Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

Study Overview
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Brief Summary
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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.

Official Title
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Phase I/II Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

Conditions
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Malignant Pleural Mesothelioma

Intervention / Treatment
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* Drug: YS110


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

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: YS110<br>Phase 1 part: Administration of 3 different dose cohort Phase 2 part: Administration of recommended dose determined from result of Phase 1 part | Drug: YS110<br>* Intravenous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Status of onset of Dose Limiting Toxicity (DLT) | Assessed by number of subjects with DLT of YS110 | 18 days | 
| Disease Control Rate (DCR) | The proportion of subjects with assessed overall response as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) | 6 months | 
| Progression Free Survival (PFS) | The period from the starting day of the administration to Progressive Disease (PD) or death | Assessed for duration of study participation which is estimated to be 18 months | 
| Response Rate (RR) | The proportion of subjects with assessed the best overall response as CR or PR | Assessed for duration of study participation which is estimated to be 18 months | 
| Overall Survival (OS) | The period from the starting day of the administration to death | Assessed for duration of study participation which is estimated to be 18 months | 
| LCSS-Meso | Assessed for Quality of life (QOL) by using the modified Lung Cancer Symptom Scale for mesothelioma | Assessed for duration of study participation which is estimated to be 18 months | 
| EORTC QLQ-C30 | Assessed for QOL by using the Japanese versions of EORTC QLQ-C30 in the cancer patients | Assessed for duration of study participation which is estimated to be 18 months |