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NCT05384119 · ClinicalTrials.gov registry record · Phase 1
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
A Phase 1 study, sponsored by Tvardi Therapeutics, Incorporated.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT05384119: Clinical Trial Phase 1 study, sponsored by Tvardi Therapeutics, Incorporated.
NCT05384119 is a Phase 1 study that was terminated before completion, run by Tvardi Therapeutics, Incorporated. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05384119, a Phase 1 study, was terminated before completion, sponsored by Tvardi Therapeutics, Incorporated.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal receptor 2-negative (HER2)- palbociclib-resistant breast cancer, and to determine the recommended Phase 2 dose (RP2D) for TTI-101 when added to palbociclib and AI or fulvestrant. The primary objective of Phase 2 will be to evaluate anti-tumor activity in participants who receive TTI-101 added to palbociclib or ribociclib and AI or fulvestrant.
Interventions
- DRUG Palbociclib
- DRUG ribociclib
- DRUG fulvestrant
- DRUG TTI-101
- DRUG Aromatase inhibitor (AI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2023-01-09 |
| Est. Completion | 2024-04-25 |
| Phase | Phase 1 |
Why NCT05384119 stopped before completion
NCT05384119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which Palbociclib is the first listed.
NCT05384119 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05384119 about?
NCT05384119 is a clinical study titled "Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer". The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal receptor 2-negative (HER2)- palbociclib-resistant breast cancer, and t...
What is the current status of trial NCT05384119?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2023-01-09. Estimated completion is 2024-04-25.
What interventions are being tested in trial NCT05384119?
The interventions under investigation include: Palbociclib (DRUG), ribociclib (DRUG), fulvestrant (DRUG), TTI-101 (DRUG), Aromatase inhibitor (AI) (DRUG).
Who is sponsoring clinical trial NCT05384119?
This trial is sponsored by Tvardi Therapeutics, Incorporated, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05384119's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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