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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Partial Oncolysis
Procedure/SurgeryPartial tumor oncolysis will be completed by cryolysis.
SV-102
DrugIntratumoral infusion of SV-102
Treatment groups
91 Participants
are divided into 5 treatment groupsGroup A: Part 1 - Dose Escalation, Cohort 1: Partial Oncolysis + SV-102Experimental treatment 2 interventions
Group B: Part 1 - Dose Escalation, Cohort 2: Partial Oncolysis + SV-102Experimental treatment 2 interventions
Group C: Part 1 - Dose Escalation, Cohort 3: Partial Oncolysis + SV-102Experimental treatment 2 interventions
Group D: Part 2 - Dose Optimization, Arm 1: Partial Oncolysis + SV-102Experimental treatment 2 interventions
Group E: Part 2 - Dose Optimization, Arm 2: Partial Oncolysis + SV-102Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 years2
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 weeks3
Optimal Biologic Dose (OBD)
OBD will be determined based on DLT and dose escalation part data.
Time frame
Up to 48 weeks4
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 weeksSecondary outcomes
1
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 years2
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.
Time frame
Up to 2 years3
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 years4
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 yearsSponsors and contacts
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Source ClinicalTrials.gov