  • Centre Oscar Lambret ( Site 0495)

    RECRUITING

    Lille, Nord, 59000, France

  • Centro de Oncología de Precisión ( Site 0241)

    RECRUITING

    Santiago, Region M. de Santiago, 7560908, Chile

  • Clinica Universidad Catolica del Maule ( Site 0236)

    RECRUITING

    Talca, Maule Region, 3465584, Chile

  • FALP ( Site 0232)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0431)

    RECRUITING

    Milan, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli ( Site 0433)

    RECRUITING

    Roma, 00168, Italy

  • Fred Hutchinson Cancer Center ( Site 0013)

    RECRUITING

    Seattle, Washington, 98109, United States

  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0200)

    RECRUITING

    La Rioja, F5300COE, Argentina

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0263)

    RECRUITING

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Hacettepe Universitesi Tip Fakultesi ( Site 0648)

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Hadassah Medical Center ( Site 0404)

    RECRUITING

    Jerusalem, 9112001, Israel

  • Hospital Alemao Oswaldo Cruz ( Site 0279)

    RECRUITING

    São Paulo, São Paulo, 01327-001, Brazil

  • Hospital Clinico San Carlos ( Site 0618)

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Moinhos de Vento ( Site 0278)

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

  • Hospital Universitario 12 de Octubre ( Site 0622)

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Ramon y Cajal ( Site 0620)

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen del Rocio ( Site 0619)

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0268)

    RECRUITING

    Bragança Paulista, São Paulo, 12916-542, Brazil

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) ( Site 0273)

    RECRUITING

    Ribeirão Preto, São Paulo, 14048900, Brazil

  • IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0269)

    RECRUITING

    São Paulo, 03102-006, Brazil

  • ICO L Hospitalet ( Site 0617)

    RECRUITING

    L Hospitalet Del Llobregat, Barcelona, 08908, Spain

  • IPITEC ( Site 0275)

    RECRUITING

    São Paulo, 01221-020, Brazil

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0498)

    RECRUITING

    Bordeaux, Gironde, 33000, France

  • Institut De Cancerologie De L Ouest ( Site 0494)

    RECRUITING

    Saint-Herblain, Pays de la Loire Region, 44800, France

  • Instituto Alexander Fleming ( Site 0202)

    RECRUITING

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0270)

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • Istanbul Universitesi Cerrahpasa ( Site 0649)

    RECRUITING

    Istanbul, 34098, Turkey (Türkiye)

  • Jewish General Hospital ( Site 0108)

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Koç Üniversitesi Hastanesi ( Site 0656)

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

  • Liga Norte Riograndense Contra o Câncer ( Site 0271)

    RECRUITING

    Natal, Rio Grande do Norte, 59062-000, Brazil

  • Macquarie University-MQ Health Clinical Trials Unit ( Site 0801)

    RECRUITING

    Macquarie University, New South Wales, 2109, Australia

  • MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026)

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Memorial Sloan Kettering Cancer Center ( Site 0006)

    RECRUITING

    New York, New York, 10065, United States

  • NCT ( Site 0528)

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0586)

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Nij Smellinghe ( Site 0684)

    RECRUITING

    Drachten, Provincie Friesland, 9202 NN, Netherlands

  • ONCOCENTRO APYS ( Site 0234)

    RECRUITING

    Viña del Mar, Valparaiso, 2520598, Chile

  • Princess Margaret Cancer Centre ( Site 0102)

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Rabin Medical Center ( Site 0402)

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus ( Site 0400)

    RECRUITING

    Haifa, 3109601, Israel

  • Recep Tayyip Erdogan University Training and Research Hospital ( Site 0655)

    RECRUITING

    Rize, 53020, Turkey (Türkiye)

  • Royal Free Hospital ( Site 0743)

    RECRUITING

    London, London, City of, NW3 2QG, United Kingdom

  • Royal Marsden Hospital (Sutton) ( Site 0741)

    RECRUITING

    London, Surrey, SM3 5PT, United Kingdom

  • Samsung Medical Center ( Site 0926)

    RECRUITING

    Seoul, 06351, South Korea

  • Severance Hospital Yonsei University Health System ( Site 0924)

    ACTIVE_NOT_RECRUITING

    Seoul, 03722, South Korea

  • Sheba Medical Center ( Site 0401)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Sourasky Medical Center ( Site 0403)

    RECRUITING

    Tel Aviv, 6423906, Israel

  • St Bartholomew's Hospital ( Site 0749)

    RECRUITING

    London, London, City of, EC1A 7BE, United Kingdom

  • St Vincent's University Hospital ( Site 0463)

    RECRUITING

    Dublin, Dublin, D04 T6F4, Ireland

  • Sunnybrook Research Institute ( Site 0109)

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Szpital Wojewódzki im. M.Kopernika Oddział Onk. Klinicznej z Pododdziałem Chemioterapii Jednodniowej ( Site 0587)

    RECRUITING

    Koszalin, West Pomeranian Voivodeship, 75-581, Poland

  • Taichung Veterans General Hospital ( Site 0902)

    RECRUITING

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital ( Site 0901)

    RECRUITING

    Taipei, 11217, Taiwan

  • Tallaght University Hospital ( Site 0462)

    RECRUITING

    Dublin, D24 NR0A, Ireland

  • The West Clinic, PLLC dba West Cancer Center ( Site 0005)

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • UCLA Hematology & Oncology ( Site 0003)

    RECRUITING

    Los Angeles, California, 90095, United States

  • UCSF Medical Center at Mission Bay ( Site 0034)

    RECRUITING

    San Francisco, California, 94158, United States

  • UMC St. Radboud ( Site 0679)

    RECRUITING

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • UPMC Hillman Cancer Center ( Site 0014)

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Universitaetsklinikum Hamburg-Eppendorf ( Site 0524)

    RECRUITING

    Hamburg, 20246, Germany

  • Universitaetsklinikum Jena ( Site 0525)

    RECRUITING

    Jena, Thuringia, 07747, Germany

  • Universitaetsklinikum Ulm. ( Site 0530)

    RECRUITING

    Ulm, Baden-Wurttemberg, 89081, Germany

  • University of California-Irvine Medical Center ( Site 0016)

    RECRUITING

    Orange, California, 92868, United States

  • University of Michigan ( Site 0021)

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0590)

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-355, Poland

  • Uniwersyteckie Centrum Kliniczne ( Site 0588)

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Ziekenhuis Gelderse Vallei ( Site 0683)

    RECRUITING

    Ede, Gelderland, 6716 RP, Netherlands

  • centre hospitalier lyon sud ( Site 0497)

    RECRUITING

    Pierre-Bénite, Rhone, 69310, France

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