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
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (4 UK sites)
Addenbrooke's Hospital ( Site 0747)
Cambridge CB2 2QQ, United Kingdom
St Bartholomew's Hospital ( Site 0749)
London EC1A 7BE, United Kingdom
Royal Free Hospital ( Site 0743)
London NW3 2QG, United Kingdom
Royal Marsden Hospital (Sutton) ( Site 0741)
London SM3 5PT, United Kingdom
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT
