NCT06621563

Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors

Safety, Tolerability, Efficacy, Pharmacokinetics Profile and Immunogenicity of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors, a Phase Ib Clinical Trial

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 780 (estimated)
• Sponsor: Hansoh BioMedical R&D Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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, efficacy, PK profile and immunogenicity of HS-20117 in combination with other drugs in advanced solid tumors.

Detailed description

This is a multicenter, open-label, Phase Ib clinical trial of HS-20117 combination therapies to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity in participants with advanced solid tumors. The study includes a dose escalation part and a dose expansion part. The dose-escalation study will be performed to evaluate the safety, tolerability, PK profile, immunogenicity, and efficacy of HS-20117 combination therapies in participants with advanced solid tumor. The subsequent dose-expansion study will be performed to evaluate the efficacy of HS-20117 combination therapies in participants with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations or EGFR classical mutations, and RAS/BRAF V600E wild type CRC.

Conditions

• Solid Tumors
• Non-Small Cell Lung Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	HS-20117 combined HS-20093	HS-20117 + HS-20093
DRUG	HS-20117 combined Platinum-containing chemotherapy	HS-20117 + cisplatin/carboplatin + pemetrexed
DRUG	HS-20117 combined HS-20093 and 5-FU	HS-20117 + HS-20093 + 5-FU
DRUG	HS-20117+CAPEOX	CAPOEX: Oxaliplatin+Capecitabine
DRUG	HS-20117+FOLFIRI	FOLFIRI=Irinotecan+Leucovorin Calcium+5-FU
DRUG	HS-20117+mFOLFOX6	mFOLFOX6=Oxaliplatin+Leucovorin Calcium+5-FU

Timeline

• Start date: 2024-12-14
• Primary completion: 2026-03-30
• Completion: 2026-12-01
• First posted: 2024-10-01
• Last updated: 2025-04-09

Locations

1 site across 1 country: China