A Study of Tolododekin Alfa (ANK-101) in Renal Allograft Recipients With High Risk Cutaneous Squamous Cell Carcinoma

An Open-Label Study of Tolododekin Alfa (ANK-101) in Renal Allograft Recipients With Resectable, High-Risk Cutaneous Squamous Cell Carcinoma

A study of tolododekin alfa (also known as ANK-101) administered prior to surgery in kidney transplant participants that also have high-risk cutaneous squamous cell carcinoma (CSCC).

Inclusion Criteria:

1. Have histologically or cytologically confirmed high-risk and/or locoregionally metastatic CSCC
2. Have measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
3. Are renal allograft recipients on a stable immunosuppressive regimen.
4. Have adequate renal function defined as creatinine clearance ≥ 30 mL/min as determined by the Cockcroft-Gault equation.
5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
6. Have a life expectancy > 12 months.
7. Have baseline electrocardiogram (EKG) without evidence of acute ischemia or prolonged QT interval
8. Heterosexually active women of childbearing potential (WOCBP) must agree to use at least 2 forms of highly effective methods of contraception
9. All male participants who are not sterile must commit to the use of a reliable method of birth control or abstinence.
10. Last dose of previous anticancer therapy (including investigational agents) ≥ 28 days or surgical intervention ≥ 21 days prior to the first dose of study drug.
11. Resolution of all prior anticancer therapy toxicities (except for alopecia or vitiligo) to ≤ Grade 1
12. Willingness to provide fresh tumor biopsy specimens
13. Capable of understanding and complying with protocol requirements.
14. Provides written informed consent for the study.

Exclusion Criteria:

1. Have AJCC Stage IV disease, known distant metastasis, or findings on imaging that are considered to be highly suspicious for distant metastasis.
2. Have injectable tumors impinging upon major airways or blood vessels.
3. Have had prior treatment with recombinant interleukin-12 (IL-12).
4. Have had prior radiation therapy within 28 days for CSCC at the site of injection.
5. Have received live vaccines within 28 days prior to the start of study drug (C1D1).
6. Have any history of transplant-related deoxyribonucleic acid (DNA) viral infections, such as human polyomavirus 1 (BKV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) within 3 months of C1D1.
7. Have primary or acquired immunodeficient states (e.g., leukemia, lymphoma) requiring active therapy.
8. A WOCBP who has a positive serum pregnancy test prior to C1D1 or female participant who is breastfeeding
9. Have known active uncontrolled hepatitis B, hepatitis C (HCV), or human immunodeficiency virus (HIV) infection.
10. Have active autoimmune disease or medical conditions requiring chronic steroid (i.e., ≥ 20 mg/day prednisone or equivalent) or other immunosuppressive therapy beyond that required for maintenance allograft rejection prevention.
11. Have congestive heart failure, active coronary artery disease, unevaluated new onset angina, unstable angina, or clinically significant cardiac arrhythmias.
12. Have uncontrolled bleeding disorders.
13. Have a history of allergic reactions attributed to compounds of similar biological composition to IL-12, aluminum hydroxide, or drugs formulated with polysorbate-20.
14. Have other systemic conditions or organ abnormalities that may interfere with the conduct the current study.
15. Have any acute or chronic psychiatric problems or substance abuse disorder that make the participant unsuitable for participation.