Not Yet RecruitingPhase 1

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

20 participantsStarted 2025-12-15

Plain-language 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).

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. Have histologically or cytologically confirmed high-risk and/or locoregionally metastatic CSCC
✓. Have measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
✓. Are renal allograft recipients on a stable immunosuppressive regimen.
✓. Have adequate renal function defined as creatinine clearance ≥ 30 mL/min as determined by the Cockcroft-Gault equation.
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
✓. Have a life expectancy \> 12 months.
✓. Have baseline electrocardiogram (EKG) without evidence of acute ischemia or prolonged QT interval
✓. Heterosexually active women of childbearing potential (WOCBP) must agree to use at least 2 forms of highly effective methods of contraception

Exclusion criteria

✕. Have AJCC Stage IV disease, known distant metastasis, or findings on imaging that are considered to be highly suspicious for distant metastasis.
✕. Have injectable tumors impinging upon major airways or blood vessels.
✕. Have had prior treatment with recombinant interleukin-12 (IL-12).
✕. Have had prior radiation therapy within 28 days for CSCC at the site of injection.
✕. Have received live vaccines within 28 days prior to the start of study drug (C1D1).
✕. 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.
✕. Have primary or acquired immunodeficient states (e.g., leukemia, lymphoma) requiring active therapy.
✕. A WOCBP who has a positive serum pregnancy test prior to C1D1 or female participant who is breastfeeding

What they're measuring

Major Pathological Response (MPR) rate

Timeframe: 3 months

Trial details

NCT IDNCT07100925

SponsorAnkyra Therapeutics, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-06

Contact for this trial

Gail Iodice, BSN, RN

347-882-1147 giodice@ankyratx.com

View on ClinicalTrials.gov More Cutaneous Squamous Cell Carcinoma (CSCC) trials