UPDATE: PGV001 Trial Focused on Prostate Cancer

Mount Sinai is testing a personalized vaccine designed to help the immune system recognize and attack residual prostate-cancer cells. The phase 1 trial is evaluating PGV001, a multi-peptide vaccine created from each patient’s own tumor mutations, in combination with CDX-301, a cytokine intended to strengthen the immune response. Unlike a preventive vaccine, this is a […]

Phase 1/2 Trial for CRG-150, a New Approach to Immunotherapy

CRG-150 is entering first-in-human testing as an unconventional immunotherapy for patients with relapsed or refra9ctory metastatic prostate cancer and other solid tumors. The autologous, CRISPR-edited cell therapy targets steroid receptor coactivator 3, or SRC-3, in regulatory T cells. Tregs help maintain immune tolerance but can suppress antitumor immunity in prostate cancer. By disrupting SRC-3, CRG-150 […]

Phase 1 Trial: Boosting Sipuleucel‑T with N‑803

Fifteen years after sipuleucel‑T became the first cellular immunotherapy to show an overall‑survival benefit in metastatic castration‑resistant prostate cancer (mCRPC), a new phase Ib trial at Washington University is testing whether adding the IL‑15 superagonist N‑803 (Anktiva) can turn that modest, durable survival signal into a stronger, more consistent immune attack on metastatic disease. The […]

Soon to Be Phase 1/2 Trial: Bria-PROS+ Receives FDA Clearance to Begin Clinical Study in Prostate Cancer

Bria-PROS+ has received clearance from the U.S. Food and Drug Administration to enter clinical testing as an investigational personalized, off-the-shelf cellular immunotherapy for prostate cancer. The FDA completed its review of the Investigational New Drug application allowing a Phase 1/2a clinical study to move forward. The study is expected to evaluate the safety, tolerability, and […]

UPDATE: Seven Complete Responses in a 19-Patient Cohort of 67Cu-SAR-bisPSMA Trial for mCRPC

A small but encouraging clinical dataset suggests that 67Cu-SAR-bisPSMA may produce substantial anti-tumour activity in patients with metastatic castration-resistant prostate cancer (mCRPC) who have exhausted multiple treatment options. The findings come from the SECuRE clinical trial, in which 19 participants received treatment with 67Cu-SAR-bisPSMA at an 8 GBq dose. Despite the advanced disease setting, treatment […]

Pluvicto Moves Into First-Line Metastatic Prostate Cancer, Marking Shift Toward Earlier Radioligand Therapy

A new regulatory approval is reshaping the treatment landscape for metastatic hormone-sensitive prostate cancer (mHSPC), bringing radioligand therapy into much earlier stages of disease. Pluvicto (lutetium Lu-177 vipivotide tetraxetan aka 177Lu-PSMA-617), a therapy targeting prostate-specific membrane antigen (PSMA), can now be used in combination with standard androgen deprivation therapy and androgen receptor pathway inhibitors in […]

Phase 2 Trial for Xaluritamig in Patients With mCRPC and Suboptimal Response to Pluvicto

Thomas Jefferson University is running a phase 2 study of xaluritamig, also known as AMG 509, in adults with metastatic castration-resistant prostate cancer whose disease has shown a suboptimal response to Lu-177 vipivotide tetraxetan (aka 177Lu-PSMA 617) the radioligand therapy better known as Pluvicto. The trial reflects a very specific and clinically important question: what […]

Phase 1 Trial for ASP388B

ASP388B is an experimental anticancer drug now being tested in a first-in-human study for people with advanced solid tumors, including mCRPC. The public trial record shows it is being studied both alone and in combination with standard treatments, but its exact molecular target has not been publicly disclosed in the materials I could verify. In […]

UPDATE: FX-111 Entered Clinical Trials Phase

The first-in-human Phase 1 trial is designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and early signs of anti-tumor activity for FX-111 just started recruiting. We already talked about the rationale behind it in this post. FX-111 is a selective degrader of ARon, the transcriptionally active, hormone-bound form of the androgen receptor. That distinction matters because […]

Mitochondrial Fitness and Endurance May Help Men With Prostate Cancer Tolerate Androgen Deprivation Therapy Better

A study published in Nature Communications, “Muscle mitochondria, function, mass, and quality of life in prostate cancer during androgen deprivation therapy,” looked at how muscle health affects men with advanced prostate cancer during androgen deprivation therapy. The researchers followed 60 patients over six months and assessed body composition, strength, endurance, quality of life, and skeletal […]