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

Kyowa Kirin

Status and phase: Terminated; Phase 2; Phase 1

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

Treatments: Drug: BIW-8962

Study type: Interventional

Funder types: Industry

Identifiers

NCT01898156

8962-002

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

BIW-8962

Experimental group

Description:

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

Treatment:

Drug: BIW-8962