Two-Part, Open-Label, Multi-Center, Phase 1/2 Study of BIW-8962 as Monotherapy in Subjects With Lung Cancer
- Conditions
- Phase 1 Portion : Non Small Cell Lung Cancer(NSCLC), Small Cell Lung Cancer(SCLC), MesotheliomaPhase 2 Portion : Small Cell Lung Cancer(SCLC)
- Interventions
- Registration Number
- NCT01898156
- Lead Sponsor
- Kyowa Kirin Korea Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 37
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BIW-8962 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
- Primary Outcome Measures
Name Time Method Phase 2 - To assess the objective response rate(Partial Response and Complete Response) Until Progressive Disease (PD) determined Phase 2 - Tumor response and progression will be evaluated every 6 weeks using RECIST v 1.1. Partial Response (PR) or Complete Response (CR) will be confirmed 4 weeks after first detection of response.
Phase 1 - To determine Maximum Tolerated Dose(MTD) First 3-week cycle of treatment Phase 1 -Adverse Event collection and assessment will be done for all potentially treated subjects to assess the safety, tolerability, and determine the DLTs, maximum tolerated dose (MTD).
- Secondary Outcome Measures
Name Time Method Phase 1 - To evaluate preliminary efficacy Until Progressive Disease (PD) determined Phase 1 - Tumor response progression will be evaluated using RECIST V1.1 for the assessment of efficacy
Phase 1 - To determine the q3w pharmacokinetic profile of BIW-8962 Pre-dose, and Day 1, 2, 3, 5, 8, 12 and 15 in Cycle 1 and 3, Pre-dose in Cycle 2, 4, 5,and up to Cycle 6 Phase 1 - Pharmacokinetic (PK) parameters such as Maximum concentration (Cmax), time to maximum concentration (Tmax), minimum concentration(Cmin), area under the curve (AUC), half-life (t1/2), clearance (CL), and etc., are assessed.
Phase 2 - To assess safety and tolerance Every 3 weeks, until 45days after the last dose or within 7 days prior to the initiation of subsequent anti-cancer treatment Phase 2 - All safety information will be collected and then evaluated.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin Korea
🇰🇷Seoul, Korea, Republic of