Ifinatamab Deruxtecan for Prostate Cancer

The trial aims to test the safety and effectiveness of ifinatamab deruxtecan (I-DXd) for treating metastatic castration-resistant prostate cancer (mCRPC), a type of prostate cancer that has spread and does not respond to hormone therapy. Researchers are exploring I-DXd alone and in combination with other treatments to determine the best dose and assess its impact on prostate-specific antigen (PSA) levels, which are markers of prostate cancer. Ideal participants have prostate cancer that has spread and have not succeeded with certain hormone therapies. As a Phase 1/Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in prostate cancer treatment.

The trial does not specify if you need to stop taking your current medications. However, if you are on bone resorptive therapy, you must have been on a stable dose for at least 4 weeks before joining the trial.

Research has shown that ifinatamab deruxtecan (I-DXd) is generally safe for individuals who have undergone extensive previous treatments, indicating that many can tolerate it well. In studies, some participants experienced side effects, but these were usually manageable. The treatment also demonstrated promise in reducing tumor size.

When combined with other treatments like ARPI, which includes drugs such as abiraterone or enzalutamide, the goal is to determine the appropriate dose and ensure safety. Abiraterone and enzalutamide are already used for prostate cancer, providing some confidence in their safety.

For those taking I-DXd with MK-5684, researchers are still evaluating the safety of this combination. As this is an early-stage study (phase 1/2), they continue to gather information on how well participants tolerate it.

Unlike the standard treatments for prostate cancer, such as chemotherapy with docetaxel, Ifinatamab Deruxtecan (I-DXd) is an antibody-drug conjugate that specifically targets cancer cells, delivering chemotherapy directly to them. This targeted approach aims to minimize damage to healthy cells, potentially reducing side effects compared to traditional chemotherapy. Additionally, when combined with androgen receptor pathway inhibitors like Abiraterone or Enzalutamide, or with the experimental agent MK-5684, I-DXd offers a novel strategy by simultaneously disrupting multiple cancer growth pathways, which could enhance its effectiveness against prostate cancer. Researchers are excited because these features could lead to more effective and less toxic treatment options for patients.

Research has shown that ifinatamab deruxtecan (I-DXd), one of the treatments studied in this trial, could be a promising option for advanced prostate cancer that no longer responds to hormone therapy. Studies have found that about one in three patients experienced a significant positive response to this treatment. I-DXd delivers chemotherapy directly to cancer cells, helping to stop their growth. In this trial, some participants will receive I-DXd alone, while others will receive it in combination with treatments like abiraterone or enzalutamide, or with another drug called MK-5684. Early results suggest that I-DXd, either alone or in combination, has promising effects with manageable side effects. Overall, this treatment offers hope for those with advanced prostate cancer, especially for those who have tried other treatments without success.¹²⁵⁶⁷