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Phase 1b/2 Study of the Addition of STAT3 Inhibitor TTI-101 to Reverse Resistance on First- Line Palbociclib Plus Aromatase Inhibitor Therapy for Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer

  • Protocol Number: 202206049
  • Principal Investigator: Ma, Cynthia
  • Cancer Types: Breast

Learn more about this study at: clinicaltrials.gov

For more information on this trial, contact us here:

Phone
800-600-3606
Email
info@ccadmin.wustl.edu

Brief 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 hormone receptor-positive (HR+) 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.

Protocol Interventions

TTI-101, Palbociclib, Aromatase inhibitor (AI)