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)

NCT06863272 | Recruiting Phase 1 FDA Drug

• 5 other identifiers: 2400-01AMK-2400-01A2024-516036-94-00U1111-1310-5406IDeate-Prostate02
• Study Type: interventional
• Target: 360
• Locations: 19 countries
• Sites: 80

Brief 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.
• A safe dose level of I-DXd that can be used with other treatments.
• Participant levels of prostate specific antigen (PSA) during treatment.

Conditions

Castration-Resistant Prostatic Cancer; Metastasis

Outcome Measures

Primary Outcomes (7)

• 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.

  Up to approximately 21 days

• 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.

  Up to approximately 54 months

• 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.

  Up to approximately 24 months

• 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.

  Up to approximately 54 months

• 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.

  Up to approximately 21 days

• 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.

  Up to approximately 21 days

• 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.

  Up to approximately 21 days

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  Up to approximately 54 months

• Radiographic Progression-Free Survival (rPFS)

  Up to approximately 54 months

• Overall Survival (OS)

  Up to approximately 54 months

• Duration of Response (DOR)

  Up to approximately 54 months

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

  Up to approximately 54 months

Study Arms (4)

Docetaxel

ACTIVE COMPARATOR

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

Drug: Docetaxel

Ifinatamab Deruxtecan (I-DXd)

EXPERIMENTAL

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

Drug: Ifinatamab Deruxtecan; Drug: Rescue Medication

I-DXd + MK-5684

EXPERIMENTAL

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.

Drug: Ifinatamab Deruxtecan; Drug: MK-5684; Drug: Rescue Medication

I-DXd +ARPI (Abiraterone or Enzalutamide)

EXPERIMENTAL

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.

Drug: Ifinatamab Deruxtecan; Drug: Abiraterone; Drug: Enzalutamide; Drug: Rescue Medication

Interventions

Docetaxel DRUG

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

Docetaxel

Ifinatamab Deruxtecan DRUG

Administered via IV infusion at a specified dose on specified days

Also known as: I-DXd, MK-2400, DS-7300a

I-DXd + MK-5684; I-DXd +ARPI (Abiraterone or Enzalutamide); Ifinatamab Deruxtecan (I-DXd)

MK-5684 DRUG

Administered orally at a specified dose on specified days

Also known as: ODM-208

I-DXd + MK-5684

Abiraterone DRUG

Administered orally at a specified dose on specified days

I-DXd +ARPI (Abiraterone or Enzalutamide)

Enzalutamide DRUG

Administered orally at a specified dose on specified days

I-DXd +ARPI (Abiraterone or Enzalutamide)

Rescue Medication DRUG

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.

I-DXd + MK-5684; I-DXd +ARPI (Abiraterone or Enzalutamide); Ifinatamab Deruxtecan (I-DXd)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: collaborator
• Merck Sharp & Dohme LLC: lead

Study Sites (80)

UCLA Hematology & Oncology ( Site 0003)

Los Angeles, California, 90095, United States

RECRUITING

University of California-Irvine Medical Center ( Site 0016)

Orange, California, 92868, United States

RECRUITING

UCSF Medical Center at Mission Bay ( Site 0034)

San Francisco, California, 94158, United States

RECRUITING

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

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

RECRUITING

Memorial Sloan Kettering Cancer Center ( Site 0006)

New York, New York, 10065, United States

RECRUITING

UPMC Hillman Cancer Center ( Site 0014)

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

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

Germantown, Tennessee, 38138, United States

RECRUITING

Fred Hutchinson Cancer Center ( Site 0013)

Seattle, Washington, 98109, United States

RECRUITING

Instituto Alexander Fleming ( Site 0202)

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

RECRUITING

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

La Rioja, F5300COE, Argentina

RECRUITING

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

Macquarie University, New South Wales, 2109, Australia

RECRUITING

Liga Norte Riograndense Contra o Câncer ( Site 0271)

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

RECRUITING

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

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

RECRUITING

Hospital Moinhos de Vento ( Site 0278)

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

RECRUITING

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

Bragança Paulista, São Paulo, 12916-542, Brazil

RECRUITING

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

Ribeirão Preto, São Paulo, 14048900, Brazil

RECRUITING

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

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

RECRUITING

Hospital Alemao Oswaldo Cruz ( Site 0279)

São Paulo, São Paulo, 01327-001, Brazil

RECRUITING

IPITEC ( Site 0275)

São Paulo, 01221-020, Brazil

RECRUITING

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

São Paulo, 03102-006, Brazil

RECRUITING

BC Cancer - Vancouver Center ( Site 0103)

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Sunnybrook Research Institute ( Site 0109)

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Princess Margaret Cancer Centre ( Site 0102)

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Jewish General Hospital ( Site 0108)

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

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

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Clinica Universidad Catolica del Maule ( Site 0236)

Talca, Maule Region, 3465584, Chile

RECRUITING

FALP ( Site 0232)

Santiago, Region M. de Santiago, 7500921, Chile

RECRUITING

Centro de Oncología de Precisión ( Site 0241)

Santiago, Region M. de Santiago, 7560908, Chile

RECRUITING

Bradfordhill ( Site 0231)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

ONCOCENTRO APYS ( Site 0234)

Viña del Mar, Valparaiso, 2520598, Chile

RECRUITING

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

Bordeaux, Gironde, 33000, France

RECRUITING

Centre Oscar Lambret ( Site 0495)

Lille, Nord, 59000, France

RECRUITING

Institut De Cancerologie De L Ouest ( Site 0494)

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

RECRUITING

Centre Hospitalier de la Côte Basque ( Site 0496)

Bayonne, Pyrenees-Atlantiques, 64100, France

RECRUITING

centre hospitalier lyon sud ( Site 0497)

Pierre-Bénite, Rhone, 69310, France

RECRUITING

NCT ( Site 0528)

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Universitaetsklinikum Jena ( Site 0525)

Jena, Thuringia, 07747, Germany

RECRUITING

Universitaetsklinikum Hamburg-Eppendorf ( Site 0524)

Hamburg, 20246, Germany

RECRUITING

St Vincent's University Hospital ( Site 0463)

Dublin, Dublin, D04 T6F4, Ireland

RECRUITING

Beaumont Hospital, Dublin ( Site 0465)

Dublin, D09 V2N0, Ireland

RECRUITING

Tallaght University Hospital ( Site 0462)

Dublin, D24 NR0A, Ireland

RECRUITING

Rambam Health Care Campus ( Site 0400)

Haifa, 3109601, Israel

RECRUITING

Hadassah Medical Center ( Site 0404)

Jerusalem, 9112001, Israel

RECRUITING

Rabin Medical Center ( Site 0402)

Petah Tikva, 4941492, Israel

RECRUITING

Sheba Medical Center ( Site 0401)

Ramat Gan, 5265601, Israel

RECRUITING

Sourasky Medical Center ( Site 0403)

Tel Aviv, 6423906, Israel

RECRUITING

AOU San Luigi Gonzaga di Orbassano ( Site 0434)

Orbassano, Torino, 10143, Italy

RECRUITING

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

Brescia, 25123, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0431)

Milan, 20133, Italy

RECRUITING

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

Naples, 80131, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli ( Site 0433)

Roma, 00168, Italy

RECRUITING

Ziekenhuis Gelderse Vallei ( Site 0683)

Ede, Gelderland, 6716 RP, Netherlands

RECRUITING

UMC St. Radboud ( Site 0679)

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Nij Smellinghe ( Site 0684)

Drachten, Provincie Friesland, 9202 NN, Netherlands

RECRUITING

Auckland City Hospital ( Site 0831)

Auckland, 1023, New Zealand

RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0590)

Poznan, Greater Poland Voivodeship, 60-355, Poland

RECRUITING

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

Warsaw, Masovian Voivodeship, 02-781, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne ( Site 0588)

Gdansk, Pomeranian Voivodeship, 80-214, Poland

RECRUITING

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

Koszalin, West Pomeranian Voivodeship, 75-581, Poland

RECRUITING

Asan Medical Center ( Site 0925)

Songpagu, Seoul, 05505, South Korea

RECRUITING

Severance Hospital Yonsei University Health System ( Site 0924)

Seoul, 03722, South Korea

ACTIVE NOT RECRUITING

Samsung Medical Center ( Site 0926)

Seoul, 06351, South Korea

RECRUITING

ICO L Hospitalet ( Site 0617)

L Hospitalet Del Llobregat, Barcelona, 08908, Spain

RECRUITING

Hospital Universitario Ramon y Cajal ( Site 0620)

Madrid, 28034, Spain

RECRUITING

Hospital Clinico San Carlos ( Site 0618)

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre ( Site 0622)

Madrid, 28041, Spain

RECRUITING

Hospital Universitario Virgen del Rocio ( Site 0619)

Seville, 41013, Spain

RECRUITING

Taichung Veterans General Hospital ( Site 0902)

Taichung, 40705, Taiwan

RECRUITING

Taipei Veterans General Hospital ( Site 0901)

Taipei, 11217, Taiwan

RECRUITING

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

Adana, 01250, Turkey (Türkiye)

RECRUITING

Hacettepe Universitesi Tip Fakultesi ( Site 0648)

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0653)

Ankara, 06620, Turkey (Türkiye)

RECRUITING

Ankara Bilkent Şehir Hastanesi ( Site 0654)

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Koç Üniversitesi Hastanesi ( Site 0656)

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Istanbul Universitesi Cerrahpasa ( Site 0649)

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

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

Rize, 53020, Turkey (Türkiye)

RECRUITING

Addenbrooke's Hospital ( Site 0747)

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

RECRUITING

St Bartholomew's Hospital ( Site 0749)

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

RECRUITING

Royal Free Hospital ( Site 0743)

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

RECRUITING

Royal Marsden Hospital (Sutton) ( Site 0741)

London, Surrey, SM3 5PT, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant; Neoplasm Metastasis

Interventions

Docetaxel; abiraterone; enzalutamide

Condition Hierarchy (Ancestors)

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

AU (1); FR (5); AR (2); ES (5); IT (5); GB (4); US (8); NZ (1); PL (4); IE (3); IL (5); BR (9); NL (3); TW (2); CL (5); TU (7); CA (5); KR (3); DE (3)