Phase 1 Portion : Non Small Cell Lung Cancer(NSCLC), Small Cell Lung Cancer(SCLC), Mesothelioma Clinical Trial
Official title:
Two-Part, Open-Label, Multi-Center, Phase 1/2 Study of Anti-GM2 Ganglioside Monoclonal Antibody BIW-8962 as Monotherapy in Subjects With Previously Treated Advanced/Recurrent Lung Cancer or Mesothelioma
| Verified date | April 2024 |
| Source | Kyowa Kirin Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 37 |
| Est. completion date | June 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin Korea | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Kyowa Kirin Korea Co., Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Phase 1 - To determine Maximum Tolerated Dose(MTD) | 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). | First 3-week cycle of treatment | |
| Primary | Phase 2 - To assess the objective response rate(Partial Response and Complete Response) | 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. | Until Progressive Disease (PD) determined | |
| Secondary | Phase 1 - To evaluate preliminary efficacy | Phase 1 - Tumor response progression will be evaluated using RECIST V1.1 for the assessment of efficacy | Until Progressive Disease (PD) determined | |
| Secondary | Phase 1 - To determine the q3w pharmacokinetic profile of BIW-8962 | 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. | 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 | |
| Secondary | Phase 2 - To assess safety and tolerance | Phase 2 - All safety information will be collected and then evaluated. | Every 3 weeks, until 45days after the last dose or within 7 days prior to the initiation of subsequent anti-cancer treatment |