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NCT05963997 · ClinicalTrials.gov registry record · Phase 1
A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer
A Phase 1 study, sponsored by Carrick Therapeutics Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT05963997: Completed Phase 1 study, sponsored by Carrick Therapeutics Limited.
NCT05963997 is a Phase 1 study that has completed, run by Carrick Therapeutics Limited. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05963997, a Phase 1 study, has completed, sponsored by Carrick Therapeutics Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.
Primary Outcome
Identification of Samuraciclib + Elacestrant combination, Phase 2, expansion dose level. Incidence and severity of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse events (NCI-CTCAE) v5.0. Safety will be assessed by monitoring treatment - emerged severe and dose limiting adverse events and clinically relevant changes in vital signs and clinical laboratory results
Interventions
- DRUG Samuraciclib
- DRUG Elacestrant Dihydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2023-10-09 |
| Est. Completion | 2026-03-06 |
| Phase | Phase 1 |
What the finished NCT05963997 record still lists
NCT05963997 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Samuraciclib is the first listed.
NCT05963997 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05963997 about?
NCT05963997 is a clinical study titled "A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer". This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast...
What is the current status of trial NCT05963997?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2023-10-09. Estimated completion is 2026-03-06.
What interventions are being tested in trial NCT05963997?
The interventions under investigation include: Samuraciclib (DRUG), Elacestrant Dihydrochloride (DRUG).
Who is sponsoring clinical trial NCT05963997?
This trial is sponsored by Carrick Therapeutics Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05963997's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 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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