MK-2400-01A: Substudy of I-DXd-based Treatment Combinations or as Monotherapy in mCRPC
Testing I-DXd alone or in combination with other treatments 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, by itself or with other drugs, identify the best dose, and see how the cancer responds to treatment.
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
You will be randomly assigned to one of the open groups:
- Group 1: Docetaxel + prednisone/prednisolone
- Group 2: I-DXd alone
- Group 3: I-DXd + MK-5684 (extra medicines will be given to limit MK-5684 side-effects)
- Group 3: I-DXd + enzalutamide or abiraterone + 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 an 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 the study.
- 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 or current interstitial-lung disease (ILD) / pneumonitis that needed steroids.
- Severe lung problems, uncontrolled heart disease, pituitary-gland trouble, poorly controlled diabetes, or adrenal insufficiency
- Prior 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 has been 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.
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 (IV or pills).
- Trial Visits: Physical exams, blood and urine tests, side-effect checks.
- Imaging Scans: CT/MRI, bone scans, and brain scans (if prior history of brain metastases) 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.
- PARP Inhibitor: A drug that blocks DNA repair in cancer cells.
- Bone-Resorptive Therapy: Medicines, such as bisphosphonates or denosumab, that protect bones.
- ECOG 0–1: 0 = fully active; 1 = can do light work.
- Docetaxel / Abiraterone / Enzalutamide / MK-5684: Standard or investigational drugs used with I-DXd in this study.
- ILD: Scarring or inflammation of the lungs that can make breathing difficult.
Organization:
Merck Sharpe & Dohme LLC
Clinicaltrials.gov Information:
- NCT Number: NCT06863272
- 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)
Use the “clinical trials glossary” and “dictionary” for words, phrases, and treatments that you may not understand.
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Please note: This information is provided for educational and awareness purposes. A decision on clinical trial participation is to be made between the patient and his doctor.
