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NCT03355066 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors
A Phase 1 study, sponsored by Biosplice Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
NCT03355066: Clinical Trial Phase 1 study, sponsored by Biosplice Therapeutics.
NCT03355066 is a Phase 1 study that was terminated before completion, run by Biosplice Therapeutics. The registered enrollment target is 82 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03355066, a Phase 1 study, was terminated before completion, sponsored by Biosplice Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 82 participants
- Enrollment target
Study Summary
This study is an open-label, multi-center, dose-escalation, dose-finding and expansion study in adult subjects with advanced solid tumors for whom no standard therapy is available. The study will evaluate the safety, tolerability, PK, PD, and preliminary anti-tumor efficacy of SM08502 administered orally, once daily, following a 28-day treatment cycle (Part 1A). Alternative dosing schedules will be explored in Part 1B and the recommended Part 2 dose and schedule will be further evaluated in Part 2. Subjects will participate in a screening period of up to 14 days. Dosing in 28-day cycles will continue within each subject, unless treatment is discontinued due to toxicity, disease progression, initiation of a new anti-neoplastic therapy, withdrawal of consent, the Sponsor terminates the study, or the subject no longer meets retreatment criteria. Approximately 10 subjects enrolled in Part 2, irrespective of the tumor type, will be included in a food effect substudy to assess the preliminary effect of a high-fat, high-calorie meal on the PK of SM08502. Subjects participating in the food effect substudy will continue on study and complete assessments as per the Part 2 schedule and receive SM08502 at the recommended Part 2 dose (or another previously assessed dose level and schedule).
Interventions
- DRUG SM08502
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2017-11-06 |
| Est. Completion | 2022-11-14 |
| Phase | Phase 1 |
Why NCT03355066 stopped before completion
NCT03355066 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 1 intervention - of which SM08502 is the first listed.
NCT03355066 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03355066 about?
NCT03355066 is a clinical study titled "A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors". This study is an open-label, multi-center, dose-escalation, dose-finding and expansion study in adult subjects with advanced solid tumors for whom no standard therapy is available. The study will evaluate the safety, tolerability, PK, PD, and preliminary anti-tumor efficacy of SM08502 administered o...
What is the current status of trial NCT03355066?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2017-11-06. Estimated completion is 2022-11-14.
What interventions are being tested in trial NCT03355066?
The interventions under investigation include: SM08502 (DRUG).
Who is sponsoring clinical trial NCT03355066?
This trial is sponsored by Biosplice Therapeutics, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03355066's enrollment target sits among peer trials
82 669th of 2000 higher than 1,330 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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