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)
Categories (click each to see list of all clinical trials associated with that category): GU (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Teply, Benjamin
Contact Information:
Heather Mittelstedt
hmittelstedt@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06533644?term=NCT06533644&rank=1&tab=table#trial-description
Summary
Primary Objectives:
-To evaluate the safety and tolerability of SYNC-T Therapy SV-102. (Part 1 and Part 2). -To identify the maximum tolerated dose (MTD) and/or selected doses for optimization (Part 1 only). -To identify the recommended phase 2b dose (RP2bD) (Part 2 only). -To evaluate the efficacy of SYNC-T Therapy SV-102 per RECIST 1.1 and PCWG3. (Part 1 and Part 2).
Secondary Objectives:
-To further evaluate the efficacy of SYNC-T Therapy SV-102 (Part 1 and Part 2). -To characterize the pharmacokinetic (PK) profile for each of the APIs present in SV-102 at each dose level (Part 1 and Part 2). -To capture any device constituent failures/malfunctions (Part 1 and Part 2). -To assess the immunogenicity of each of the SV-102 APIs (Part 1 and Part 2).
Exploratory Objectives:
-To evaluate the efficacy of SYNC-T SV-102 Therapy by other endpoints (Part 1 and Part 2). -To evaluate the efficacy of SYNC-T Therapy SV-102 according to iRECIST (Part 1 and Part 2). -To further assess the effect of SYNC-T Therapy SV-102 in treated lesions on disease-related symptoms and health-related quality of life (HRQoL) (Part 1 and Part 2).
-To assess preliminary pharmacodynamic and biomarker characteristics (Part 1 and Part 2). -To assess the effect of SYNC-T Therapy SV-102 by PRO data (Part 1 and Part 2). -PSMA-PET Scan (Part 1 (optional) and Part 2).