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

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.

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).