Clinical Trial 23731

• Overview

  Study Title:

  A Phase 2a Multicenter Dose Escalation and Dose Optimization Study of SYNC-T Therapy SV-102 for Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) (LEGION-100-2a)

  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.

  Objective:

  Primary Objectives: -To evaluate the safety and tolerability of SYNC-T Therapy SV-102. (Part 1 and Part 2) -To identify the maximum tolerated dose (MTD) and/or selected doses for optimization (Part 1 only) -To identify the recommended phase 2b dose (RP2bD) (Part 2 only) -To evaluate the efficacy of SYNC-T Therapy SV-102 per RECIST 1.1 and PCWG3. (Part 1 and Part 2) Secondary Objectives: -To further evaluate the efficacy of SYNC-T Therapy SV-102 (Part 1 and Part 2) -To characterize the pharmacokinetic (PK) profile for each of the APIs present in SV-102 at each dose level (Part 1 and Part 2) -To capture any device constituent failures/malfunctions (Part 1 and Part 2) -To assess the immunogenicity of each of the SV-102 APIs (Part 1 and Part 2)

• Treatments

  Therapies:

  Immunotherapy

  Medications:

  SV-102 ()

• Inclusion Criteria

  > Male 18 years old or older
  • 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.
  • Serum testosterone levels less than or equal to (> Progression after the receipt of one or more approved second-generation androgen-receptor-pathway inhibitors with or without a prior course of taxane therapy, and those who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available, and has not received more than three prior lines of therapy. If a poly adenosine diphosphate ribose (ADP)-ribose polymerase (PARP)-positive participants chose not to receive an approved PARP-inhibitor they will be eligible for the study.
  • Able to undergo general anesthesia or conscious sedation.
  • Has undergone a cardiac work-up and received cardiac clearance within 2 months before first treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than (> Life expectancy >=6 months
  • Last dose of previous anticancer therapy (excluding hormonal therapy) must by 28 days or more prior to first study treatment.
  • 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: (1) effective barrier contraception during the treatment period and through 120-150 days after last dose, OR (2) 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, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.
  • Has at least one lesion of at least 1 centimeter (cm), measurable in at least two dimensions within the prostate accessible transperineally using transrectal ultrasound (TRUS) that is demonstrable on magnetic resonance imaging (MRI)/computed tomography (CT) and is accessible for infusion on TRUS or, if a radical prostatectomy has been performed, has a metastatic lesion of at least 1 cm or lymph node lesion of at least 1.5 cm, that is demonstrable on MRI/CT and accessible by a percutaneous needle to permit both tumor biopsy and immunotherapy infusion. The eligible tumor lesion for intratumoral-infusion cannot be a tumor that is adjacent to vital structures such as major nerves or blood vessels or at risk of airway compromise in the event of post-infusion tumor swelling/inflammation.
  • 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 agree to provide tumor tissue and undergo an on-treatment tumor biopsy.

• Exclusion Criteria

  Exclusion Criteria:
  • Known other primary malignancy other than prostate cancer that is progressing or has required active treatment in the last 3 years, excluding basal & squamous cell carcinoma, papillary thyroid cancer, & ductal carcinoma in situ of the breast.
  • 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 & has not recovered adequately from the toxicities &/or complications.
  • Has used any anticoagulants or other blood thinners pre-study treatments within the protocol-defined timelines.
  • Active infection (including tuberculosis) requiring systemic therapy.
  • History of non-infectious pneumonitis that requires steroids.
  • Received a live vaccine within 30 days prior to the enrollment.
  • 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, 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).
  • Prior history of autoimmune disease except hypothyroidism, uncontrolled or unmanaged diabetes (glycated haemoglobin [HbA1c] >=6.5), cardiac arrhythmia (unstable or untreated), hypersensitivity, or other illness or disease that in the opinion of the Principal Investigator, with consultation with Syncromune's Chief Medical Officer, makes the participant a poor c&idate.
  • 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 & a positive hepatitis B core antibody (anti-HBc) test) who have a viral load below the limit quantification (HBV deoxyribonucleic acid [DNA] titer > Participants with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment & have a viral load below the limit of quantification are eligible for study entry. Known or suspected hepatitis C infection which has not been treated & cured are not eligible. Known or suspected hepatitis C currently on treatment with an undetectable viral load are eligible. Patients with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment & have a viral load below the limit of quantification are eligible for study entry.
  • Participants with complications or contraindications related to the liver, including intrahepatic biliary ductal dilation, uncorrectable bleeding diathesis, & decompensated liver failure, tumor burden of over 5 lesions, tumors greater than 5 cm in size, tumors in close proximity to vital structures, such as portal vein, biliary tree, or gastrointestinal tract.
  • Other exclusions apply

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