Interleukin-12 anchored drug conjugate (tolododekin alfa) in patients with advanced solid tumors: first-in-human Phase 1 trial.
Jong Chul Park, Brendan Curti, Marcus Butler...
https://pubmed.ncbi.nlm.nih.gov/41022754Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID06171750
Phase I Open-Label Dose Escalation Study of Tolododekin Alfa (ANK-101) Safety and Tolerability in Advanced Solid Tumors including Combination with Cemiplimab
Led by Ankyra Therapeutics, Inc · Updated on 2026-03-06
97
Participants Needed
5
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of tolododekin alfa (ANK-101) injected directly into tumors in adults with advanced solid tumors who have not responded to standard treatments or cannot benefit from them. This Phase 1, open-label, dose escalation study aims to determine the best dose of ANK-101 and its effects alone or combined with cemiplimab in different types of tumors, including superficial, visceral, and cutaneous squamous cell carcinoma (CSCC). The study is divided into three parts. In Part 1, participants with accessible superficial tumors receive ANK-101 injections every three weeks. Part 2 enrolls participants with visceral tumors receiving ANK-101 injections with a dose expansion cohort for non-small cell lung cancer (NSCLC). Part 3 involves combining ANK-101 with cemiplimab every three weeks for participants with high-risk locally advanced or metastatic CSCC. Participants may receive additional doses or cemiplimab monotherapy after completing the combination treatment phase. Participants undergo tumor biopsies when possible and are closely monitored for side effects, dose-limiting toxicities, and treatment responses. Safety assessments occur from the first dose through 90 days after the last injection. Pharmacokinetic and clinical activity measurements continue for up to two years. The study duration varies by participant depending on treatment response and tolerance, with assessments including physical exams, laboratory tests, and imaging to evaluate tumor changes and overall health.
CONDITIONS
Brief Title
Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years of age or older on the 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 with at least one tumor lesion accessible for intratumoral injection
- For Part 2 Dose Expansion Cohort only: Histologically confirmed Stage III or Stage IV non-small cell lung cancer (NSCLC)
- For Part 3 Combination Cohort: Histologically confirmed high-risk locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) not suitable for surgery
- Documented progression, refractory or intolerance to existing standard of care therapies, or ineligibility for such therapies
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy greater than 12 weeks
- Adequate bone marrow, liver, and kidney function
- Baseline electrocardiogram without acute ischemia or prolonged QTc interval > 460 msec
- HIV-infected participants must be on antiretroviral therapy with well-controlled disease
- Adequate time since last anticancer therapy or surgical intervention per protocol
- Resolution of prior anticancer therapy toxicities to Grade 1 or less (except alopecia or vitiligo)
- Willingness to provide pre- and post-treatment tumor biopsy samples if feasible
- Ability to understand and comply with study requirements
You will not qualify if you...
- Tumors located near major airways or blood vessels that prevent safe intratumoral injection
- Prior treatment with recombinant interleukin-12 (IL-12)
- Use of systemic immunosuppressive agents within 28 days prior to treatment
- Receipt of live vaccines within 28 days before starting treatment
- Primary or acquired immunodeficiency conditions (e.g., leukemia, lymphoma)
- Positive pregnancy test within 72 hours before treatment or breastfeeding female participants
- Prior organ transplantation
- Known active or recent hepatitis B or C infection
- HIV-infected participants with history of Kaposi sarcoma or Multicentric Castleman Disease
- Active autoimmune disease or need for chronic high-dose steroids or immunosuppressants within 28 days before treatment
- Active central nervous system metastases
- Significant heart conditions including congestive heart failure above Class II, recent unstable angina, or serious arrhythmias
- Uncontrolled bleeding disorders or bleeding risk that cannot be managed (Part 2 only)
- Allergy or hypersensitivity to IL-12, aluminum hydroxide, polysorbate-20, or similar compounds
- Other systemic illnesses or organ problems interfering with study conduct
- Acute or chronic psychiatric or substance abuse disorders preventing participation
- Part 3 only: Prior severe immune-related adverse events from PD-1/PD-L1 inhibitors
- Part 3 only: Allergy or contraindications to cemiplimab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 24 weeks for tolododekin alfa alone; up to 36 weeks including cemiplimab monotherapy
Participants receive intratumoral injections of tolododekin alfa (ANK-101) once every 3 weeks for up to 12 weeks (4 doses). If there is no disease progression, decrease in clinical performance status, or unacceptable toxicity, participants may receive 4 additional doses. In the combination cohort, participants receive ANK-101 injections with cemiplimab every 3 weeks for four cycles, with the possibility of 4 additional cycles and further cemiplimab monotherapy for 24 weeks after stopping ANK-101.
Visits every 3 weeks during treatment cycles
Follow-up
Duration - 90 days
Participants are monitored for safety and treatment effects for 90 days after the last injection of tolododekin alfa or the combination with cemiplimab.
Multiple visits during 90-day follow-up period
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
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Research Team
G
Gail Iodice, BSN, RN
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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