Phase 3 Study of I-DXd Versus Docetaxel in mCRPC (MK-2400-001/IDeate-Prostate01)
Testing I-DXd alone versus docetaxel for people with metastatic castration-resistant prostate cancer (mCRPC)
About This Study
Metastatic castration-resistant prostate cancer is a cancer that has spread and no longer responds to hormone-lowering treatment. There is currently no cure, and more research is needed.
Study Purpose
Researchers seek to learn how safe I-DXd is and see how well it works compared to docetaxel, which is a standard treatment for mCRPC.
About the Investigational Drug (I-DXd, MK-2400)
I-DXd is an investigational antibody-drug conjugate (ADC). It attaches to a protein called B7-H3 found on many prostate-cancer cells, moves inside, and then releases the investigational anti-cancer drug that may kill cancer cells.
Treatment Groups
Approximately 1,400 participants worldwide will be randomly assigned (like flipping a coin) to receive either I-DXd alone or docetaxel.
- Group 1: I-DXd alone
- Group 2: Docetaxel + prednisone/prednisolone
Who Can Join
Key Inclusion Criteria
- Adenocarcinoma of the prostate without small-cell features and with metastases on scans.
- Able to provide tumor tissue from a newly obtained soft-tissue sample and/or archival soft-tissue sample.
- mCRPC that got worse on androgen-deprivation therapy (ADT) within the last 6 months.
- One or two prior androgen-receptor pathway inhibitors (ARPIs) for at least 8 weeks with proof of progression.
- ECOG 0–1 (fully active or able to do light work).
- If taking bone-strengthening drugs (bisphosphonate or denosumab), you must be on a stable dose for ≥ 4 weeks before joining.
- Prior PARP-inhibitor treatment is allowed if your doctor thought it appropriate for you. If you are ineligible for it, you can also participate.
Who Cannot Join
Key Exclusion Criteria
- Past non-infectious interstitial lung disease (ILD) or pneumonitis that needed steroids.
- Severe lung problems or uncontrolled serious heart disease.
- Previous taxane chemotherapy (such as docetaxel) for mCRPC.
- Ongoing steroid treatment (> 10 mg prednisone daily), excluding treatment for asthma/COPD, mild skin conditions or joint injections.
- Radiotherapy within 2 weeks before study treatment or radiation side-effects needing steroids.
- Another active cancer that is progressing or required active treatment in the last 3 years.
- Untreated brain metastases, active autoimmune disease needing treatment in the past 2 years, or prior organ transplant.
- The cancer is active and ongoing in the brain or spinal cord, or in the protective layers surrounding them.
What to Expect
Steps and What Happens:
- Screening: Provide a tumor sample, physical exams, blood and urine tests and imaging scans, to confirm eligibility.
- Treatment: Receive the drugs for your group.
- Trial Visits: Physical exams, blood and urine tests, side-effect checks.
- Imaging Scans: CT/MRI and bone scans to track cancer.
Key Terms Explained
- mCRPC: Prostate cancer that has spread and no longer responds to standard hormone treatment.
- ADT: Therapy that lowers male hormones (androgens) to slow prostate cancer growth.
- ARPI: A pill that blocks the androgen-receptor pathway, further limiting cancer growth.
- ADC: A lab-made antibody linked to a chemotherapy drug that targets cancer cells.
- B7-H3: A protein found on many prostate-cancer cells; I-DXd uses it as a docking site.
- OS (Overall Survival): The length of time patients stay alive after starting treatment.
- PFS (Progression-Free Survival): How long patients live without their cancer getting worse.
- Docetaxel: A standard chemotherapy drug already used for advanced prostate cancer.
- Random Assignment: A process that puts participants into study groups by chance, not choice.
- ILD: Scarring or inflammation of the lungs that can make breathing difficult.
Organization:
Merck Sharpe & Dohme LLC
Clinicaltrials.gov Information:
- NCT Number: NCT06925737
- Title: A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
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Please Note: This information is provided for educational and awareness purposes. A decision on clinical trials participation is to be made between the patient and his doctor.
