Actively Recruiting
Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors
Led by Ankyra Therapeutics, Inc · Updated on 2026-03-06
97
Participants Needed
5
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1, multicenter, open-label dose escalation study to determine the safety and tolerability of intratumoral (IT) injection of tolododekin alfa (ANK-101) in participants with advanced solid tumors who have progressed during or after receiving standard of care (SOC) therapy or who will not benefit from such therapy. The study will be conducted in three parts; in Part 1, participants with superficial lesions will receive ANK-101 as a single agent; in Part 2, participants with visceral lesions will receive ANK-101 as a single agent; and in Part 3, participants with cutaneous squamous cell carcinoma (CSCC) will receive ANK-101 in combination with cemiplimab.
CONDITIONS
Official Title
Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of consent
- Histologically or cytologically confirmed advanced solid tumor malignancy including cutaneous, subcutaneous, soft tissue, or nodal tumors; metastatic disease allowed
- Measurable tumor lesion per RECIST v1.1 with longest dimension ≥10 mm (≥15 mm for short axis of malignant lymph nodes)
- For Part 1: lesion easily palpable or detectable by ultrasound for injection
- For Part 2: lesion accessible by interventional radiology or endoscopic procedures for injection
- For Part 2 Dose Expansion Cohort: histologically confirmed Stage III or IV non-small cell lung cancer
- For Part 3 CSCC Combination Cohort: histologically confirmed high-risk locally advanced or metastatic cutaneous squamous cell carcinoma not suitable for surgery
- Documented disease progression, refractory or intolerant to standard of care therapy or ineligible for such therapy
- ECOG performance status of 0 or 1
- Life expectancy greater than 12 weeks
- Adequate bone marrow, liver, and kidney function
- Baseline EKG without acute ischemia or prolonged QTc interval >460 msec
- HIV-infected participants must be on antiretroviral therapy with well-controlled infection
- Last anticancer therapy dose at least 28 days prior; radiotherapy at least 14 days prior (palliative radiotherapy allowed for non-injected lesions); surgery at least 21 days prior
- Resolution of prior anticancer therapy toxicities to Grade 1 or less (except alopecia or vitiligo)
- Willingness to provide pre- and post-treatment tumor biopsies if medically feasible
- Ability to understand and comply with study requirements
You will not qualify if you...
- Tumors injectable but impinging on major airways or blood vessels
- Prior treatment with recombinant interleukin-12
- Systemic immunosuppressive therapy within 28 days before treatment start
- Live vaccines within 28 days before treatment start
- Primary or acquired immunodeficiency conditions such as leukemia or lymphoma
- Women of childbearing potential with positive pregnancy test or breastfeeding
- Prior organ transplantation
- Known active hepatitis B or C infection or positive serology within 28 days before treatment
- HIV-infected participants with history of Kaposi sarcoma or Multicentric Castleman Disease
- Active autoimmune diseases or requiring chronic steroids or immunosuppressants within 28 days before treatment
- Known active central nervous system metastases
- Congestive heart failure greater than NYHA Class II, active coronary artery disease, recent or unstable angina, or significant arrhythmias
- Uncontrolled bleeding disorders within 4 weeks before treatment or bleeding diathesis (Part 2 only: requiring anticoagulation that cannot be altered)
- History of hypersensitivity to IL-12, aluminum hydroxide, or polysorbate-20 containing drugs
- Other systemic conditions or organ problems interfering with study conduct
- Acute or chronic psychiatric or substance abuse disorders making participation unsuitable
- Part 3 only: prior Grade 3 or higher immune-related adverse events from PD-1/PD-L1 blockers
- Part 3 only: hypersensitivity or contraindications to cemiplimab as per labeling
AI-Screening
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Trial Site Locations
Total: 5 locations
1
National Cancer Institute
Bethesda, Maryland, United States, 20892
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Providence Cancer Institute
Portland, Oregon, United States, 97213
Actively Recruiting
4
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
5
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
G
Gail Iodice, BSN, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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