Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of the open-label, dose-escalation study is to investigate the safety of single-dose monotherapy and repeated-dose of KHK2375 combined with exemestane in female subjects with advanced or recurrent breast cancer. The secondary objective is to investigate the pharmacokinetics and efficacy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.
• Treatments: Entinostat; Exemestane

Criteria

Inclusion Criteria:

• Postmenopausal women aged ≥ 20 and < 75 years at the time of consent;

• Estrogen receptor positive and/or progesterone receptors positive;

• HER2-negative

• Nonresectable advanced or recurrent breast cancer previously treated with nonsteroidal aromatase inhibitor (AI), and planning to be treated with exemestane

Exclusion Criteria:

• Radiation therapy or immuno therapy within 14 days before the first dose of investigational product;

• Chemotherapy, biological medicines, other pharmacotherapy or major surgery within 21 days before the first dose of the investigational product;

• Prior chemotherapies of ≥ 3 regimens for advanced or recurrent breast cancer;

• Ongoing treatment with other investigational product