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

NCT01898156 | Terminated Phase 1

• 1 other identifier: 8962-002
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Phase 1 - To evaluate preliminary efficacy

  Until Progressive Disease (PD) determined

• 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 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

Study Arms (1)

BIW-8962

EXPERIMENTAL

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

Drug: BIW-8962

Interventions

BIW-8962 DRUG

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.

BIW-8962

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Korea Co., Ltd.: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin Korea

Seoul, South Korea

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Mesothelioma

Interventions

BIW-8962

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: July 12, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

KR (1)