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

Not Applicable

Not yet recruiting

• Conditions: Cutaneous Squamous Cell Carcinoma (CSCC); Renal Transplant; Solid Tumor; Solid Tumor Cancer
• Interventions: Drug: tolododekin alfa

• Registration Number: NCT07100925
• Lead Sponsor: Ankyra Therapeutics, Inc

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-28
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03
• Study Start: 2025-12-15
• Primary Completion: 2030-06
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tolododekin alfa (ANK-101) IT Injection	tolododekin alfa	Participants will receive 2 cycles of tolododekin alfa before surgical resection of CSCC tumor

Primary Outcome Measures

Name	Time	Method
Major Pathological Response (MPR) rate	3 months	The percentage of participants who have ≤ 10% viable cancer cells in the surgical pathology sample among all response evaluable participants.

Secondary Outcome Measures

Name	Time	Method
Event Free Survival (EFS)	Up to 3 years	Time from the first dose of tolododekin alfa to date of event
Relapse Free Survival (RFS)	Up to 3 years	Time from surgical resection to the earliest date of relapse or death from any cause.
Pathological Complete Response (pCR)	3 months	The percentage of participants with complete absence of viable cancer cells in the surgical pathology sample among all response evaluable participants.
Best Overall Response Rate (BORR)	Up to 3 years	The percentage of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 among all response evaluable participants.
Overall Survival (OS)	Up to 3 years	The time from the administration of tolododekin alfa to death from any cause