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NCT06171750 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor, sponsored by Ankyra Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 97
- Enrollment target
- 5
- Study locations
NCT06171750: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor, sponsored by Ankyra Therapeutics.
NCT06171750 is a Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor that is actively recruiting participants, run by Ankyra Therapeutics. The registered enrollment target is 97 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06171750, a Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor, is actively recruiting participants, sponsored by Ankyra Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 97 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Primary Outcome
Number and percentage of participants reporting each DLT or TEAE.
Conditions Studied
Interventions
- DRUG Cemiplimab
- DRUG tolododekin alfa
Study Locations (5)
Maryland
- National Cancer Institute - Bethesda
Massachusetts
- Massachusetts General Hospital - Boston
Oregon
- Providence Cancer Institute - Portland
Pennsylvania
- Hillman Cancer Center - Pittsburgh
Ontario
- Princess Margaret Cancer Centre - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2024-01-19 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
What NCT06171750 shows while recruiting
NCT06171750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower).
The record links to 9 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Cemiplimab is the first listed.
NCT06171750 lists 5 locations in 5 states (Maryland, Massachusetts, Oregon).
Frequently Asked Questions
What is clinical trial NCT06171750 about?
NCT06171750 is a clinical study titled "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 n...
What is the current status of trial NCT06171750?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2024-01-19. Estimated completion is 2027-06.
What conditions does trial NCT06171750 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Solid Tumor, Advanced Solid Tumor, Metastatic Solid Tumor, Cutaneous Squamous Cell Carcinoma.
What interventions are being tested in trial NCT06171750?
The interventions under investigation include: Cemiplimab (DRUG), tolododekin alfa (DRUG).
Who is sponsoring clinical trial NCT06171750?
This trial is sponsored by Ankyra Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06171750 being conducted?
This trial has 5 study locations across Maryland, Massachusetts, Oregon, Pennsylvania, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06171750's enrollment target sits among peer trials
97 248th of 454 higher than 207 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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