A significant milestone has been achieved with the successful completion of the safety lead-in phase of a Phase 2 clinical trial. This trial focuses on an innovative therapy, ENV105, combined with the standard prostate cancer treatment apalutamide, offering new hope for patients who have developed resistance to existing therapies.We have already talked about ENV105 being tested to reverse  resistance to ARSIs in this past article.

The Phase 2 trial, conducted at leading cancer centers in Los Angeles and Salt Lake City, aims to evaluate the safety and efficacy of ENV105 in combination with apalutamide. The recently completed safety lead-in phase focused on assessing the tolerability of this combination therapy in patients with mCRPC. The trial also includes a biomarker validation component, designed to identify patients who are most likely to benefit from this groundbreaking treatment.

With the safety lead-in phase now complete, preliminary safety and efficacy data are expected to be released in the first half of 2025. Patient enrollment for the randomization arm of the trial continues, as researchers explore the potential of ENV105 to improve outcomes for patients with advanced prostate cancer.

This innovative trial is supported by a partnership between the National Cancer Institute (NCI) and private research initiatives, highlighting the importance of collaboration in advancing cancer treatment.

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