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Ifinatamab deruxtecan alone or with other drugs for metastatic castration‑resistant prostate cancer

MK-2400-01A Substudy: A Phase 1/2, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)

Phase1; Phase2 Interventional Merck Sharp & Dohme LLC · NCT06863272

This trial tests whether ifinatamab deruxtecan, given alone or with other cancer drugs, helps men with metastatic castration‑resistant prostate cancer by lowering PSA and controlling disease.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment360 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionsdenosumab, chemotherapy, radiation, prednisone, ifinatamab
Locations78 sites (Los Angeles, California and 77 other locations)
Trial IDNCT06863272 on ClinicalTrials.gov

What this trial studies

This phase 1/2 study gives ifinatamab deruxtecan (I-DXd) alone or combined with agents such as docetaxel, abiraterone, enzalutamide, or MK-5684 to men with metastatic castration‑resistant prostate cancer. Phase 1 focuses on finding safe dose levels and tolerability for combination regimens, while phase 2 looks for signals of efficacy, including changes in PSA and disease control. Participants must meet criteria such as prior androgen-deprivation therapy, progression after 1–2 androgen receptor pathway inhibitors, and ECOG performance status 0–1. Safety, side effects, and anti-tumor activity are closely monitored at participating US academic centers under a master screening protocol.

Who should consider this trial

Good fit: Ideal candidates are men with metastatic castration‑resistant prostate cancer who have progressed on androgen-deprivation therapy and 1–2 prior androgen receptor pathway inhibitors, have ECOG 0–1, and can attend one of the study sites.

Not a fit: Patients with small‑cell or neuroendocrine prostate cancer, ECOG performance status above 1, uncontrolled medical conditions, or those unable to travel to the study sites are unlikely to benefit.

Why it matters

Potential benefit: If successful, it could provide a new treatment option that lowers PSA, shrinks tumors, and delays progression in men with advanced prostate cancer.

How similar studies have performed: Antibody–drug conjugates like deruxtecan have shown activity in other solid tumors, but their benefit in mCRPC is still exploratory with limited prior positive data.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Los Angeles, California and 77 other locations

+28 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Castration-Resistant Prostatic CancerMetastasis
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.