NCT05384119

Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer

REVERT- Breast Cancer: Phase 1b/2 Study of the Addition of STAT3 Inhibitor TTI-101 to Reverse Resistance to Palbociclib or Ribociclib Plus Aromatase Inhibitor or Fulvestrant Therapy for Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Tvardi Therapeutics, Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	TTI-101	Oral tablet
DRUG	Palbociclib	Oral capsule
DRUG	Aromatase inhibitor (AI)	Oral tablet
DRUG	fulvestrant	Oral tablet
DRUG	ribociclib	Oral tablet

Timeline

• Start date: 2023-01-09
• Primary completion: 2024-04-25
• Completion: 2024-04-25
• First posted: 2022-05-20
• Last updated: 2025-02-21

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study