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)
Syncromune, Inc.
Summary
The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of SYNC-T Therapy SV-102 and to identify the maximum tolerated dose (MTD) and/or selected dose for phase 2b study.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Male \>=18 years old. * Able to provide written informed consent and comply with the study procedures. * Participants with advanced and/or metastatic histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology or neuroendocrine transformation. * Serum testosterone levels less than or equal to (\<=) 0.5 nanograms per millilitre (ng/mL) (\<=1.73 nanomoles per litre \[nmol/L\]) at screening if on an androgen receptor prostate inhibitor in combination with Androgen Deprivation Therapy (ADT). * Progression (as defined below) after the…
Interventions
- ProcedurePartial Oncolysis
Partial tumor oncolysis will be completed by cryolysis.
- DrugSV-102
Intratumoral infusion of SV-102
Locations (23)
- Mayo ClinicPhoenix, Arizona
- University of Arizona Cancer CenterTucson, Arizona
- Arkansas UrologyLittle Rock, Arkansas
- University of California-DavisSacramento, California
- Mayo ClinicJacksonville, Florida
- University of MiamiMiami, Florida