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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Ankyra Therapeutics, Inc
Study ID
NCT06171750
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tolododekin alfa — DRUG
    IT administration of 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 of ANK-101.
  • Cemiplimab — DRUG
    Participants will receive four cycles of ANK-101 in combination with Cemiplimab. If there is no significant clinical deterioration as determined by the Investigator or unacceptable toxicity at Week 12, participants may receive an additional four cycles of the combination treatment. After stopping ANK-101 treatment, participants may stay on Cemiplimab monotherapy for an additional 24 weeks.

Study Details

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.

Key Dates

Start date
Jan 19, 2024
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
97 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: tolododekin alfa (ANK-101) IT Injection in Superficial Lesions
    IT injections of ANK-101 once every 3 weeks into superficial lesions
  • Experimental: tolododekin alfa (ANK-101) IT Injection in Visceral Lesions
    IT injections of ANK-101 once every 3 weeks into visceral lesions and every 6 weeks in the expansion
  • Experimental: tolododekin alfa (ANK-101) IT Injection in Combination with Cemiplimab
    IT injections of ANK-101 once every 3 weeks in combination with Cemiplimab into patients with high-risk locally advanced or metastatic CSCC that have superficial lesions

Primary Outcome Measure

Incidence and characteristics of DLTs (Parts 1 and 2 only) and TEAEs [ Time Frame: From Day 1 to 90 days after last injection of ANK-101 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
National Cancer InstituteBethesdaMaryland20892
Hoyoung Maeng, MD
[email protected]
240-781-3253
Massachusetts General HospitalBostonMassachusetts02114
Jong Park, MD
[email protected]
617-724-4000
Providence Cancer InstitutePortlandOregon97213
Brendan Curti, MD
[email protected]
Hillman Cancer CenterPittsburghPennsylvania15232
Danielle Bednarz, BS, RN
[email protected]
412-623-1191

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By research site
National Cancer Institute· Bethesda, MDMassachusetts General Hospital· Boston, MAProvidence Cancer Institute· Portland, ORHillman Cancer Center· Pittsburgh, PA

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