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)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06863272
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Castration-Resistant Prostatic Cancer
  • Metastasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    Administered via Intravenous (IV) infusion at a specified dose on specified days
  • Ifinatamab Deruxtecan — DRUG
    Administered via IV infusion at a specified dose on specified days
  • MK-5684 — DRUG
    Administered orally at a specified dose on specified days
  • Abiraterone — DRUG
    Administered orally at a specified dose on specified days
  • Enzalutamide — DRUG
    Administered orally at a specified dose on specified days
  • 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.

Study Details

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 Dates

Start date
Jul 3, 2025
Status verified
May 2026
Primary completion
Apr 1, 2031
Completion
Apr 1, 2031

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

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 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
UCLA Hematology & Oncology ( Site 0003)Los AngelesCalifornia90095
Study Coordinator
310-829-5471
University of California-Irvine Medical Center ( Site 0016)OrangeCalifornia92868
Study Coordinator
714-456-5153
UCSF Medical Center at Mission Bay ( Site 0034)San FranciscoCalifornia94158
Study Coordinator
415-502-2097
MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026)Washington D.C.District of Columbia20010
Study Coordinator
202-877-3061
Memorial Sloan Kettering Cancer Center ( Site 0006)New YorkNew York10065
Study Coordinator
347-798-8620
UPMC Hillman Cancer Center ( Site 0014)PittsburghPennsylvania15232
Study Coordinator
412-647-2811
The West Clinic, PLLC dba West Cancer Center ( Site 0005)GermantownTennessee38138
Study Coordinator
901-683-0055
Fred Hutchinson Cancer Center ( Site 0013)SeattleWashington98109
Study Coordinator
206-288-1111

Find similar trials in Los Angeles, CA

By research site
UCLA Hematology & Oncology· Los Angeles, CAUniversity of California-Irvine Medical Center· Orange, CAUCSF Medical Center at Mission Bay· San Francisco, CAMedStar Georgetown Cancer Institute at MedStar Washington Hospital Center· Washington D.C., DCMemorial Sloan Kettering Cancer Center· New York, NYUPMC Hillman Cancer Center· Pittsburgh, PA

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