Subestudio MK-2400-01A: Subestudio paraguas fase 1/2, abi... | EligiMed

Subestudio MK-2400-01A: Subestudio paraguas fase 1/2, abierto, del protocolo maestro MK-2400-U01 para evaluar la seguridad y eficacia de las combinaciones de tratamiento basadas en ifinatamab deruxtecan o ifinatamab deruxtecan en monoterapia en participantes con cáncer de próstata metastásico resistente a la castración (CPRCm) (IDeate-Prostate02)

ReclutandoFase 2ClinicalTrials.gov

ID: NCT06863272Tipo: INTERVENTIONALInicio: 3 de jul de 2025Fin estimado: 1 de abr de 2031

Resumen

El propósito de este subestudio es evaluar la eficacia y seguridad de ifinatamab deruxtecan (I-DXd), administrado solo o en combinación con otros tratamientos, en participantes con cáncer de próstata metastásico resistente a la castración (CPRCm). Los objetivos de este estudio son conocer: * La seguridad del tratamiento del estudio y si los pacientes lo toleran. * Un nivel de dosis seguro de I-DXd que pueda utilizarse en combinación con otros tratamientos. * Los niveles del antígeno prostático específico (PSA) de los participantes durante el tratamiento.

Descripción detallada

Este subestudio MK-2400-01A evalúa tratamientos para el cáncer de próstata metastásico resistente a la castración (CPRCm). El protocolo maestro de selección es MK-2400-U01.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Docetaxel

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

drug

Ifinatamab Deruxtecan

Administered via IV infusion at a specified dose on specified days

drug

MK-5684

Administered orally at a specified dose on specified days

drug

Abiraterone

Administered orally at a specified dose on specified days

drug

Enzalutamide

Administered orally at a specified dose on specified days

drug

Rescue Medication

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.

Ubicaciones

Instituto Alexander Fleming ( Site 0202)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Study Coordinator · 5411 3221 8900

RECRUITING

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

La Rioja, Argentina

Study Coordinator · 54-380-443-6443

RECRUITING

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

ColaboradorDaiichi Sankyo

Contactos

Toll Free Number

CONTACT

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

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