A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer

Summary

This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced and/or metastatic hormone receptor (HR)-positive, her2-negative breast cancer.

Timeline

Start

2020-08-13

Primary completion

2024-07-30

Completion

2024-07-30

Publications

• Hamilton EP, Patel MR, Borges VF, Meisel JL, Okera M, Alemany CA, Pluard TJ, Wesolowski R, Sabanathan D, Miller KD, Conlin AK, McCarthy N, Shaw M, Tonda M, Shilkrut M, Lin NU. Palazestrant, a novel oral Complete Estrogen Receptor Antagonist (CERAN) and Selective Estrogen Receptor Degrader (SERD), in patients with ER+/HER2- advanced or metastatic breast cancer: phase 1/2 study results. Breast Cancer Res. 2025 Jul 1;27(1):119. doi: 10.1186/s13058-025-02049-y.

Drugs

Indications