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Looking for participantsPhase1/Phase2

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)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06863272

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Docetaxel (drug), Ifinatamab Deruxtecan (drug), Opevesostat (drug), Abiraterone (drug)
How long the study runs
Study runs about 75 months (dates as stated)
About the drug or intervention
Docetaxel — drug: Administered via Intravenous (IV) infusion at a specified dose on specified days · Ifinatamab Deruxtecan — drug: Administered via IV infusion at a specified dose on specified days · Opevesostat — drug: Administered orally at a specified dose on specified days · Abiraterone — drug: Administered orally at a specified dose on specified days · Enzalutamide — drug: Administered orally at a specified dose on specified days · Rescue Medication — drug: Before each dose of I-DXd, participants are required to take premedication for prevention of nausea and vomiting with a 2- or 3-drug combination regimen (eg, dexamethasone with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist as well as other drugs as indicated) per approved product label.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
360
Started
2025-07-03
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for castration-resistant prostatic cancer
  • • Phase1/Phase2 - 360 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with castration-resistant prostatic cancer

Where?

  • • Cambridge - Addenbrooke's Hospital ( Site 0747)
  • • London - St Bartholomew's Hospital ( Site 0749)
  • • London - Royal Free Hospital ( Site 0743)
  • • London - Royal Marsden Hospital (Sutton) ( Site 0741)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This sub study MK-2400-01A assesses treatments for metastatic castration-resistant prostate cancer (mCRPC). The master screening protocol is MK-2400-U01

Castration-Resistant Prostatic CancerMetastasis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ been on stable doses for ≥4 weeks
  • ✓ poly-ADP-ribose polymerase inhibit

What the study is looking for

  • ✓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...
  • ✓Has current evidence of distant that has spread disease
  • ✓Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after...

Who cannot take part

  • ✗The main exclusion criteria include but are not limited to the following:
  • ✗Clinically severe lung compromise resulting from intercurrent lung illnesses
  • ✗Uncontrolled or significant cardiovascular disease
  • ✗History of pituitary dysfunction
  • ✗Poorly controlled diabetes mellitus
See the full 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 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 Criteria: The main exclusion criteria include but are not limited to the following: * 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

Where Is This Study? (4 UK sites)

Addenbrooke's Hospital ( Site 0747)

Cambridge CB2 2QQ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator00441223216083

St Bartholomew's Hospital ( Site 0749)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator00442073777000

Royal Free Hospital ( Site 0743)

London NW3 2QG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator00442077940500/2237

Royal Marsden Hospital (Sutton) ( Site 0741)

London SM3 5PT, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0203 437 3500

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10