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A Phase I Clinical Study of HS-20117 in Participants With Advanced Solid Tumors

Non-Small Cell Lung Cancer Clinical Trial

Official title:
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20117 in Participants With Advanced Solid Tumors

Clinical Trial Summary

HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of HS-20117 as a monotherapy for participants with advanced solid tumors.

Clinical Trial Description

This is a multicenter, open-label, Phase I clinical study of HS-20117 to evaluate the safety, tolerability, PK, immunogenicity and efficacy in participants with advanced solid tumors. The study consists of phase Ia (dose escalation) and phase Ib (dose expansion). The dose-escalation study will be performed to evaluate the safety, tolerability, PK profile, immunogenicity, and efficacy of HS-20117 in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. The subsequent dose-expansion study will be performed to evaluate the efficacy of HS-20117 in participants with locally advanced or metastatic NSCLC who have progressed after prior platinum-based chemotherapy or are intolerant to platinum-based chemotherapy with EGFR exon 20 insertion mutations, and to explore the efficacy of HS-20117 in participants with other advanced solid tumors. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05940116
Study type Interventional
Source Hansoh BioMedical R&D Company
Contact Peng Zhou
Phone +86 18013002767
Email zhoup7@hspharm.com
Status Not yet recruiting
Phase Phase 1
Start date July 20, 2023
Completion date July 30, 2027
View Details
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