Study on Ifinatamab Deruxtecan for Treating Advanced Prostate Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06863272
This clinical trial is testing a new treatment, Ifinatamab Deruxtecan, either alone or with other medications, to see if it is safe and effective for men with advanced prostate cancer that has spread and is resistant to hormone therapy.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to evaluate the safety and effectiveness of Ifinatamab Deruxtecan (I-DXd) in men with metastatic castration-resistant prostate cancer (mCRPC). The study aims to determine if the treatment is safe, how well patients tolerate it, and the appropriate dose when used with other treatments. Researchers will also monitor levels of prostate-specific antigen (PSA) during the treatment to assess its impact on the cancer.
Description
This study, known as MK-2400-01A, is focused on finding effective treatments for men with metastatic castration-resistant prostate cancer (mCRPC). The study is part of a larger screening protocol called MK-2400-U01. Participants will receive Ifinatamab Deruxtecan, either by itself or in combination with other treatments, to see if it can help control their cancer. The study will closely monitor participants for any side effects and measure their PSA levels to evaluate the treatment's effectiveness.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with prostate cancer that has spread and is resistant to hormone therapy.
- Cancer must have progressed while on hormone therapy or after surgical removal of the testicles within the last 6 months.
- Evidence of cancer spread to other parts of the body.
- Previously treated with 1 or 2 medications that target androgen receptors and experienced cancer progression during or after treatment.
- If receiving bone-strengthening therapy, must have been on a stable dose for at least 4 weeks before starting the study.
- Good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Previously treated with PARP inhibitors if recommended or deemed ineligible by the doctor.
Exclusion Criteria
- History of lung disease or inflammation that required steroids, or current lung issues.
- Severe lung problems due to other illnesses.
- Uncontrolled or serious heart disease.
- History of pituitary gland problems.
- Poorly managed diabetes.
- History or current condition of adrenal gland problems like Addison's disease.
- Previously treated with taxane-based chemotherapy for advanced prostate cancer.
- Long-term steroid use, except for low-dose inhaled or topical steroids.
- Recent radiation therapy within 2 weeks before starting the study or ongoing side effects from radiation.
- Other active cancers that have required treatment in the last 3 years.
- Active cancer spread to the brain or spinal cord.
- Active autoimmune disease needing treatment in the last 2 years.
- History of organ or tissue transplant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026) | 20010 | Washington D.C. | District of Columbia |
| The West Clinic, PLLC dba West Cancer Center ( Site 0005) | 38138 | Germantown | Tennessee |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.