Overview

Study of TTI-101 in Combination for Participants With Metastatic Hormone Receptor-Positive and Human Epithelial Receptor 2 (HER2)-Negative Breast Cancer

Status:
Not yet recruiting

Trial end date:
2025-02-01

Target enrollment:

Participant gender:

Summary

The primary objectives of the Phase 1b part of this study are to evaluate the safety and tolerability of TTI-101 when added to palbociclib and aromatase inhibitor (AI) administered orally to participants with estrogen receptor-positive (ER+) human epithelial 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. The primary objective of the Phase 2 part of this study is to evaluate tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria in participants who receive TTI-101 added to palbociclib and AI.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Tvardi Therapeutics, Incorporated

Treatments:

Aromatase Inhibitors
Palbociclib