Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

Kissei

Status and phase: Completed; Phase 2; Phase 1

Conditions: Malignant Pleural Mesothelioma

Treatments: Drug: YS110

Study type: Interventional

Funder types: Industry

Identifiers

NCT03177668

YS1101

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

YS110

Experimental group

Description:

Phase 1 part: Administration of 3 different dose cohort Phase 2 part: Administration of recommended dose determined from result of Phase 1 part

Treatment:

Drug: YS110