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NCT05432193 · ClinicalTrials.gov registry record · Phase 1
FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients With Select Solid Tumors (FRONTIER)
A Phase 1 study, sponsored by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT05432193: Clinical Trial Phase 1 study, sponsored by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company.
NCT05432193 is a Phase 1 study that was terminated before completion, run by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05432193, a Phase 1 study, was terminated before completion, sponsored by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This Phase 1 study will evaluate the safety and tolerability of \[Ga-68\]-PNT6555 and \[Lu-177\]-PNT6555 in subjects with select solid tumors that have FAP over-expression, in order to determine a recommended Phase 2 dose.
Primary Outcome
Occurrence of Treatment emergent adverse events as per CTCAE v5.0
Interventions
- DRUG [Ga-68]-PNT6555
- DRUG [Lu-177]-PNT6555
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-07-13 |
| Est. Completion | 2024-10-02 |
| Phase | Phase 1 |
Why NCT05432193 stopped before completion
NCT05432193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which [Ga-68]-PNT6555 is the first listed.
NCT05432193 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05432193 about?
NCT05432193 is a clinical study titled "FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients With Select Solid Tumors (FRONTIER)". This Phase 1 study will evaluate the safety and tolerability of \[Ga-68\]-PNT6555 and \[Lu-177\]-PNT6555 in subjects with select solid tumors that have FAP over-expression, in order to determine a recommended Phase 2 dose.
What is the current status of trial NCT05432193?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2022-07-13. Estimated completion is 2024-10-02.
What interventions are being tested in trial NCT05432193?
The interventions under investigation include: [Ga-68]-PNT6555 (DRUG), [Lu-177]-PNT6555 (DRUG).
Who is sponsoring clinical trial NCT05432193?
This trial is sponsored by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05432193's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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