A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors

Inclusion Criteria:

1. Subject is capable of understanding the purpose and risks of the study and hasprovided written Informed Consent.

2. Subject is male or female, aged at least 18 years.

3. Subject has a histologically or cytologically confirmed diagnosis of an advancedmalignant solid tumor(s) who have received all conventional therapies consideredappropriate by Investigator and have a tumor that is easily accessible and/orpalpable for treatment. Ultrasound guidance may be used to aid administration.

4. Subject's Eastern Cooperative Group (ECOG) performance status is 0-1 at Screening.

5. Subject has acceptable liver function at Screening, as evidenced by:

6. Bilirubin < 1.5 x ULN (upper limit of normal)

7. AST (SGOT) and ALT (SGPT) < 3.0 x ULN (upper limit of normal)

8. Alkaline Phosphatase < 2.5 x ULN (upper limit of normal)

9. Subject has a Serum Creatinine < 1.5 x ULN (upper limit of normal)

10. Subject has acceptable hematologic status at Screening, as evidenced by:

11. Absolute neutrophil count > 1,500 cells/mm3; > 1.5 x 109/L, and

12. Platelet count > 75,000/mm3; > 75.0 x 109/L, and

13. Hemoglobin (HGB) ≥ 8.0 g/dL; ≥ 5.6 mmol/L

14. Subject has an INR < 1.5

15. Female subjects of childbearing potential (i.e., women who have not been surgicallysterilized or have not been post-menopausal for at least one year), and malesubjects with partners of childbearing potential, must agree to use medicallyacceptable methods of contraception beginning on Study Day 1 and continuing until atleast four weeks after administration of the subject's final dose of AdAPT-001.Medically acceptable contraception is defined as either: 1) usage by at least one ofthe partners of a barrier method of contraception, together with usage by the femalepartner, commencing at least three months prior to Study Day 1, of a stable regimenof any form of hormonal contraception or an intra-uterine device, or 2) usage by thecouple of a double-barrier method of contraception. Use of a single-barrier methodalone or abstinence alone is not considered adequate.

16. Subject is willing and able to comply with all protocol procedures, evaluations andrescue measures.

17. OPTIONAL: Archival formalin-fixed paraffin-embedded block(s) or previously cutarchival tissue for at least 5 unstained slides (if available).

Exclusion Criteria:

1. Presence of a serious co-morbid medical condition, or a clinically significantlaboratory finding(s) that, in the opinion of the Investigator, suggests thepresence of an infectious, endocrine, and/or other inadequately treated systemicdisorder.

2. A known uncontrolled active bacterial, fungal, or viral infection. No subject withan active SARS-CoV-2 infection (within 14 days of a positive test)

3. Known positive history of human immunodeficiency virus (HIV) test

4. Subjects who have active hepatitis.

5. If female, subject is pregnant and/or breastfeeding.

6. Subjects with active autoimmune disease or history of autoimmune disease that mightrecur and may affect vital organ function or require immune suppressive treatmentincluding systemic corticosteroids, should be excluded. Note: Subjects in any condition requiring systemic treatment with corticosteroids (prednisone > 10 mg/day or equivalent of the similar drug) or otherimmunosuppressive agents within 14 days before AdAPT-001), but currently orpreviously treated with any of the following steroid regimens were included:Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids withminimal systemic absorption; prophylactic short-term use of corticosteroids.

7. Prior adenoviral therapy for any indication except vaccination against infectiousdisease. Subjects receiving COVID-19 or live vaccination, cannot start treatmentuntil 7 days after completing the vaccination. Recommend waiting at least 28 daysfrom AdAPT-001 dose prior to receiving COVID-19 vaccination. Concurrent treatmentwith Evusheld is allowed.

8. Chemotherapy or immunotherapy within 14 days of study treatment. Hormonal therapy (including tamoxifen, aromatase inhibitors, and gonadotropin releasing hormoneagonists) is allowed. Concurrent treatment with bisphosphonate and RANK ligandinhibitor is allowed.