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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 is a Phase 1 study that was terminated before completion, run by Tvardi Therapeutics, Incorporated. The registered enrollment target is 6 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05384119
The ClinicalTrials.gov registry entry for NCT05384119 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tvardi Therapeutics, Incorporated, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Palbociclib is the first listed.
NCT05384119 reports 0 study locations.
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.
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