Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

Kissei Pharmaceutical Co., Ltd.40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Pleural Mesothelioma

Interventions

YS110DRUG

Intravenous administration

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Multiple Locations, Japan

Outcomes

Primary Outcomes

Status of onset of Dose Limiting Toxicity (DLT)

Assessed by number of subjects with DLT of YS110

Time frame: 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)

Time frame: 6 months

Progression Free Survival (PFS)

The period from the starting day of the administration to Progressive Disease (PD) or death