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New treatment option for Metastatic Castration-resistant Prostate Cancer
Official title A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT06533644
What this study is testing
What is SV-102?
SV-102 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic castration-resistant prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join 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...
- 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...
- Progression (as defined below) after the receipt of at least one or more approved second-generation androgen-receptor-pathway inhibitors with or...
You likely can't join 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...
- 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...
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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 people who previously received lutetium Lu 177 vipivotide tetraxetan (Pluvicto®), the last dose...
- 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
- true abstinence, when this is in line with the preferred and usual lifestyle of the participants. Periodic abstinence (for example [e.g.], calendar, ovulation, symptothermal, post ovulation methods), withdrawal...
- Must have at least one measurable lesion per RECIST v1.1 at time of screening.
- Must have at least one lesion suitable for SYNC-T Therapy identified by radiographic imaging as defined below:
- Soft tissue lesion (e.g., prostate, lung) must be at least 1 cm in at least two dimensions.
- Lymph node lesion of at least 1.5 cm (short axis) or 1.0 cm if positive per PET scan.
- Exophytic component of a bone lesion that is measurable per RECIST v1.1. Soft tissue and lymph nodes must be demonstrable on CT/MRI and accessible either transperineally or percutaneously to permit tumor biopsy...
- Participants receiving bone resorptive therapy must be on stable doses for at least 42 days prior to the oncolysis.
- In the opinion of the Investigator, there is no other meaningful life prolonging therapy option available, or the participant refuses other therapy, outside of anti-hormonal therapy.
- Adequate bone marrow, renal, and hepatic function.
- Participants agrees to provide tumor tissue and undergo an on-treatment tumor biopsy.
What rules you out
- 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...
- 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...
- 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...
- Other immunodeficiency diseases that in the opinion of the Investigator, with consultation with Medical Monitor, could compromise the participant or limit treatment how well it works.
- Uncontrolled or unmanaged diabetes, hypersensitivity, or other illness or disease that in the opinion of the Investigator, with consultation with Medical Monitor (MM), makes the subject a poor candidate.
- History of bone marrow/stem cell transplant.
- Participants having human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) are not eligible for enrollment.
- Active coronavirus disease-2019 (COVID-19) infection or tests positive for COVID-19 a day before or the day of planned study treatment.
- Participants who have active viral (any etiology) hepatitis are excluded.
- Participants with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen [HBsAg] test and a positive hepatitis B core antibody (anti-HBc) test) who have a...
- Participants with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment and have a viral load below the limit of quantification are eligible for study entry. Known or...
- Participants with complications or contraindications related to the liver, including intrahepatic biliary ductal dilation, uncorrectable bleeding diathesis, and decompensated liver failure.
- Breast cancer gene (BRCA) mutation testing will be required for participants not previously treated with a PARP inhibitor, unless BRCA status is established prior to screening. If PARP-positive and participants agree to...
- Any condition(s) that, in the opinion of the Investigator, would increase the risk for toxicities from study treatment, or interfere with participants compliance or conduct of this study.
- Known visceral metastases, except for lung metastases.
- Known substance abuse or medical, psychological, or social conditions that may interfere with patient's participation.
- Participants who have received both chemotherapy and lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in the CRPC setting.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Sacramento, California, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Lisle, Illinois, United States
- Wichita, Kansas, United States
- Shreveport, Louisiana, United States
- Troy, Michigan, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Lake Success, New York, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
+ 2 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Sacramento, California, United States; Jacksonville, Florida, United States; Miami, Florida, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.