Florida Cancer Specialists Launches Phase 3 Trial of Pasritamig Bispecific T-Cell Engager for Castration-Resistant Prostate Cancer
核心洞察
Florida Cancer Specialists & Research Institute (搜索) is among the first oncology providers in Florida selected to enroll patients in a global phase 3 clinical study of pasritamig (搜索), a bispecific T-cell engager developed by Johnson & Johnson for castration-resistant prostate cancer (搜索).
Pasritamig (搜索) works by binding both the cancer cell protein KLK2 (搜索) and the T-cell receptor CD3 (搜索), bringing patients' T-cells directly to prostate cancer (搜索) cells to attack and kill the cancer.
The trial will evaluate overall survival of patients receiving pasritamig (搜索) plus best supportive care compared to placebo with best supportive care across 172 locations globally.
Florida Cancer Specialists & Research Institute (搜索) (FCS) has been selected among the first oncology providers in Florida to participate in a global phase 3 clinical trial of pasritamig (搜索), a next-generation bispecific T-cell engager developed by Johnson & Johnson for metastatic castration-resistant prostate cancer (搜索). The statewide practice is now enrolling patients in this late-phase study that represents a significant advancement in immunotherapy research for treatment-resistant prostate cancer (搜索).
Novel Mechanism Targets Treatment-Resistant Disease
Pasritamig (搜索) employs a unique mechanism of action that brings patients' T-cells directly to prostate cancer (搜索) cells by simultaneously binding the cancer cell protein KLK2 (搜索) and the T-cell receptor CD3 (搜索). This dual binding allows T-cells to attack and kill cancer cells that have become resistant to conventional hormone therapies.
"This trial represents an exciting step forward in next-generation immunotherapy research for prostate cancer (搜索)," said Bradley Monk, MD, FCS medical director of late-phase clinical research. The approach addresses a critical unmet need, as prostate cancer that has spread beyond the prostate often becomes resistant to available therapies.
Global Phase 3 Trial Design
The international study involves 172 locations worldwide and will evaluate the overall survival of patients receiving pasritamig (搜索) in combination with best supportive care (BSC) compared to placebo with BSC. This marks FCS's first enrollment in a late-phase bispecific T-cell engager clinical trial, though the practice already offers step-up dosing and maintenance therapy with FDA-approved bispecific drugs for treating recurring and resistant blood cancers and small cell lung cancer.
"Treatment-resistant cancers pose a major challenge in medicine," said Elizabeth Guancial, MD, FCS medical oncologist and hematologist serving as principal investigator. "I'm proud that FCS is helping lead this research—giving patients new hope and opportunities to participate in cutting-edge care, especially since the early phase data to support it was generated in our very own DDU."
Clinical Significance and Disease Burden
Prostate cancer (搜索) represents the most commonly diagnosed malignancy worldwide and the sixth leading cause of cancer-related death in men. While localized disease confined to the prostate is considered potentially curable, cancers that spread beyond the prostate frequently develop resistance to available therapeutic options, creating an urgent need for novel treatment approaches.
The seamless progression from early-phase research conducted in FCS's Drug Development Units to late-phase trials exemplifies how integrated research programs can accelerate patient access to promising new therapies. FCS provides ongoing access to more than 180 clinical trials across 29 clinics statewide and maintains early-phase Drug Development Units in Sarasota and Central Florida.
Research Leadership and Patient Access
FCS's participation in this pivotal trial reflects its position as a leader in clinical research among private oncology practices. The majority of new cancer drugs approved for use in the United States in recent years were studied in clinical trials with FCS participation, demonstrating the practice's significant contribution to advancing cancer treatment options.
The trial enrollment represents part of FCS's broader commitment to genitourinary cancer research, with physicians actively presenting novel clinical trial findings at major scientific meetings including the ASCO 2026 Genitourinary Cancers Symposium. Dr. Manish Patel, FCS medical director of drug development, recently presented initial results from a phase 1b study examining pasritamig (搜索) in combination with docetaxel for metastatic castration-resistant prostate cancer (搜索).