NCT06863272 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 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Castration-Resistant Prostatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2025-07-03 |
| Primary Completion | 2031-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 360 participants in total. It began in 2025-07-03 with a primary completion date of 2031-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 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 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: The main exclusion criteria include but are not limited to the following: * 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
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT06863272 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Castration-Resistant Prostatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06863272 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06863272 currently recruiting?
Yes, NCT06863272 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT06863272 trial being conducted?
This trial is being conducted at Los Angeles, United States, Orange, United States, San Francisco, United States, Washington D.C., United States and 11 additional locations.
Who is sponsoring the NCT06863272 clinical trial?
NCT06863272 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 360 participants.
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