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

NCT07100925 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: ANK-101-003
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Cutaneous Squamous Cell Carcinoma (CSCC); Renal Transplant; Solid Tumor; Solid Tumor Cancer

Keywords

intratumoral injection; intratumoral

Outcome Measures

Primary Outcomes (1)

• Major Pathological Response (MPR) rate

  The percentage of participants who have ≤ 10% viable cancer cells in the surgical pathology sample among all response evaluable participants.

  3 months

Secondary Outcomes (5)

• Event Free Survival (EFS)

  Up to 3 years

• Relapse Free Survival (RFS)

  Up to 3 years

• Pathological Complete Response (pCR)

  3 months

• Best Overall Response Rate (BORR)

  Up to 3 years

• Overall Survival (OS)

  Up to 3 years

Study Arms (1)

tolododekin alfa (ANK-101) IT Injection

EXPERIMENTAL

Participants will receive 2 cycles of tolododekin alfa before surgical resection of CSCC tumor

Drug: tolododekin alfa

Interventions

tolododekin alfa DRUG

IT administration of ANK-101 once every 3 weeks for 2 cycles, followed by surgical resection

tolododekin alfa (ANK-101) IT Injection

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• All male participants who are not sterile must commit to the use of a reliable method of birth control or abstinence.
• Last dose of previous anticancer therapy (including investigational agents) ≥ 28 days or surgical intervention ≥ 21 days prior to the first dose of study drug.
• Resolution of all prior anticancer therapy toxicities (except for alopecia or vitiligo) to ≤ Grade 1
• Willingness to provide fresh tumor biopsy specimens
• Capable of understanding and complying with protocol requirements.
• Provides written informed consent for the study.

You may not qualify if:

• 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
• Have known active uncontrolled hepatitis B, hepatitis C (HCV), or human immunodeficiency virus (HIV) infection.
• 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.
• Have congestive heart failure, active coronary artery disease, unevaluated new onset angina, unstable angina, or clinically significant cardiac arrhythmias.
• Have uncontrolled bleeding disorders.
• Have a history of allergic reactions attributed to compounds of similar biological composition to IL-12, aluminum hydroxide, or drugs formulated with polysorbate-20.
• Have other systemic conditions or organ abnormalities that may interfere with the conduct the current study.
• Have any acute or chronic psychiatric problems or substance abuse disorder that make the participant unsuitable for participation.

Sponsors & Collaborators

• Ankyra Therapeutics, Inc: lead

Study Officials

• Joe Elassal, MD, MBA

  Ankyra Therapeutics

  STUDY DIRECTOR

• Ann Silk, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gail Iodice, BSN, RN

CONTACT

347-882-1147; giodice@ankyratx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share