MedDataX Logo

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)

NCT ID: NCT06863272

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-03

Study Completion Date

2030-02-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

The master screening protocol is MK-2400-U01.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Castration-Resistant Prostatic Cancer Metastasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Docetaxel

Participants will receive docetaxel at a determined dose every 3 weeks (Q3W) for a maximum of 10 cycles. Each cycle is 21 days.

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

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

Ifinatamab Deruxtecan (I-DXd)

Participants will receive I-DXd at a determined dose Q3W until unacceptable toxicity, progressive disease (PD), death or withdrawal of consent.

Group Type EXPERIMENTAL

Ifinatamab Deruxtecan

Intervention Type DRUG

Administered via IV infusion at a specified dose on specified days

I-DXd + MK-5684

Following 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 MK-5684 at a determined dose until any of the criterion for discontinuation of study intervention is met.

Group Type EXPERIMENTAL

Ifinatamab Deruxtecan

Intervention Type DRUG

Administered via IV infusion at a specified dose on specified days

MK-5684

Intervention Type DRUG

Administered orally at a specified dose on specified days

I-DXd +ARPI (Abiraterone or Enzalutamide)

Following 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.

Group Type EXPERIMENTAL

Ifinatamab Deruxtecan

Intervention Type DRUG

Administered via IV infusion at a specified dose on specified days

Abiraterone

Intervention Type DRUG

Administered orally at a specified dose on specified days

Enzalutamide

Intervention Type DRUG

Administered orally at a specified dose on specified days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Docetaxel

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

Intervention Type DRUG

Ifinatamab Deruxtecan

Administered via IV infusion at a specified dose on specified days

Intervention Type DRUG

MK-5684

Administered orally at a specified dose on specified days

Intervention Type DRUG

Abiraterone

Administered orally at a specified dose on specified days

Intervention Type DRUG

Enzalutamide

Administered orally at a specified dose on specified days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

I-DXd, MK-2400, DS-7300a ODM-208

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 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

* History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or has current ILD/pneumonitis or suspected ILD/pneumonitis
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Daiichi Sankyo

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

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

Site Status RECRUITING

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

Germantown, Tennessee, United States

Site Status RECRUITING

Instituto Alexander Fleming ( Site 0202)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status RECRUITING

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

La Rioja, , Argentina

Site Status RECRUITING

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

Macquarie University, New South Wales, Australia

Site Status RECRUITING

Liga Norte Riograndense Contra o Câncer ( Site 0271)

Natal, Rio Grande do Norte, Brazil

Site Status RECRUITING

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

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Hospital Moinhos de Vento ( Site 0278)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

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

Bragança Paulista, São Paulo, Brazil

Site Status RECRUITING

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

São José do Rio Preto, São Paulo, Brazil

Site Status RECRUITING

IPITEC ( Site 0275)

São Paulo, , Brazil

Site Status RECRUITING

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

São Paulo, , Brazil

Site Status RECRUITING

Clinica Universidad Catolica del Maule ( Site 0236)

Talca, Maule Region, Chile

Site Status RECRUITING

FALP ( Site 0232)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Bradfordhill ( Site 0231)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

ONCOCENTRO APYS ( Site 0234)

Viña del Mar, Región de Valparaíso, Chile

Site Status RECRUITING

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

Bordeaux, Gironde, France

Site Status RECRUITING

Centre Oscar Lambret ( Site 0495)

Lille, Nord, France

Site Status RECRUITING

Institut De Cancerologie De L Ouest ( Site 0494)

Saint-Herblain, Pays de la Loire Region, France

Site Status RECRUITING

Centre Hospitalier de la Côte Basque ( Site 0496)

Bayonne, Pyrenees-Atlantiques, France

Site Status RECRUITING

centre hospitalier lyon sud ( Site 0497)

Pierre-Bénite, Rhone, France

Site Status RECRUITING

NCT ( Site 0528)

Heidelberg, Baden-Wurttemberg, Germany

Site Status RECRUITING

Universitaetsklinikum Jena ( Site 0525)

Jena, Thuringia, Germany

Site Status RECRUITING

Universitaetsklinikum Hamburg-Eppendorf ( Site 0524)

Hamburg, , Germany

Site Status RECRUITING

Rambam Health Care Campus ( Site 0400)

Haifa, , Israel

Site Status RECRUITING

Rabin Medical Center ( Site 0402)

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center ( Site 0401)

Ramat Gan, , Israel

Site Status RECRUITING

Sourasky Medical Center ( Site 0403)

Tel Aviv, , Israel

Site Status RECRUITING

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

Naples, Napoli, Italy

Site Status RECRUITING

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

Brescia, , Italy

Site Status RECRUITING

Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0431)

Milan, , Italy

Site Status RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli ( Site 0433)

Roma, , Italy

Site Status RECRUITING

UMC St. Radboud ( Site 0679)

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

Auckland City Hospital ( Site 0831)

Auckland, , New Zealand

Site Status RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0590)

Poznan, Greater Poland Voivodeship, Poland

Site Status RECRUITING

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

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Uniwersyteckie Centrum Kliniczne ( Site 0588)

Gdansk, Pomeranian Voivodeship, Poland

Site Status RECRUITING

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

Koszalin, West Pomeranian Voivodeship, Poland

Site Status RECRUITING

Asan Medical Center ( Site 0925)

Songpagu, Seoul, South Korea

Site Status RECRUITING

Severance Hospital Yonsei University Health System ( Site 0924)

Seoul, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Samsung Medical Center ( Site 0926)

Seoul, , South Korea

Site Status RECRUITING

Hospital Universitario Ramon y Cajal ( Site 0620)

Madrid, , Spain

Site Status RECRUITING

Hospital Clinico San Carlos ( Site 0618)

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre ( Site 0622)

Madrid, , Spain

Site Status RECRUITING

Taichung Veterans General Hospital ( Site 0902)

Taichung, , Taiwan

Site Status RECRUITING

Taipei Veterans General Hospital ( Site 0901)

Taipei, , Taiwan

Site Status RECRUITING

Royal Marsden Hospital (Sutton) ( Site 0741)

London, Surrey, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Brazil Chile France Germany Israel Italy Netherlands New Zealand Poland South Korea Spain Taiwan United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MK-2400-01A

Identifier Type: OTHER

Identifier Source: secondary_id

2024-516036-94-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1310-5406

Identifier Type: REGISTRY

Identifier Source: secondary_id

IDeate-Prostate02

Identifier Type: OTHER

Identifier Source: secondary_id

2400-01A

Identifier Type: -

Identifier Source: org_study_id