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AzTrials

Castration-Resistant Prostatic CancerPhase 1/2NCT06863272

A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02)

A Phase 1/2 study testing Docetaxel, Ifinatamab Deruxtecan and Opevesostat in people with Castration-Resistant Prostatic Cancer and Metastasis, run by Merck Sharp & Dohme LLC at 82 sites in 19 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this substudy is to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd), given alone or with other treatments in participants with metastatic castration-resistant prostate cancer (mCRPC). The goals of this study are to learn about: The safety of the study treatment and if people tolerate it. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Docetaxel, Ifinatamab Deruxtecan and Opevesostat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
82 sitesin 19 countries
Study dates
3 Jul 2025to 1 Oct 2031
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

82 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

82 sites in 19 countries

United States9 sites, 9 recruiting

  • University of Michigan ( Site 0021)

    Ann Arbor, Michigan, 48109

    Study Coordinator, 734-936-4000

    Recruiting

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

    Germantown, Tennessee, 38138

    Study Coordinator, 901-683-0055

    Recruiting

  • UCLA Hematology & Oncology ( Site 0003)

    Los Angeles, California, 90095

    Study Coordinator, 310-829-5471

    Recruiting

  • Memorial Sloan Kettering Cancer Center ( Site 0006)

    New York, New York, 10065

    Study Coordinator, 347-798-8620

    Recruiting

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

    Orange, California, 92868

    Study Coordinator, 714-456-5153

    Recruiting

  • UPMC Hillman Cancer Center ( Site 0014)

    Pittsburgh, Pennsylvania, 15232

    Study Coordinator, 412-647-2811

    Recruiting

  • UCSF Medical Center at Mission Bay ( Site 0034)

    San Francisco, California, 94158

    Study Coordinator, 415-502-2097

    Recruiting

  • Fred Hutchinson Cancer Center ( Site 0013)

    Seattle, Washington, 98109

    Study Coordinator, 206-288-1111

    Recruiting

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

    Washington D.C., District of Columbia, 20010

    Study Coordinator, 202-877-3061

    Recruiting

Other trials in United States

Brazil9 sites, 9 recruiting

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

    Bragança Paulista, São Paulo, 12916-542

    Study Coordinator, +551124901366

    Recruiting

  • Liga Norte Riograndense Contra o Câncer ( Site 0271)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, (84) 4009-5595

    Recruiting

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

    Porto Alegre, Rio Grande do Sul, 90020-090

    Study Coordinator, +555132148151

    Recruiting

  • Hospital Moinhos de Vento ( Site 0278)

    Porto Alegre, Rio Grande do Sul, 90035-001

    Study Coordinator, +55 51 3314-3209

    Recruiting

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

    Ribeirão Preto, São Paulo, 14048900

    Study Coordinator, (16) 3963-6487

    Recruiting

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

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

    Study Coordinator, +55 17 99625-3919

    Recruiting

  • Hospital Alemao Oswaldo Cruz ( Site 0279)

    São Paulo, São Paulo, 01327-001

    Study Coordinator, 55 11 3549-0009

    Recruiting

  • IPITEC ( Site 0275)

    São Paulo, 01221-020

    Study Coordinator, +551194322-6006

    Recruiting

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

    São Paulo, 03102-006

    Study Coordinator, +551144500360

    Recruiting

Other trials in Brazil

Turkey (Türkiye)7 sites, 7 recruiting

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

    Adana, 01250

    Study Coordinator, +903223271274

    Recruiting

  • Hacettepe Universitesi Tip Fakultesi ( Site 0648)

    Ankara, 06230

    Study Coordinator, +90 312 305 50 00

    Recruiting

  • Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0653)

    Ankara, 06620

    Study Coordinator, +903122126040

    Recruiting

  • Ankara Bilkent Şehir Hastanesi ( Site 0654)

    Ankara, 06800

    Study Coordinator, +903125526000

    Recruiting

  • Koç Üniversitesi Hastanesi ( Site 0656)

    Istanbul, 34010

    Study Coordinator, +905369410661

    Recruiting

  • Istanbul Universitesi Cerrahpasa ( Site 0649)

    Istanbul, 34098

    Study Coordinator, +902124143000

    Recruiting

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

    Rize, 53020

    Study Coordinator, +904642130491

    Recruiting

Other trials in Turkey (Türkiye)

Canada5 sites, 5 recruiting

  • Jewish General Hospital ( Site 0108)

    Montreal, Quebec, H3T 1E2

    Study Coordinator, 5143408110

    Recruiting

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

    Sherbrooke, Quebec, J1H 5N4

    Study Coordinator, 8197802222

    Recruiting

  • Sunnybrook Research Institute ( Site 0109)

    Toronto, Ontario, M4N 3M5

    Study Coordinator, 4164806100

    Recruiting

  • Princess Margaret Cancer Centre ( Site 0102)

    Toronto, Ontario, M5G 2M9

    Study Coordinator, 4169464501

    Recruiting

  • BC Cancer - Vancouver Center ( Site 0103)

    Vancouver, British Columbia, V5Z 4E6

    Study Coordinator, 6048776000

    Recruiting

Other trials in Canada

Chile5 sites, 5 recruiting

  • Fundación Arturo López Pérez ( Site 0232)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, 56224205098

    Recruiting

  • Centro de Oncología de Precisión ( Site 0241)

    Santiago, Region M. de Santiago, 7560908

    Study Coordinator, +56225189885

    Recruiting

  • Bradfordhill ( Site 0231)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +56229490970

    Recruiting

  • Clinica Universidad Catolica del Maule ( Site 0236)

    Talca, Maule Region, 3465584

    Study Coordinator, 56992992913

    Recruiting

  • ONCOCENTRO APYS ( Site 0234)

    Viña del Mar, Valparaiso, 2520598

    Study Coordinator, +56323320850

    Recruiting

Other trials in Chile

France5 sites, 5 recruiting

  • Centre Hospitalier de la Cote Basque ( Site 0496)

    Bayonne, Pyrenees-Atlantiques, 64100

    Study Coordinator, +33559443762

    Recruiting

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

    Bordeaux, Gironde, 33000

    Study Coordinator, +33556333261

    Recruiting

  • Centre Oscar Lambret ( Site 0495)

    Lille, Nord, 59000

    Study Coordinator, +333 20 29 56 06

    Recruiting

  • centre hospitalier lyon sud ( Site 0497)

    Pierre-Bénite, Rhone, 69310

    Study Coordinator, 33 4 78 86 43 24

    Recruiting

  • Institut De Cancerologie De L Ouest ( Site 0494)

    Saint-Herblain, Pays de la Loire Region, 44800

    Study Coordinator, +33240679900

    Recruiting

Other trials in France

Israel5 sites, 5 recruiting

  • Rambam Health Care Campus ( Site 0400)

    Haifa, 3109601

    Study Coordinator, 972(47776234)

    Recruiting

  • Hadassah Medical Center ( Site 0404)

    Jerusalem, 9112001

    Study Coordinator, +97226777333

    Recruiting

  • Rabin Medical Center ( Site 0402)

    Petah Tikva, 4941492

    Study Coordinator, +972544594048

    Recruiting

  • Sheba Medical Center ( Site 0401)

    Ramat Gan, 5265601

    Study Coordinator, +97235303030

    Recruiting

  • Sourasky Medical Center ( Site 0403)

    Tel Aviv, 6423906

    Study Coordinator, +97236947832

    Recruiting

Other trials in Israel

Italy5 sites, 4 recruiting

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

    Brescia, 25123

    Active, not recruiting

  • Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0431)

    Milan, 20133

    Study Coordinator, +390223904449

    Recruiting

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

    Naples, 80131

    Study Coordinator, +390817463660

    Recruiting

  • AOU San Luigi Gonzaga di Orbassano ( Site 0434)

    Orbassano, Torino, 10143

    Study Coordinator, 00390119026534

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli ( Site 0433)

    Roma, 00168

    Study Coordinator, +390630155202

    Recruiting

Other trials in Italy

Spain5 sites, 5 recruiting

  • ICO L Hospitalet ( Site 0617)

    L Hospitalet Del Llobregat, Barcelona, 08908

    Study Coordinator, +34932607744

    Recruiting

  • Hospital Universitario Ramon y Cajal ( Site 0620)

    Madrid, 28034

    Study Coordinator, +34913368263

    Recruiting

  • Hospital Clinico San Carlos ( Site 0618)

    Madrid, 28040

    Study Coordinator, +34913303546

    Recruiting

  • Hospital Universitario 12 de Octubre ( Site 0622)

    Madrid, 28041

    Study Coordinator, +34608464547

    Recruiting

  • Hospital Universitario Virgen del Rocio ( Site 0619)

    Seville, 41013

    Study Coordinator, +34955013068

    Recruiting

Other trials in Spain

Germany4 sites, 4 recruiting

  • Universitaetsklinikum Hamburg-Eppendorf ( Site 0524)

    Hamburg, 20246

    Study Coordinator, +4915222815585

    Recruiting

  • NCT ( Site 0528)

    Heidelberg, Baden-Wurttemberg, 69120

    Study Coordinator, 00496221566857

    Recruiting

  • Universitaetsklinikum Jena ( Site 0525)

    Jena, Thuringia, 07747

    Study Coordinator, +49-3641-9-329901

    Recruiting

  • Universitaetsklinikum Ulm. ( Site 0530)

    Ulm, Baden-Wurttemberg, 89081

    Study Coordinator, +4973150058188

    Recruiting

Other trials in Germany

Poland4 sites, 4 recruiting

  • Uniwersyteckie Centrum Kliniczne ( Site 0588)

    Gdansk, Pomeranian Voivodeship, 80-214

    Study Coordinator, +48 58 584 44 66

    Recruiting

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

    Koszalin, West Pomeranian Voivodeship, 75-581

    Study Coordinator, +48943488930

    Recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0590)

    Poznan, Greater Poland Voivodeship, 60-355

    Study Coordinator, +61 854 79 87

    Recruiting

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

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, +48 22 546 33 81

    Recruiting

Other trials in Poland

United Kingdom4 sites, 4 recruiting

  • Addenbrooke's Hospital ( Site 0747)

    Cambridge, Cambridgeshire, CB2 2QQ

    Study Coordinator, 00441223216083

    Recruiting

  • St Bartholomew's Hospital ( Site 0749)

    London, London, City of, EC1A 7BE

    Study Coordinator, 00442073777000

    Recruiting

  • Royal Free Hospital ( Site 0743)

    London, London, City of, NW3 2QG

    Study Coordinator, 00442077940500/2237

    Recruiting

  • Royal Marsden Hospital (Sutton) ( Site 0741)

    London, Surrey, SM3 5PT

    Study Coordinator, 0203 437 3500

    Recruiting

Other trials in United Kingdom

Ireland3 sites, 3 recruiting

  • St Vincent's University Hospital ( Site 0463)

    Dublin, Dublin, D04 T6F4

    Study Coordinator, +353 1 221 4982

    Recruiting

  • Beaumont Hospital, Dublin ( Site 0465)

    Dublin, D09 V2N0

    Study Coordinator, 0035318092010

    Recruiting

  • Tallaght University Hospital ( Site 0462)

    Dublin, D24 NR0A

    Study Coordinator, 0035314144209

    Recruiting

Other trials in Ireland

Netherlands3 sites, 3 recruiting

  • Nij Smellinghe ( Site 0684)

    Drachten, Provincie Friesland, 9202 NN

    Study Coordinator, 0512 588 888

    Recruiting

  • Ziekenhuis Gelderse Vallei ( Site 0683)

    Ede, Gelderland, 6716 RP

    Study Coordinator, +31 318 435499

    Recruiting

  • UMC St. Radboud ( Site 0679)

    Nijmegen, Gelderland, 6525 GA

    Study Coordinator, +31 24 361 1111

    Recruiting

Other trials in Netherlands

South Korea3 sites, 2 recruiting

  • Severance Hospital Yonsei University Health System ( Site 0924)

    Seoul, 03722

    Active, not recruiting

  • Samsung Medical Center ( Site 0926)

    Seoul, 06351

    Study Coordinator, +82234103459

    Recruiting

  • Asan Medical Center ( Site 0925)

    Songpagu, Seoul, 05505

    Study Coordinator, +82230105977

    Recruiting

Other trials in South Korea

Argentina2 sites, 2 recruiting

  • Instituto Alexander Fleming ( Site 0202)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ

    Study Coordinator, 5411 3221 8900

    Recruiting

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

    La Rioja, F5300COE

    Study Coordinator, 54-380-443-6443

    Recruiting

Other trials in Argentina

Taiwan2 sites, 2 recruiting

  • Taichung Veterans General Hospital ( Site 0902)

    Taichung, 40705

    Study Coordinator, +886423592525

    Recruiting

  • Taipei Veterans General Hospital ( Site 0901)

    Taipei, 11217

    Study Coordinator, +886228712121

    Recruiting

Other trials in Taiwan

Australia1 site, 1 recruiting

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

    Macquarie University, New South Wales, 2109

    Study Coordinator, +61 2 9812 2956

    Recruiting

Other trials in Australia

New Zealand1 site, 1 recruiting

  • Auckland City Hospital ( Site 0831)

    Auckland, 1023

    Study Coordinator, +6493074949

    Recruiting

Other trials in New Zealand

About this study

Official title: MK-2400-01A Substudy: A Phase 1/2, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)

The purpose of this substudy is to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd), given alone or with other treatments in participants with metastatic castration-resistant prostate cancer (mCRPC). The goals of this study are to learn about:

  • The safety of the study treatment and if people tolerate it.
  • A safe dose level of I-DXd that can be used with other treatments.
  • Participant levels of prostate specific antigen (PSA) during treatment.
Read the detailed description

This sub study MK-2400-01A assesses treatments for metastatic castration-resistant prostate cancer (mCRPC).

The master screening protocol is MK-2400-U01

Being tested
Docetaxel, Ifinatamab Deruxtecan, Opevesostat, Abiraterone, Enzalutamide
Medical subject headings
Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Administered via Intravenous (IV) infusion at a specified dose on specified days

  • Ifinatamab DeruxtecanDrug

    Also called I-DXd, MK-2400, DS-7300a

    Administered via IV infusion at a specified dose on specified days

  • OpevesostatDrug

    Also called MK-5684, ODM-208

    Administered orally at a specified dose on specified days

  • AbirateroneDrug

    Administered orally at a specified dose on specified days

  • EnzalutamideDrug

    Administered orally at a specified dose on specified days

  • Rescue MedicationDrug

    Before each dose of I-DXd, participants are required to take premedication for prevention of nausea and vomiting with a 2- or 3-drug combination regimen (eg, dexamethasone with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist as well as other drugs as indicated) per approved product label.

Study groups in NCT06863272
Study groupRoleWhat they receive
DocetaxelActive comparatorParticipants will receive docetaxel at a determined dose every 3 weeks (Q3W) for a maximum of 10 cycles. Each cycle is 21 days.
Receives: Drug: Docetaxel
Ifinatamab Deruxtecan (I-DXd)ExperimentalParticipants will receive I-DXd at a determined dose Q3W until unacceptable toxicity, progressive disease (PD), death or withdrawal of consent.
Receives: Drug: Ifinatamab Deruxtecan; Drug: Rescue Medication
I-DXd + OpevesostatExperimentalFollowing a dose escalation regimen with I-DXd, participants will receive I-DXd at a determined dose until unacceptable toxicity, PD, death or withdrawal of consent PLUS opevesostat at a determined dose until any of the criterion for discontinuation of study intervention is met.
Receives: Drug: Ifinatamab Deruxtecan; Drug: Opevesostat; Drug: Rescue Medication
I-DXd +ARPI (Abiraterone or Enzalutamide)ExperimentalFollowing a dose escalation regimen with I-DXd, participants will receive I-DXd at a determined dose until unacceptable toxicity, PD, death or withdrawal of consent PLUS ARPI (Androgen Receptor Pathway Inhibitor) - Abiraterone acetate OR Enzalutamide at a determined dose until any of the criterion for discontinuation of study intervention is met.
Receives: Drug: Ifinatamab Deruxtecan; Drug: Abiraterone; Drug: Enzalutamide; Drug: Rescue Medication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms Only

    The following events if considered drug related by the Investigator, will be considered a DLT: Grade 4 nonhematologic toxicity (not based on laboratory value); Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia associated with clinically significant bleeding; Nonhematologic AEs ≥Grade 3 with exceptions; Grade 3 or Grade 4 non-hematologic laboratory values if requires medical intervention, leads to hospitalization, persists for >1 week, or results in a Drug-induced Liver Injury with exceptions; Grade 3 or 4 febrile neutropenia; Study intervention - related toxicities that lead to discontinuation of study treatment during Cycle 1; Prolonged delay (>2 weeks) in initiating Cycles 2 due to treatment-related toxicity; Missing >25% of study intervention doses as a result of treatment-related AE during Cycle 1; Grade 5 toxicity.

    Measured: Up to approximately 21 days

  2. Efficacy Phase: Number of Participants Who Experienced an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 54 months

  3. Efficacy Phase: Number of Participants Who Discontinued Study Intervention Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 24 months

  4. Efficacy Phase: Prostate-Specific Antigen (PSA) response rate

    PSA response is defined per prostate cancer working group (PCWG) criteria as a reduction in the PSA level of 50% or more from baseline measured at consecutive assessments at least 3 weeks apart.

    Measured: Up to approximately 54 months

  5. Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms Only

    The following events if considered drug related by the Investigator, will be considered a DLT: Grade 4 nonhematologic toxicity (not based on laboratory value); Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia associated with clinically significant bleeding; Nonhematologic AEs ≥Grade 3 with exceptions; Grade 3 or Grade 4 non-hematologic laboratory values if requires medical intervention, leads to hospitalization, persists for >1 week, or results in a Drug-induced Liver Injury with exceptions; Grade 3 or 4 febrile neutropenia; Study intervention - related toxicities that lead to discontinuation of study treatment during Cycle 1; Prolonged delay (>2 weeks) in initiating Cycles 2 due to treatment-related toxicity; Missing >25% of study intervention doses as a result of treatment-related AE during Cycle 1; Grade 5 toxicity.

    Measured: Up to approximately 21 days

  6. Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE) - Combination Arms Only

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 21 days

  7. Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE - Combination Arms Only

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 21 days

Secondary outcomes (7)

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per PCWG3-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

    Measured: Up to approximately 54 months

  2. Radiographic Progression-Free Survival (rPFS)

    rPFS is defined as the time from randomization to the first documented progressive disease (PD) per PCWG3-modified RECIST 1.1 based on BICR or death due to any cause, whichever occurred first. Per PCWG3-modified RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions or ≥2 new bone lesions was also considered PD. PCWG3-modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1 and PCWG3 rules include new bone lesions. The rPFS per PCWG3-modified RECIST as assessed by BICR for all participants is presented. The nonparametric Kaplan-Meier method will be used to estimate the rPFS curve in each treatment arm

    Measured: Up to approximately 54 months

  3. Overall Survival (OS)

    Overall survival (OS) is defined as the time from randomization to death due to any cause. The nonparametric Kaplan-Meier method will be used to estimate the survival curves.

    Measured: Up to approximately 54 months

  4. Duration of Response (DOR)

    DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per PCWG3-modified RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of ≥ 2 new bone lesions is also considered PD. DOR as assessed by BICR is presented. The nonparametric Kaplan-Meier method will be used to estimate the DOR in each treatment arm.

    Measured: Up to approximately 54 months

  5. Time from allocation/randomization to initiation of the first subsequent anticancer therapy (TFST)

    TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first. The nonparametric Kaplan-Meier method will be used to estimate the TFST in each treatment arm.

    Measured: Up to approximately 54 months

  6. Time to Prostate-Specific Antigen (PSA) Progression

    Time to PSA progression is defined as the time from randomization to PSA progression. Participants without PSA progression will be censored at the last PSA assessment date. The PSA progression date is defined as the date of:

    1. ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there is PSA decline from baseline, OR 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline.

    Measured: Up to approximately 54 months

  7. Time to pain progression (TTPP)

    The time from allocation/randomization to pain progression based on the Brief Pain Inventory-Short Form (BPI-SF) Item 3 "worst pain in 24 hours" and by the Analgesic Quantification Algorithm (AQA) score.

    Measured: Up to approximately 54 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2025
  2. Study start3 Jul 2025
  3. Primary completion1 Oct 2031 (estimated)
  4. Study completion1 Oct 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06863272
Sponsor's protocol ID
2400-01A
Other IDs
MK-2400-01A, 2024-516036-94-00, U1111-1310-5406, IDeate-Prostate02
Status last verified
Oct 2026
First submitted
3 Mar 2025
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Docetaxel, Ifinatamab Deruxtecan and Opevesostat in people with Castration-Resistant Prostatic Cancer and Metastasis, run by Merck Sharp & Dohme LLC at 82 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Brazil, Turkey (Türkiye), Canada, Chile and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms Only (time frame: Up to approximately 21 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06863272.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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