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A Study of Ifinatamab Deruxtecan for Metastatic Castration-Resistant Prostate Cancer

This study is looking at a new treatment called Ifinatamab Deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This is prostate cancer that has spread and no longer responds to hormone therapy. Researchers want to see how safe I-DXd is, if people can tolerate it, and if it works to shrink tumors or slow their growth. I-DXd will be given alone or in combination with other common prostate cancer treatments like Docetaxel, MK-5684, Abiraterone, or Enzalutamide. You might be able to join if you have prostate cancer that has spread and progressed despite hormone therapy.

Study design
This is an interventional study planning to enroll 360 participants. It will test different combinations of treatments or I-DXd alone.
What's involved
The study will track side effects for up to 54 months and how many participants stop treatment due to side effects for up to 24 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects for up to approximately 54 months after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~360 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:DocetaxelIfinatamab DeruxtecanOpevesostatAbirateroneEnzalutamideRescue Medication

At a glance

Recruiting sites
81 of 82 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms Only
Measured over Up to approximately 21 days
+6 more outcomes measured

Conditions

Castration-Resistant Prostatic Cancer
Metastasis

Explore related trials

Prostate Carcinoma

Where it's being run

82 sites across 49 states
Turkey (Türkiye)7
Israel5
São Paulo4
Italy4
Spain4
California3
Region M. de Santiago3
Rio Grande do Sul2

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Efficacy Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms OnlyUp to approximately 21 days

    The following events if considered drug related by the Investigator, will be considered a DLT: Grade 4 nonhematologic toxicity (not based on laboratory value); Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia associated with clinically significant bleeding; Nonhematologic AEs ≥Grade 3 with exceptions; Grade 3 or Grade 4 non-hematologic laboratory values if requires medical intervention, leads to hospitalization, persists for \>1 week, or results in a Drug-induced Liver Injury with exceptions; Grade 3 or 4 febrile neutropenia; Study intervention - related toxicities that lead to discontinuation of study treatment during Cycle 1; Prolonged delay (\>2 weeks) in initiating Cycles 2 due to treatment-related toxicity; Missing \>25% of study intervention doses as a result of treatment-related AE during Cycle 1; Grade 5 toxicity.

  • Efficacy Phase: Number of Participants Who Experienced an Adverse Event (AE)Up to approximately 54 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  • Efficacy Phase: Number of Participants Who Discontinued Study Intervention Due to an AEUp to approximately 24 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  • Efficacy Phase: Prostate-Specific Antigen (PSA) response rateUp to approximately 54 months

    PSA response is defined per prostate cancer working group (PCWG) criteria as a reduction in the PSA level of 50% or more from baseline measured at consecutive assessments at least 3 weeks apart.

  • Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms OnlyUp to approximately 21 days

    The following events if considered drug related by the Investigator, will be considered a DLT: Grade 4 nonhematologic toxicity (not based on laboratory value); Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia associated with clinically significant bleeding; Nonhematologic AEs ≥Grade 3 with exceptions; Grade 3 or Grade 4 non-hematologic laboratory values if requires medical intervention, leads to hospitalization, persists for \>1 week, or results in a Drug-induced Liver Injury with exceptions; Grade 3 or 4 febrile neutropenia; Study intervention - related toxicities that lead to discontinuation of study treatment during Cycle 1; Prolonged delay (\>2 weeks) in initiating Cycles 2 due to treatment-related toxicity; Missing \>25% of study intervention doses as a result of treatment-related AE during Cycle 1; Grade 5 toxicity.

  • Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE) - Combination Arms OnlyUp to approximately 21 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  • Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE - Combination Arms OnlyUp to approximately 21 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.