Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors

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

Trial Details

NCT ID
NCT06171750
Phase
PHASE1
Sponsor
Ankyra Therapeutics, Inc
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • tolododekin alfa
  • Cemiplimab
Locations (sample)
  • Bethesda, Maryland, United States|38.98067,-77.10026
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Portland, Oregon, United States|45.52345,-122.67621
  • Pittsburgh, Pennsylvania, United States|40.44062,-79.99589
  • Toronto, Ontario, Canada|43.70643,-79.39864

Key Eligibility Criteria

  • ≥ 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 d…
  • 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 mali…
  • Part 3 CSCC Combination Cohort: Histologically confirmed high-risk locally advanced or metastatic CSCC not amenable to surgical management as deter…

For full eligibility, visit ClinicalTrials.gov.

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