Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Pleural Mesothelioma
• Intervention / Treatment: Drug: YS110

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: YS110; 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; Intravenous administration

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kissei Pharmaceutical Co., Ltd.
• Investigators: Study Director: Nobuo Kanai, Kissei Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 8, 2017
• Primary Completion (ACTUAL): February 5, 2020
• Study Completion (ACTUAL): February 5, 2020

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (ACTUAL): June 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Mesothelioma; Mesothelioma, Malignant
• Other Study ID Numbers: YS1101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No