Phase 1 Tolododekin Alfa for Advanced Solid Tumors
This study is testing a new treatment called tolododekin alfa (ANK-101) for people with advanced solid tumors that have spread or are difficult to treat. It's a Phase 1 study, which means the main goal is to find out if the treatment is safe and what dose works best. Some participants will receive tolododekin alfa by itself, injected directly into the tumor. Others will receive tolododekin alfa combined with another medicine called cemiplimab. You might be able to join if you are at least 18 years old and have certain types of advanced solid tumors. The study aims to enroll 97 participants. We are looking for people whose cancer has progressed after standard treatments or who cannot benefit from them.
- Study design
- This is a Phase 1, open-label study, meaning you and your doctors will know which treatment you are receiving. It is designed to test different doses of tolododekin alfa, alone or in combination with cemiplimab, in up to 97 participants.
- What's involved
- You would receive injections of tolododekin alfa every three weeks for up to 12 weeks, with a possibility of more doses if your condition remains stable. If you are in the combination group, you would also receive cemiplimab.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for 90 days after your last injection of tolododekin alfa. The study will also look at how well the treatment works for approximately 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06171750
Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentAnkyra Therapeutics, Inc
~97 participants
Updated 2026-03-06 on ClinicalTrials.gov
What's tested:tolododekin alfaCemiplimab
At a glance
Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and characteristics of DLTs (Parts 1 and 2 only) and TEAEs
Measured over From Day 1 to 90 days after last injection of ANK-101
+2 more outcomes measured
Conditions
Where it's being run
5 sites across 5 statesMaryland1
Massachusetts1
Oregon1
Pennsylvania1
Ontario1
Study leadership
- Joseph Elassal, MD, MBA · STUDY_DIRECTOR · Ankyra Therapeutics, Inc
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
≥ 18 years of age on day of signing informed consent
histologically or cytologically confirmed diagnosis of cutaneous, subcutaneous, soft tissue, or nodal advanced solid tumor malignancy; metastatic disease eligible
measurable disease per RECIST v1.1 - Note: Must have at least 1 tumor lesion with longest dimension of ≥ 10 mm (≥ 15 mm for the short axis for malignant lymph node lesions) that - For Part 1 only: can be easily palpated or detected by ultrasound to facilitate IT injection of ANK-101 (i.e., tumor in skin, muscle, subcutaneous tissue, or accessible lymph node) or; - For Part 2 only: can be accessed by interventional radiologic or endoscopic procedures for injection (e.g., ultrasound or computed tomography \[CT\] guided). - For Part 2 Dose Expansion Cohort only: Histologically confirmed Stage III or Stage IV NSCLC
Part 3 CSCC Combination Cohort: Histologically confirmed high-risk locally advanced or metastatic CSCC not amenable to surgical management as determined by a multidisciplinary tumor board.
documented disease progression, be refractory to, or intolerant of existing SOC therapy(ies) known to provide clinical benefit (including surgical cure) or not be eligible for SOC therapy(ies)
ECOG performance status 0-1
life expectancy \> 12 weeks
adequate bone marrow, hepatic and renal function
baseline electrocardiogram (EKG) without evidence of acute ischemia or prolonged QTc interval \> 460 msec
Human immunodeficiency virus (HIV) infected participants must be on anti-retroviral therapy (ART) and have well-controlled HIV infection/disease
last dose of previous anticancer therapy (including investigational agents) ≥ 28 days, radiotherapy ≥ 14 days (targeted palliative radiotherapy is allowed for lesions not planned for injections), or surgical intervention ≥ 21 days prior to the start of treatment
resolution of all prior anticancer therapy toxicities (except for alopecia or vitiligo) to ≤ Grade 1 (as per NCI CTCAE Version 5.0)
willing to provide pre- and post-treatment tumor biopsy samples if medically feasible
participant is capable of understanding and complying with protocol requirements
Exclusion
injectable tumors impinging upon major airways or blood vessels
prior treatment with recombinant interleukin-12 (IL-12)
have received systemic therapy with immunosuppressive agents ≤ 28 days before the start of treatment
have received live vaccines within 28 days prior to the start of ANK-101 treatment
have primary or acquired immunodeficient states (e.g., leukemia, lymphoma)
a woman of childbearing potential (WOCBP) who has a positive serum pregnancy test (within 72 hours) prior to the start of treatment or female participant who is breastfeeding
prior organ transplantation
known history of hepatitis B virus, known active hepatitis C virus, or a positive serological test at screening within 28 days prior to the start of treatment
HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
active autoimmune disease or medical conditions requiring chronic steroid (i.e., ≥ 20 mg/day prednisone or equivalent) or other immunosuppressive therapy within 28 days prior to the start of treatment
known active central nervous system (CNS) metastases
congestive heart failure (\> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest), or clinically significant cardiac arrhythmias
uncontrolled bleeding disorders within 4 weeks prior to the start of treatment or known bleeding diathesis - Note: Part 2 only: Participants with active bleeding diathesis or requirement for therapeutic anticoagulation that cannot be interrupted or altered for procedures
history of hypersensitivity to compounds of similar biological composition to IL-12, aluminum hydroxide, or drugs formulated with polysorbate-20
other systemic conditions or organ abnormalities that, in the opinion of the Investigator, may interfere with the conduct and/or interpretation of the current study
any acute or chronic psychiatric problems or substance abuse disorder that, in the opinion of the Investigator, make the participant unsuitable for participation
Part 3 only: prior Grade 3 or greater immune-mediated adverse events (imAEs) following treatment with an agent that blocks the programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) pathway.
Part 3 only: hypersensitivity to cemiplimab or any of its excipients or contraindications to cemiplimab per approved local labeling
What this trial measures
- Incidence and characteristics of DLTs (Parts 1 and 2 only) and TEAEsFrom Day 1 to 90 days after last injection of ANK-101
Number and percentage of participants reporting each DLT or TEAE.
- RDE of ANK-101Approximately 12 months
Defined based on the rate of DLTs and TEAEs
- Incidence and characteristics of TEAEs of ANK-101 in combination with Cemiplimab according to NCI CTCAE v5.0 (Part 3 only)From Day 1 to 90 days after last injection of ANK-101 in combination with Cemiplimab.
Number and percentage of participants reporting each TEAE.