OncoMatch/Clinical Trials/NCT06171750
Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors
Is NCT06171750 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including tolododekin alfa and Cemiplimab for advanced solid tumor.
Treatment: tolododekin alfa · Cemiplimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Small Cell Lung Cancer
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard of care therapy
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)
Cannot have received: recombinant interleukin-12
prior treatment with recombinant interleukin-12 (IL-12)
Cannot have received: immunosuppressive agents
have received systemic therapy with immunosuppressive agents ≤ 28 days before the start of treatment
Cannot have received: live vaccines
have received live vaccines within 28 days prior to the start of ANK-101 treatment
Cannot have received: anti-PD-1/PD-L1 therapy
Exception: 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: 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
Lab requirements
Blood counts
adequate bone marrow function
Kidney function
adequate renal function
Liver function
adequate hepatic function
Cardiac function
baseline electrocardiogram (EKG) without evidence of acute ischemia or prolonged QTc interval > 460 msec
adequate bone marrow, hepatic and renal function; baseline electrocardiogram (EKG) without evidence of acute ischemia or prolonged QTc interval > 460 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Cancer Institute · Bethesda, Maryland
- Massachusetts General Hospital · Boston, Massachusetts
- Providence Cancer Institute · Portland, Oregon
- Hillman Cancer Center · Pittsburgh, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify