Clinical trial NCT01898156: Two-Part, Open-Label, Multi-Center, Phase 1/2 Study of BIW-8962 as Monotherapy in Subjects With Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Phase 1 Portion : Non Small Cell Lung Cancer(NSCLC), Small Cell Lung Cancer(SCLC), Mesothelioma
Phase 2 Portion : Small Cell Lung Cancer(SCLC)
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Phase 1 - To determine Maximum Tolerated Dose(MTD)
timeFrame: First 3-week cycle of treatment
measure: Phase 2 - To assess the objective response rate(Partial Response and Complete Response)
timeFrame: Until Progressive Disease (PD) determined
Secondary outcomes:
measure: Phase 1 - To evaluate preliminary efficacy
timeFrame: Until Progressive Disease (PD) determined
measure: Phase 1 - To determine the q3w pharmacokinetic profile of BIW-8962
timeFrame: 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
measure: Phase 2 - To assess safety and tolerance
timeFrame: Every 3 weeks, until 45days after the last dose or within 7 days prior to the initiation of subsequent anti-cancer treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin Korea
Study officials:
References: