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NCT05388435 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients
A Phase 1 study, sponsored by SK Life Science.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT05388435: Clinical Trial Phase 1 study, sponsored by SK Life Science.
NCT05388435 is a Phase 1 study that was terminated before completion, run by SK Life Science. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05388435, a Phase 1 study, was terminated before completion, sponsored by SK Life Science.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
Primary Objective of Part 1 (Dose Escalation Phase): Evaluate the safety and tolerability of SKL27969, and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of SKL27969 Primary Objective of Part 2 (Dose Expansion Phase): Evaluate the preliminary anti-tumor activity of SKL27969
Primary Outcome
Any incidence of AEs, dose interruptions and dose modifications from signing of Informed Consent Form (ICF) until discontinuation and/or protocol required Survival Follow-up is completed.
Interventions
- DRUG SKL27969
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-09-12 |
| Est. Completion | 2024-03-01 |
| Phase | Phase 1 |
Why NCT05388435 stopped before completion
NCT05388435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which SKL27969 is the first listed.
NCT05388435 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05388435 about?
NCT05388435 is a clinical study titled "Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients". Primary Objective of Part 1 (Dose Escalation Phase): Evaluate the safety and tolerability of SKL27969, and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of SKL27969 Primary Objective of Part 2 (Dose Expansion Phase): Evaluate the preliminary anti-tumor activity o...
What is the current status of trial NCT05388435?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2022-09-12. Estimated completion is 2024-03-01.
What interventions are being tested in trial NCT05388435?
The interventions under investigation include: SKL27969 (DRUG).
Who is sponsoring clinical trial NCT05388435?
This trial is sponsored by SK Life Science, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05388435's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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