TrialSignal
Clinical trial intelligence report
A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability and Pharmacokinetics of ISU104, a Human Monoclonal Antibody Targeting ErbB3 in Patients With Advanced Solid Tumors
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jul 28, 2026
Report code
NCT03552406-Jul 28, 2026
NCT ID
NCT03552406
Status
UNKNOWN
Phase
Phase 1
Sponsor
ISU Abxis Co., Ltd.
Executive brief
Investment-Ready Snapshot
ISU104, a human monoclonal antibody targeting ErbB3, is currently in a Phase I clinical trial aimed at assessing its safety, tolerability, and pharmacokinetics in patients with advanced solid tumors. The trial's dual-part design includes a dose-escalation phase to establish the recommended Phase II dose (RP2D) and a dose-expansion phase focusing on recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Given the increasing interest in targeted therapies for solid tumors, ISU104 could position ISU Abxis Co., Ltd. favorably within a competitive landscape that includes established therapies like cetuximab. The trial's outcomes may provide critical insights into the drug's efficacy and safety profile, influencing future development strategies and potential partnerships.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT03552406
Indication
Solid Tumor
Modality
protein therapy
Target
ErbB3 (HER3), a member of the epidermal growth factor receptor (EGFR) family, involved in tumor growth and survival signaling pathways.
Intervention
ISU104, Cetuximab
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.