A Phase 2a Multicenter Dose Escalation and Dose Optimization Study of SYNC-T Therapy SV-102 for Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Brief description of study
This is a Phase 2 study testing a treatment called SYNC-T Therapy SV-102 in adult men with metastatic castration-resistant prostate cancer (mCRPC). SYNC-T Therapy SV-102 uses a special device to freeze and break down (called oncolysis) the cancer in the tumor. After that, the treatment gives a 15 ml dose of a drug called SV-102 directly into the tumor. SV-102 is made up of 4 different biologic drugs (YH001, 609A, YH003, and HP007). This combination treatment is designed to help the immune system fight the cancer by overcoming the tumor’s ability to protect itself from immune attacks. The study will check if this treatment is safe, effective, and tolerable.
In this study, there are two parts: Part 1 (dose escalation) and Part 2 (dose optimization). In Part 1, patients will be enrolled and divided into 3 e cancer cells that depend on it. The goal of this study is to find out whether adding ADI-PEG 20 to standard treatment helps patients live longer without their cancer getting worse, compared to standard treatment alone.
groups (dose cohorts). Each group will receive increasing doses of SV-102 combined with partial oncolysis. The goal is to find the highest dose of SV-102 that can be safely given (called the maximum tolerated dose or MTD) and select the best doses for the next part of the study. The doses will increase using a modified 3+3 rule, meaning the doses will go up based on how patients respond to treatment. Once the dose escalation phase is complete, the Safety Review Committee (SRC) will review how well patients tolerated the doses, the effectiveness of the treatment, and if available, any data on how the drug behaves in the body (called pharmacokinetics (PK), pharmacodynamics (PD), and biomarkers). Based on this review, 2 doses will be selected to continue to Part 2 of the study. In Part 2, patients will be randomly assigned to receive one of the two selected doses selected from Part 1. After treatment ends, patients will be monitored for safety.All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicines. The study team will have special scans done for all patients to see how the cancer is responding to the study medicines. The study team will be monitoring the patients for potential side effects and safety concerns.
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