Clinical trial · Interventional
Two-Part, Open-Label, Multi-Center, Phase 1/2 Study of BIW-8962 as Monotherapy in Subjects With Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of efficacy
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Phase 1 Portion : Non Small Cell Lung Cancer(NSCLC), Small Cell Lung Cancer(SCLC), Mesothelioma | Malignant Mesothelioma | PROBABILISTIC | 0.70 |
| Phase 2 Portion : Small Cell Lung Cancer(SCLC) | Lung Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIW-8962 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BIW-8962
- description
- 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
- interventionNames
- Drug: BIW-8962
Primary outcomes (2)
- measure
- Phase 1 - To determine Maximum Tolerated Dose(MTD)
- timeFrame
- First 3-week cycle of treatment
- description
- 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).
- measure
- Phase 2 - To assess the objective response rate(Partial Response and Complete Response)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available