Testing ifinatamab deruxtecan alone or combined in metastatic castrate resistant prostate cancer

Trial details

Who runs it

Merck Sharp & Dohme LLC

Trial code

NCT06863272EU 2024-516036-94-00

Record updated

9 October 2026

Original description

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:Read full original descriptionShow less

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)

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.

Inclusion: 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.

Exclusion: Has received prior treatment with taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC); Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids; 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); 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; Known additional malignancy that is progressing or has required active treatment within the past 3 years; Active autoimmune disease that has required systemic treatment in the past 2 years; History of allogeneic tissue/solid organ transplant; The main exclusion criteria include but are not limited to the following:; Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

ClinicalTrials.gov NCT06863272 · EU CTIS 2024-516036-94-00