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)

Recruiting now · Phase 1/Phase 2

Conditions studied: Castration-Resistant Prostatic Cancer, Metastasis

In brief

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.

Key facts

Study ID: NCT06863272
Run by: Merck Sharp & Dohme LLC
People needed: 360
Starts: 2025-07-03
Expected to finish: 2031-04-01
Last updated by the study team: 2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of California-Irvine Medical Center ( Site 0016) — Orange, California, United States (enrolling)
UCSF Medical Center at Mission Bay ( Site 0034) — San Francisco, California, United States (enrolling)
MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026) — Washington D.C., District of Columbia, United States (enrolling)
University of Michigan ( Site 0021) — Ann Arbor, Michigan, United States (enrolling)
Memorial Sloan Kettering Cancer Center ( Site 0006) — New York, New York, United States (enrolling)
UPMC Hillman Cancer Center ( Site 0014) — Pittsburgh, Pennsylvania, United States (enrolling)
The West Clinic, PLLC dba West Cancer Center ( Site 0005) — Germantown, Tennessee, United States (enrolling)
Fred Hutchinson Cancer Center ( Site 0013) — Seattle, Washington, United States (enrolling)
Instituto Alexander Fleming ( Site 0202) — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0200) — La Rioja, Argentina (enrolling)
Macquarie University-MQ Health Clinical Trials Unit ( Site 0801) — Macquarie University, New South Wales, Australia (enrolling)
Liga Norte Riograndense Contra o Câncer ( Site 0271) — Natal, Rio Grande do Norte, Brazil (enrolling)
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0270) — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
Hospital Moinhos de Vento ( Site 0278) — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0268) — Bragança Paulista, São Paulo, Brazil (enrolling)
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) ( Site 0273) — Ribeirão Preto, São Paulo, Brazil (enrolling)
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0263) — São José do Rio Preto, São Paulo, Brazil (enrolling)
Hospital Alemao Oswaldo Cruz ( Site 0279) — São Paulo, São Paulo, Brazil (enrolling)
IPITEC ( Site 0275) — São Paulo, Brazil (enrolling)
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0269) — São Paulo, Brazil (enrolling)
BC Cancer - Vancouver Center ( Site 0103) — Vancouver, British Columbia, Canada (enrolling)
Sunnybrook Research Institute ( Site 0109) — Toronto, Ontario, Canada (enrolling)
Princess Margaret Cancer Centre ( Site 0102) — Toronto, Ontario, Canada (enrolling)
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0107) — Sherbrooke, Quebec, Canada (enrolling)
UCLA Hematology & Oncology ( Site 0003) — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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