Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Phase 1 Completed 33 enrolled Eisai Inc.

RandomizedSequentialOpen-labelTreatment

Summary

The purpose of study is to determine tolerability and safety profile of H3B-6545 in Japanese women with ER-positive, HER2-negative breast cancer, and also to confirm the dose applicability to Japanese.

Timeline

Start: 2020-09-30
Primary completion: 2025-10-01
Completion: 2025-10-01

Publications

Furman C, Puyang X, Zhang Z, Wu ZJ, Banka D, Aithal KB, Albacker LA, Hao MH, Irwin S, Kim A, Montesion M, Moriarty AD, Murugesan K, Nguyen TV, Rimkunas V, Sahmoud T, Wick MJ, Yao S, Zhang X, Zeng H, Vaillancourt FH, Bolduc DM, Larsen N, Zheng GZ, Prajapati S, Zhu P, Korpal M. Covalent ERalpha Antagonist H3B-6545 Demonstrates Encouraging Preclinical Activity in Therapy-Resistant Breast Cancer. Mol Cancer Ther. 2022 Jun 1;21(6):890-902. doi: 10.1158/1535-7163.MCT-21-0378.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	H3B-6545	Small molecule	300 mg	Oral
Subject	H3B-6545	Small molecule	450 mg	Oral
Background	Cetirizine	Other / unclassified	—	Oral
Background	Fexofenadine	Unknown	—	Oral
Background	Loratadine	Small molecule	—	Oral

Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Summary

Timeline

Publications

Drugs

Indications