Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

Phase 1

Completed

• Conditions: Malignant Pleural Mesothelioma
• Interventions: Drug: YS110

• Registration Number: NCT03177668
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-06
• Study Start: 2017-08-08
• Primary Completion: 2020-02-05
• Study Completion: 2020-02-05
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-23
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
YS110	YS110	Phase 1 part: Administration of 3 different dose cohort Phase 2 part: Administration of recommended dose determined from result of Phase 1 part

Primary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Multiple Locations, Japan