Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

• Status: Completed
• Trial end date: 2020-02-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine tolerability, safety, and pharmacokinetics of YS110 intravenous administration in patients with malignant pleural mesothelioma and to preliminarily examine the anti-tumor effect of YS110.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• Patient with male or female aged ≥ 20 (and aged < 75 in Phase 1 part)

• Patients whose malignant pleural mesothelioma was histologically confirmed

• Patients who have advanced pleural mesothelioma that are refractory to existing anti-tumor drugs and who have no other standard therapies which should be prioritized

• Patients whose most recent major surgery (except exploratory thoracotomy or laparotomy) or drug or radiation therapy for malignant tumors, if any, was at least 4 weeks ago (at least 12 weeks ago for immunotherapy) at the subject enrollment

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1 or less

Exclusion Criteria:

• Patients whose toxicity findings in the previous treatment (antineoplastic agents) have not been yet restored

• Patients with tumor lesions in central nervous system confirmed in MRI or CT