Cutaneous Squamous Cell Carcinoma (CSCC)Phase 1NCT07100925
A Study of Tolododekin Alfa (ANK-101) in Renal Allograft Recipients With High Risk Cutaneous Squamous Cell Carcinoma
A Phase 1 study testing tolododekin alfa in people with Cutaneous Squamous Cell Carcinoma (CSCC) and Renal Transplant, run by Ankyra Therapeutics, Inc.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma (CSCC), Renal Transplant, Solid Tumor
- What is being tested?
- tolododekin alfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to Dec 2030
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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).
- Conditions
- Cutaneous Squamous Cell Carcinoma (CSCC), Renal Transplant, Solid Tumor, Solid Tumor Cancer
- Being tested
- tolododekin alfa
- Keywords
- intratumoral injection, intratumoral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tolododekin alfaDrug
IT administration of ANK-101 once every 3 weeks for 2 cycles, followed by surgical resection
| Study group | Role | What they receive |
|---|---|---|
| tolododekin alfa (ANK-101) IT Injection | Experimental | Participants will receive 2 cycles of tolododekin alfa before surgical resection of CSCC tumor Receives: Drug: tolododekin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
Event Free Survival (EFS)
Time from the first dose of tolododekin alfa to date of event
Measured: Up to 3 years
Relapse Free Survival (RFS)
Time from surgical resection to the earliest date of relapse or death from any cause.
Measured: Up to 3 years
Pathological Complete Response (pCR)
The percentage of participants with complete absence of viable cancer cells in the surgical pathology sample among all response evaluable participants.
Measured: 3 months
Best Overall Response Rate (BORR)
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.
Measured: Up to 3 years
Overall Survival (OS)
The time from the administration of tolododekin alfa to death from any cause
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start15 Dec 2025 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionDec 2030 (estimated)
Why it stopped: Strategic realignment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell Carcinoma (CSCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankyra Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joe Elassal, MD, MBA, Study director, Ankyra TherapeuticsAnn Silk, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100925
- Sponsor's protocol ID
- ANK-101-003
- Status last verified
- Jun 2026
- First submitted
- 28 Jul 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Tolododekin Alfa (ANK-101) in Renal Allograft Recipients With Resectable, High-Risk Cutaneous Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07100925
- Acronym / sponsor ID
- ANK-101-003
- Conditions
- Cutaneous Squamous Cell Carcinoma (CSCC), Renal Transplant, Solid Tumor, Solid Tumor Cancer
- Keywords
- intratumoral injection, intratumoral
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic realignment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ankyra Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tolododekin alfa (ANK-101) IT Injection | Experimental | Drug: tolododekin alfaParticipants will receive 2 cycles of tolododekin alfa before surgical resection of CSCC tumor |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tolododekin alfaIT administration of ANK-101 once every 3 weeks for 2 cycles, followed by surgical resection | Drug | tolododekin alfa (ANK-101) IT Injection |
Primary outcome
Major Pathological Response (MPR) rate
Time frame: 3 months
The percentage of participants who have ≤ 10% viable cancer cells in the surgical pathology sample among all response evaluable participants.
5 secondary outcomes
Event Free Survival (EFS)
Time frame: Up to 3 years
Relapse Free Survival (RFS)
Time frame: Up to 3 years
Pathological Complete Response (pCR)
Time frame: 3 months
Best Overall Response Rate (BORR)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe Elassal, MD, MBA study director
Ankyra Therapeutics
Ann Silk, MD principal investigator
Dana-Farber Cancer Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tolododekin alfa in people with Cutaneous Squamous Cell Carcinoma (CSCC) and Renal Transplant, run by Ankyra Therapeutics, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response (MPR) rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.