Phase 1 Trial of SYNC-T - Immunotherapy for Patients With Advanced/Metastatic Solid Tumors

Inclusion Criteria:

1. Male or female, aged >18 years old at the time of signed informed consent

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

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

4. Meet all eligibility criteria

5. Has undergone a cardiac work-up and received cardiac clearance two months beforefirst treatment

6. Has halted use of any anticoagulants or other blood thinners (including but notlimited to heparin or warfarin) within five (5) days of each treatment.

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

8. Measurable disease by RECIST.

9. Able to undergo general anesthesia or conscious sedation.

10. Eastern Cooperative Oncology Group (ECOG) performance status of < 3.

11. Women of childbearing potential (WOCBP) must have a negative serum pregnancy testwithin 7 days prior to the study.Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must be on stable dosesfor at least 42 days prior to the cryolysis

12. In the opinion of the Investigator, there is no other meaningful life-prolongingtherapy option available.

13. Adequate bone marrow, renal, and hepatic function, defined as follows: a. Bone marrow function without transfusion 30 days before first dosing: i. Absoluteneutrophil count ≥ 1.5 x 109/L; Lymphocyte count of ≥ 1.0 x 109/L; Platelet count ≥ 100 x 109/L; ii. Hemoglobin ≥ 9.0 g/dL b. Renal function: i. Estimated glomerularfiltration rate ≥30 mL/min/1.73 m2 or creatinine clearance calculated byCockcroft-Gault equation ≥30 mL/ c. Hepatic function: i. Alanine aminotransferase ≤ 3x upper limit of normal (ULN) ii. Aspartate aminotransferase ≤ 3x ULN iii. Totalbilirubin ≤ ULN or total bilirubin ≤ 1.5x ULN with direct bilirubin ≤ ULN of thelaboratory in subjects with documented Gilbert's Syndrome iv. Patients with livermetastases ≤5x ULN

14. All clinically relevant toxicities related to prior anticancer therapy must haverecovered to Grade ≤1 or baseline (except alopecia or ototoxicity

15. All subjects with female partners of childbearing potential must use effectivecontraception throughout study treatment and for 120-150 days (4-5 months) after thelast dose of study intervention

16. Has at least one lesion that is demonstrable on PET/CT, CT, Ultrasound, or MRI andis accessible for injection

Exclusion criteria:

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

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

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

4. Has a history of (non-infectious) pneumonitis that required steroids or currentpneumonitis

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

6. Is currently participating in or has participated in a study of an investigationalagent or has used an investigational device within 4 weeks prior to the firsttreatment

7. Has tumor volume or disease burden too great to provide for safe and/or effectivetreatment as determined by the Principal Investigator after consultation withSyncromune's Chief Medical Officer

8. Subjects who have metastases limited to subcutaneous regions (only skin)

9. Significant cardiac or other medical illness such as severe congestive heartfailure, unstable angina, or serious cardiac arrhythmia (e.g., New York HeartAssociation Class 4), or history of previous heart failure.

10. Malignant pleural effusions or ascites that require immediate intervention

11. Prior history of autoimmune disease except hypothyroidism

12. Any primary or acquired immunodeficiency

13. Active COVID infection or tests positive for COVID day before or day of plannedtreatment

14. Known or suspected hepatitis B if active infection (subjects with chronic hepatitisB infection must have an undetectable Hepatitis B virus (HBV) viral load onsuppressive therapy, if indicated; positive surface antibody alone is not anexclusion)

15. Known or suspected hepatitis C infection which has not been treated and cured unlesscurrently on treatment with an undetectable viral load

16. Prior history of autoimmune disease except hypothyroidism, uncontrolled or unmanageddiabetes, cardiac arrhytmia (unstable or untreated), hypersensitivity, or otherillness or disease that in the opinion of the Principal Investigator, withconsultation with Syncromune's Chief Medical Officer, makes the subject a poorcandidate.Any condition(s) that, in the opinion of the Investigator, would increasethe risk for toxicities from study drug, interfere with subject compliance orconduct of this study