Two-Part, Open-Label, Multi-Center, Phase 1/2 Study of BIW-8962 as Monotherapy in Subjects With Lung Cancer

NCT ID: NCT01898156

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-06-30

Brief Summary

This Phase 1/2 study is designed to assess the following: safety and tolerability of BIW-8962, Dose Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D) in Phase 1 in subjects with advanced/recurrent lung cancers or mesothelioma and preliminary efficacy in Phase 2 in subjects with advanced/recurrent Small Cell Lung Cancer.

Conditions

Phase 1 Portion : Non Small Cell Lung Cancer(NSCLC), Small Cell Lung Cancer(SCLC), Mesothelioma; Phase 2 Portion : Small Cell Lung Cancer(SCLC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIW-8962

Phase 1 - Dose escalation based on the BIW-8962 tolerability and safety data obtained from three subjects enrolled in a cohort (first cycle of treatment), enrollment at the next dose level or additional subjects into the ongoing cohort will occur

Phase 2 - Recommended dose determined in Phase 1

Group Type: EXPERIMENTAL

BIW-8962

Intervention Type: DRUG

Phase 1 -With a standard 3+3 dose escalation design, the enrollment in Phase 1 will proceed until the MTD has been defined or the highest dose level has been reached. BIW-8962 will be administered intravenously on day 1 of each 21 day cycle.

Phase 2 - RP2D of BIW-8962 determined in phase 1 portion will be administered until progression or unacceptable toxicity develops.

Interventions

BIW-8962

Phase 1 -With a standard 3+3 dose escalation design, the enrollment in Phase 1 will proceed until the MTD has been defined or the highest dose level has been reached. BIW-8962 will be administered intravenously on day 1 of each 21 day cycle.

Phase 2 - RP2D of BIW-8962 determined in phase 1 portion will be administered until progression or unacceptable toxicity develops.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Phase 1: histopathological-documented, measurable or non-measurable unresectable, advanced primary or recurrent SCLC, NSCLC or mesothelioma
• Phase 2: measurable, unresectable advanced or recurrent SCLC
• A life expectancy > 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 at study entry
• Echocardiogram or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) ≥ 50%, or ≥ institution's established lower limit of normal
• Adequate hematologic, hepatic, renal and lung function

Exclusion Criteria

• Subject received cytotoxic anti-cancer chemotherapy, orally available signaling pathway-targeted therapy, hormonal therapy, radiotherapy, immunotherapy, or investigational agents within 3 weeks prior to the first dose
• Subject received monoclonal antibodies within 4 weeks of the first dose
• Major surgery within 4 weeks prior to the first dose
• Known symptomatic brain metastases
• Clinically significant cardiovascular disease
• Leptomeningeal disease
• Uncontrolled intercurrent illness including ongoing or active infection, uncontrolled diabetes, etc
• Known HIV disease or acquired immunodeficiency syndrome-related illness
• A psychiatric illness, disability or social situation
• Hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins
• A history of primary brain/CNS malignancy
• Neurological paraneoplastic syndrome

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Korea Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin Korea

Seoul, , South Korea

Countries

South Korea

Other Identifiers

8962-002

Identifier Type: -

Identifier Source: org_study_id