Phase 1 Portion : Non Small Cell Lung Cancer(NSCLC), Small Cell Lung Cancer(SCLC), Mesothelioma, Phase 2 Portion : Small Cell Lung Cancer(SCLC)
Conditions
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.
Interventions
DRUGBIW-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.
Sponsors
Kyowa Kirin Korea Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed