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Life sciences · Phase 1 Trial
ClinicalTrials.gov · September 24, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT05384119). This is a study registration, not published results. Lead sponsor: Tvardi Therapeutics, Incorporated. Recruitment status: TERMINATED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 6 participants (ACTUAL). Conditions: Breast Cancer. Interventions: DRUG: TTI-101; DRUG: Palbociclib; DRUG: Aromatase inhibitor (AI); DRUG: fulvestrant; DRUG: ribociclib. Primary outcome measures: Phase 1b: Number of Participants Who Experience a Dose Limiting Toxicity (DLT) , Day 1 to Day 28; Phase 1b: Number of Participants Who Experience an Adverse Event (AE) , Up to approximately 17 months; Phase 1b: Number of Participants Who Experience a Serious Adverse Event (SAE) , Up to approximately 17 months; Phase 2: Landmark Progression Free Survival at 6 Months (PFS6) , 6 months. Brief 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.