A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Syncromune, Inc.
Study ID
NCT06533644
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Partial Oncolysis — PROCEDURE
    Partial tumor oncolysis will be completed by cryolysis.
  • SV-102 — DRUG
    Intratumoral infusion of SV-102

Study Details

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.

Key Dates

Start date
May 29, 2025
Status verified
May 2026
Primary completion
Apr 14, 2028
Completion
Apr 14, 2028

Study Design

Enrollment
91 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 - Dose Escalation, Cohort 1: Partial Oncolysis + SV-102
    Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 1.
  • Experimental: Part 1 - Dose Escalation, Cohort 2: Partial Oncolysis + SV-102
    Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 2.
  • Experimental: Part 1 - Dose Escalation, Cohort 3: Partial Oncolysis + SV-102
    Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 3.
  • Experimental: Part 2 - Dose Optimization, Arm 1: Partial Oncolysis + SV-102
    Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, dose level selected from Part 1.
  • Experimental: Part 2 - Dose Optimization, Arm 2: Partial Oncolysis + SV-102
    Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, dose level selected from Part 1.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Immune-related Adverse Reactions (imARs) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054-
University of Arizona Cancer CenterTucsonArizona85719-
University of California-DavisSacramentoCalifornia95817-
Mayo ClinicJacksonvilleFlorida32224-
University of MiamiMiamiFlorida33136-
Moffitt Cancer CenterTampaFlorida33612-
University of ChicagoChicagoIllinois60637-
Duly HealthLisleIllinois60532-
Wichita UrologyWichitaKansas67226-
Michigan Institute of UrologyTroyMichigan48084-
Mercy HospitalSt LouisMissouri63141-
University of Nebraska Medical CenterOmahaNebraska68105-
Northwell HealthLake SuccessNew York11042-
NYU LangoneNew YorkNew York10016-
Weill CornellNew YorkNew York10065-
Ohio State UniversityColumbusOhio43201-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Houston Metro UrologyHoustonTexas77027-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Phoenix, AZ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Mayo Clinic· Phoenix, AZUniversity of Arizona Cancer Center· Tucson, AZUniversity of California-Davis· Sacramento, CAMayo Clinic· Jacksonville, FLUniversity of Miami· Miami, FLMoffitt Cancer Center· Tampa, FL

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