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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 is a Phase 1 study that was terminated before completion, run by Biosplice Therapeutics. The registered enrollment target is 82 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03355066
The ClinicalTrials.gov registry entry for NCT03355066 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biosplice Therapeutics, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SM08502 is the first listed.
NCT03355066 reports 0 study locations.
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.
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