A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorSyncromune, Inc.
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
Has a known other primary malignancy other than prostate cancer that is progressing or has required active treatment in the last 3 years, excluding basal and squamous cell carcinoma, papillary thyroid cancer, and ductal carcinoma in situ of the breast.
Has an obstructed urinary system before or after stenting.
Has undergone major surgery, including local prostate intervention (excluding prostate biopsy), within 28 days prior to the first dose of study treatment and has not recovered adequately from the toxicities and/or complications.
Has used any anticoagulants or other blood thinners pre-study treatments within the protocol-defined timelines.
Trial design
Treatments tested in this trial
- Partial Oncolysis
- SV-102
Treatment groups
91 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov