NCT07462923

HS-20093 in Patients With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

A Phase Ib Clinical Study on the Efficacy, Safety, Tolerability, and Pharmacokinetics of HS-20093 in Patients With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hansoh BioMedical R&D Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

HS-20093 is a humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. This is a phase 1b, open-label, multi-center study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of HS-20093 in patients with advanced gastric and gastroesophageal junction adenocarcinoma.

Detailed description

The first approximately 20 eligible participants who meet the inclusion criteria and do not meet the exclusion criteria will receive intravenous infusion of 8.0 mg/kg HS-20093 once every three weeks (Q3W). Treatment will continue until objective disease progression or other treatment discontinuation criteria are met. Based on preliminary safety, efficacy, and pharmacokinetic data, the sponsor may decide whether subsequent participants will continue the current dosing regimen (8.0 mg/kg, Q3W), switch to a lower dose (e.g., 6.0 mg/kg, Q3W), a higher dose (e.g., 10.0 mg/kg, Q3W), or transition to a dosing frequency of once every two weeks (with a single dose not exceeding 6.0 mg/kg).

Conditions

• Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	HS-20093 for injection	Intravenous (IV) infusion of HS-20093 Q3W; Participants will receive continuous treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Timeline

• Start date: 2026-01-29
• Primary completion: 2026-12-31
• Completion: 2028-03-31
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study