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NCT05084859 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors
A Phase 1 study, sponsored by Biosplice Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT05084859: Clinical Trial Phase 1 study, sponsored by Biosplice Therapeutics.
NCT05084859 is a Phase 1 study that was terminated before completion, run by Biosplice Therapeutics. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05084859, a Phase 1 study, was terminated before completion, sponsored by Biosplice Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study is an open-label, multi-center, dose-escalation, dose expansion study in adult subjects with advanced solid tumors. The study will evaluate the safety, tolerability, PK, and preliminary anti-tumor efficacy of SM08502 administered orally (PO), once daily (QD), following a 5 days on 2 days off treatment schedule in combination with chemotherapy or hormonal therapy. Alternative dosing schedules may be explored in Part 1 if necessary. The recommended Part 2 dose and schedule for each combination will then be further evaluated in the Part 2 expansion. Dosing will occur in 21- or 28-day cycles (depending on the combination partner) and treatment with SM08502 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.
Primary Outcome
As measured by NCI CTCAE version 5.0.
Interventions
- DRUG Docetaxel
- DRUG Prednisone
- DRUG Abiraterone
- DRUG FOLFIRI Protocol
- DRUG SM08502
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-11-03 |
| Est. Completion | 2022-10-20 |
| Phase | Phase 1 |
Why NCT05084859 stopped before completion
NCT05084859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.
NCT05084859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05084859 about?
NCT05084859 is a clinical study titled "A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors". This study is an open-label, multi-center, dose-escalation, dose expansion study in adult subjects with advanced solid tumors. The study will evaluate the safety, tolerability, PK, and preliminary anti-tumor efficacy of SM08502 administered orally (PO), once daily (QD), following a 5 days on 2 days ...
What is the current status of trial NCT05084859?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-11-03. Estimated completion is 2022-10-20.
What interventions are being tested in trial NCT05084859?
The interventions under investigation include: Docetaxel (DRUG), Prednisone (DRUG), Abiraterone (DRUG), FOLFIRI Protocol (DRUG), SM08502 (DRUG).
Who is sponsoring clinical trial NCT05084859?
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 NCT05084859's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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