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

NCT06533644 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: LEGION-100-2a
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 23

Brief Summary

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.

Conditions

Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (5)

• 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

• 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

Secondary Outcomes (16)

• Duration of Response

  Up to 2 years

• Radiographic Progression-Free Survival (rPFS) per RECIST v1.1 and Prostate Cancer Working Group 3 (PCWG3)

  Up to 2 years

• Progression-Free Survival (PFS)

  Up to 2 years

• Overall survival (OS)

  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)

Study Arms (5)

Part 1 - Dose Escalation, Cohort 1: Partial Oncolysis + SV-102

EXPERIMENTAL

Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 1.

Procedure: Partial Oncolysis; Drug: SV-102

Part 1 - Dose Escalation, Cohort 2: Partial Oncolysis + SV-102

EXPERIMENTAL

Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 2.

Procedure: Partial Oncolysis; Drug: SV-102

Part 1 - Dose Escalation, Cohort 3: Partial Oncolysis + SV-102

EXPERIMENTAL

Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, Dose Level 3.

Procedure: Partial Oncolysis; Drug: SV-102

Part 2 - Dose Optimization, Arm 1: Partial Oncolysis + SV-102

EXPERIMENTAL

Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, dose level selected from Part 1.

Procedure: Partial Oncolysis; Drug: SV-102

Part 2 - Dose Optimization, Arm 2: Partial Oncolysis + SV-102

EXPERIMENTAL

Participants will receive partial oncolysis plus an intratumoral infusion of SV-102, dose level selected from Part 1.

Procedure: Partial Oncolysis; Drug: SV-102

Interventions

Partial Oncolysis PROCEDURE

Partial tumor oncolysis will be completed by cryolysis.

Also known as: cryolysis

Part 1 - Dose Escalation, Cohort 1: Partial Oncolysis + SV-102; Part 1 - Dose Escalation, Cohort 2: Partial Oncolysis + SV-102; Part 1 - Dose Escalation, Cohort 3: Partial Oncolysis + SV-102; Part 2 - Dose Optimization, Arm 1: Partial Oncolysis + SV-102; Part 2 - Dose Optimization, Arm 2: Partial Oncolysis + SV-102

SV-102 DRUG

Intratumoral infusion of SV-102

Part 1 - Dose Escalation, Cohort 1: Partial Oncolysis + SV-102; Part 1 - Dose Escalation, Cohort 2: Partial Oncolysis + SV-102; Part 1 - Dose Escalation, Cohort 3: Partial Oncolysis + SV-102; Part 2 - Dose Optimization, Arm 1: Partial Oncolysis + SV-102; Part 2 - Dose Optimization, Arm 2: Partial Oncolysis + SV-102

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Progression (as defined below) after the receipt of at least one or more approved second-generation androgen-receptor-pathway inhibitors with or without a prior course of taxane therapy, as long as the subject has not received more than three lines of therapy in the CRPC setting. If a subject is known positive for any of the specific gene mutations of BRCA1/2, PALB2, or HRD and chose not to receive an approved PARP-inhibitor they are eligible for the study. Documented progressive disease at screening as assessed by the Investigator with at least one of the following criteria:
• Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week apart. 1.0 ng/mL is the minimal starting value if confirmed rise is only indication of progression.
• Radiographic disease progression in soft tissue based on response evaluation criteria in solid tumors (RECIST) v1.1 criteria with or without PSA progression as per prostate cancer working group 3 (PCWG3).
• Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on a bone scan as per PCWG3 with or without PSA progression.
• Able to undergo general anesthesia, MAC anesthesia, or conscious sedation.
• Eastern Cooperative Oncology Group (ECOG) performance status of less than (\<) 2.
• Life expectancy \>=6 months
• Last dose of previous anticancer therapy (excluding hormonal therapy) must by 28 days prior to first study treatment. For subjects who previously received lutetium Lu 177 vipivotide tetraxetan (Pluvicto®), the last dose must have been administered \> 90 days prior to first study treatment. Subjects may remain on ADT and/or androgen receptor pathway inhibitor at time of study entry, per Investigator discretion.
• Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy.
• For males with female partners of childbearing potential, even if surgically sterilized (that is \[i.e.\], status post vasectomy), who agree to practice:
• effective barrier contraception during the treatment period and through 120-150 days after last dose, OR

You may not qualify if:

• 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.
• Has an active infection (including tuberculosis) requiring systemic therapy.
• Has a history of non-infectious pneumonitis that requires steroids.
• Has received a live vaccine within 30 days prior to the planned first study treatment.
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days prior to the first study treatment.
• Significant cardiac or other medical illness such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia (e.g., New York Heart Association Class 4), or history of previous heart failure.
• Fridericia corrected QT interval (QTcF) greater than (\>) 470 millisecond (msec) (men) on a 12-lead electrocardiogram (ECG) during the screening period.
• Malignant pleural effusions or ascites that require immediate intervention.
• Brain metastases (includes history of).
• Immunocompromised status due to:
• Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including CNS, heart, lungs, kidneys, skin, and GI tract will be allowed.
• Other immunodeficiency diseases that in the opinion of the Investigator, with consultation with Medical Monitor, could compromise the participant or limit treatment efficacy.

Sponsors & Collaborators

• Syncromune, Inc.: lead

Study Sites (23)

Mayo Clinic

Phoenix, Arizona, 85054, United States

NOT YET RECRUITING

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

RECRUITING

Arkansas Urology

Little Rock, Arkansas, 72211, United States

NOT YET RECRUITING

University of California-Davis

Sacramento, California, 95817, United States

RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

Duly Health

Lisle, Illinois, 60532, United States

RECRUITING

Wichita Urology

Wichita, Kansas, 67226, United States

RECRUITING

Willis Knighton

Shreveport, Louisiana, 71105, United States

NOT YET RECRUITING

Michigan Institute of Urology

Troy, Michigan, 48084, United States

RECRUITING

Mercy Hospital

St Louis, Missouri, 63141, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68105, United States

RECRUITING

Northwell Health

Lake Success, New York, 11042, United States

RECRUITING

NYU Langone

New York, New York, 10016, United States

RECRUITING

Weill Cornell

New York, New York, 10065, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43201, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

NOT YET RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Houston Metro Urology

Houston, Texas, 77027, United States

NOT YET RECRUITING

Summit Urology

Murray, Utah, 84107, United States

NOT YET RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

Study Officials

• Stephen Dale, MD

  Syncromune, Inc.

  STUDY DIRECTOR

Central Study Contacts

Central Contact

CONTACT

888-636-5344; info@legion100trial.com

www.legion100trial.com

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 of the study is a dose escalation design followed by Part 2 randomized, dose optimization design.

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 1, 2024
• Study Start: May 29, 2025
• Primary Completion (Estimated): April 14, 2028
• Study Completion (Estimated): April 14, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)