Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Phase 1 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: KHK2375
* Drug: Exemestane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KHK2375 PO and Exemestane PO<br>KHK2375 and Exemestane | Drug: KHK2375<br>* KHK2375 will be orally administered once weekly. KHK2375 in combination with exemestane will be repeatedly administered in a 28-day cycle. Exemestane will be orally administered once daily.<br>Drug: Exemestane<br>* KHK2375 will be orally administered once weekly. KHK2375 in combination with exemestane will be repeatedly administered in a 28-day cycle. Exemestane will be orally administered once daily.<br>* Other names: SDNX-275;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage of subjects with treatment-emergent adverse events including dose-limiting toxicities and serious adverse events |  | Assessed up to 28 days after study discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of KHK2375 [maximum concentration (Cmax)] |  | Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1 | 
| Pharmacokinetics of KHK2375 [Area under the curve (AUC)] |  | Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1 | 
| Pharmacokinetics of KHK2375 [Half-life (t1/2)] |  | Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1 |