Investigator Initiated Trial of Syncrovax - Immunotherapy for Patients With Advanced/Metastatic Solid Tumors

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

SV-101 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immuno-pharmacologic effects.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Williams Cancer Foundation
• Collaborator: Syncromune, Inc.

Criteria

Inclusion Criteria:

1. Male or female, aged >18 years.

2. Provide written informed consent and must be willing to adhere with treatment and follow-up.

3. Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available.

4. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v5 grade ≤ 1.

5. Measurable disease by RECIST.

6. Able to undergo general anesthesia or conscious sedation

7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

8. Adequate organ and bone marrow function as defined below:

1. Absolute neutrophil count (ANC) 1.5 X 109/L

2. Hemoglobin 9 g/dL (5.6 mmol/L)

3. Platelets 100 X 109/L

4. Prothrombin time (PT) or international normalized ratio (INR) 1.2 X upper limit of normal (ULN)

5. Activated partial thromboplastin time (aPTT) 1.2 X ULN

6. Total bilirubin 1.5 X ULN

7. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) 2.5 X ULN

8. Serum creatinine <1.5 x ULN Or, if >1.5 mg/dL: Calculated creatinine clearance 50 mL/min Urine Protein to Creatinine Ratio (UPC) e <1

9. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the study.

Exclusion Criteria:

1. Has bone metastasis as the only site of disease

2. Has a known additional malignancy that is progressing or has required active treatment in the last 3 years, excluding basal and squamous cell carcinoma

3. Has undergone major surgery within 28 days prior to enrollment and has not recovered adequately from the toxicities and/or complications

4. Has an active infection (including tuberculosis) requiring systemic therapy

5. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis

6. Has received a live vaccine within 30 days prior to enrollment

7. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first treatment

8. 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)

9. Visceral disease (liver or lung), brain metastases, malignant pleural effusions, or malignant ascites

10. Prior history of autoimmune disease except hypothyroidism

11. Any primary or acquired immunodeficiency

12. Active COVID infection or tests positive for COVID day before or day of planned treatment