Testing ifinatamab deruxtecan alone or combined in metastatic castrate resistant prostate cancer
Tests ifinatamab deruxtecan, alone or with other drugs, in adults with advanced prostate cancer.
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- Adana, Ankara, Istanbul, and Rize, TürkiyeSee the 7 sitesAlso in 18 other countries, 76 sites
- Trial code
- NCT06863272
- EU 2024-516036-94-00
- U1111-1310-5406
- Registry title
- 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)
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 360 people, planned
- Started
- 3 Jul 2025
- Expected to end
- 1 Oct 2031
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Docetaxel
- Ifinatamab Deruxtecan
- Opevesostat
- Abiraterone
- Enzalutamide
- Rescue Medication
- Record updated
- 9 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with prostate cancer that has spread and no longer responds to hormone-lowering treatment. It tests ifinatamab deruxtecan alone or with other drugs.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Prostate cancer (adenocarcinoma, not small cell) that has spread to other parts of the body and got worse during hormone-lowering therapy (ADT) or after surgery to remove both testicles, within 6 months before screening. ECOG performance status 0 to 1.
- Earlier treatment
- Must have had 1 or 2 androgen receptor pathway inhibitors and the cancer got worse during or after them. Must have had PARP inhibitors if approved locally, or be judged unable to take them. Must not have had taxane chemotherapy for mCRPC.
Main reasons for not taking part
- History of interstitial lung disease or pneumonitis (except radiation pneumonitis that needed no steroids)
- Uncontrolled or significant heart or blood vessel disease
- History of pituitary problems or adrenal insufficiency
- Active spread to the brain or spinal fluid, or another cancer needing treatment in the past 3 years
- Prior donor tissue or solid organ transplant
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Türkiye
Also in 18 other countries, 76 sites
- Baskent University Dr. Turgut Noyan Research and Training Center (Site 0650)Adana, TürkiyeContact: Study CoordinatorTaking people
- Ankara Bilkent Şehir Hastanesi (Site 0654)Ankara, TürkiyeContact: Study CoordinatorTaking people
- Ankara Universitesi Tip Fakultesi Hastanesi (Site 0653)Ankara, TürkiyeContact: Study CoordinatorTaking people
- Hacettepe Universitesi Tip Fakultesi (Site 0648)Ankara, TürkiyeContact: Study CoordinatorTaking people
- Istanbul Universitesi Cerrahpasa (Site 0649)Istanbul, TürkiyeContact: Study CoordinatorTaking people
- Koç Üniversitesi Hastanesi (Site 0656)Istanbul, TürkiyeContact: Study CoordinatorTaking people
- Recep Tayyip Erdogan University Training and Research Hospital (Site 0655)Rize, TürkiyeContact: Study CoordinatorTaking people
About the trial
What the trial wants to find out
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
* 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.
The 4 groups in the trial
- DocetaxelExisting treatment, for comparison
Participants will receive docetaxel at a determined dose every 3 weeks (Q3W) for a maximum of 10 cycles. Each cycle is 21 days.
- Ifinatamab Deruxtecan (I-DXd)Treatment being tested
Participants will receive I-DXd at a determined dose Q3W until unacceptable toxicity, progressive disease (PD), death or withdrawal of consent.
Treatment: Ifinatamab Deruxtecan and Rescue Medication
- I-DXd + OpevesostatTreatment being tested
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 opevesostat at a determined dose until any of the criterion for discontinuation of study intervention is met.
Treatment: Ifinatamab Deruxtecan, Opevesostat, and Rescue Medication
- I-DXd +ARPI (Abiraterone or Enzalutamide)Treatment being tested
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.
Treatment: Ifinatamab Deruxtecan, Abiraterone, Enzalutamide, and Rescue Medication
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Testing ifinatamab deruxtecan alone or combined in metastatic castrate resistant prostate cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 9 October 2026