A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castrate-Resistant Prostate Cancer
NCT Number: NCT06533644
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Metastatic Castration-resistant Prostate Cancer
Interventions: DRUG: SV-102
Sponsor: Syncromune, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2027-12-14

Summary:
The primary purpose of this study is to evaluate the safety and tolerability of SYNC-T Therapy SV-102 and to identify the maximum tolerated dose (MTD) and/or selected dose for phase 2 study.

Primary Outcome Measures: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Immune-related Adverse Reactions (imARs), 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)., Up to 48 weeks|Optimal Biologic Dose (OBD), OBD will be determined based on DLT and dose escalation part data., 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., Up to 48 weeks
Secondary Outcome Measures: Radiographic Progression-Free Survival (rPFS) per 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., Up to 2 years|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)., Up to 2 years|Percentage of Participants With CR, PR, Stable Disease (SD), Progressive disease (PD), CR is defined as disappearance of all target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\<) 10 millimeter (mm). PR is defined as at least a 30 percentage (%) decrease in the sum of measures (widest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-progressive disease. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on trial. PD is defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on trial (including baseline) and an absolute increase of greater than or equal to (\>=) 5 mm., 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., Up to 2 years|Trough Concentration (Ctrough) of SV-102, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, Up to 2 years|Number of Participants With Anti-drug Antibodies (ADA), Up to 2 years