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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
Partial tumor oncolysis will be completed by cryolysis.
Intratumoral infusion of SV-102
University of Arizona Cancer Center
Tucson, Arizona, United States
RECRUITINGMichigan Institute of Urology
Troy, Michigan, United States
RECRUITINGMercy Hospital
St Louis, Missouri, United States
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
Maximum Tolerated Dose
The MTD will be defined as the highest dose level below the dose level at which 2 or more participant experience a dose limiting toxicity (DLT).
Time frame: Up to 48 weeks
Optimal Biologic Dose (OBD)
OBD will be determined based on DLT and dose escalation part data.
Time frame: Up to 48 weeks
Recommended Phase 2 Dose (RP2D)
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the expansion phase, based on data collected during the dose escalation portion of the study.
Time frame: Up to 48 weeks
Objective Response Rate (ORR)
The ORR is defined as the percentage of participants who achieved best overall response (BOR) of complete response (CR) or partial response (PR).
Time frame: Up to 2 years
Duration of Response
The period from the onset of a response (e.g., tumor shrinkage or stabilization) until disease progression or death, whichever occurs first.
Time frame: Up to 2 years
Radiographic Progression-Free Survival (rPFS) per RECIST v1.1 and Prostate Cancer Working Group 3 (PCWG3)
rPFS is defined as the time from the start of study drug until first documented radiologic disease progression at the first site of disease or death from any cause, whichever comes first.
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University of Nebraska Medical Center
Omaha, Nebraska, United States
RECRUITINGUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
RECRUITINGTime frame: Up to 2 years
Progression-Free Survival (PFS)
The time interval between the start of treatment and the occurrence of disease progression or death from any cause.
Time frame: Up to 2 years
Overall survival (OS)
OS is defined as the time from the first dose of study drug to death due to any cause.
Time frame: Up to 2 years
Trough Concentration (Ctrough) of SV-102
Time frame: Pre-infusion at Day 1 of Cycle 1 up to Cycle 12 (each cycle length = 28 days)
Area Under the Concentration Time Curve From Time 0 to the Time t (AUC0-t) of SV-102
Time frame: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)
Area Under the Concentration Time Curve From Time 0 to the Last Measurable Concentration (AUC0-last) of SV-102
Time frame: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)
Maximum Observed Plasma Concentration (Cmax) of SV-102
Time frame: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)
Last Observed (Quantifiable) Concentration (Clast) of SV-102
Time frame: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)
Time to Reach the Maximum Plasma Concentration (Tmax) of SV-102
Time frame: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)
Time of Last Measurable Concentration (Tlast) of SV-102
Time frame: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)
Apparent Terminal Elimination Half-life (T1/2) of SV-102
Time frame: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)
Apparent Total Body Clearance (CL/F) of SV-102
Time frame: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)
Volume of Distribution (Vd) of SV-102
Time frame: Cycle 1: Pre-infusion up to 672 hours post-infusion; Cycle 3: Pre-infusion up to 72 hours post-infusion (each cycle length = 28 days)
Number of Participants With Any Device Constituent Failures/Malfunctions
Time frame: Up to 2 years
Number of Participants With Anti-drug Antibodies (ADA)
Time frame: Up to 2 years