NCT06944444

A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors

A Phase I Clinical Study of the Safety, Pharmacokinetics, and Antitumor Activity of SSS59 in Patients With Advanced Malignant Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSS59 as a single agent in patients with advanced malignancies.

Detailed description

This study includes 4 Parts: Part A1 (dose escalation and dose extension for QW administration), Part A2 (dose escalation and dose extension for Q2W administration), Part A3 (dose extension for Q3W administration), and Part B (indication extension, such as advanced gastric or gastroesophageal junction adenocarcinoma with MUC17 positive, failure of standard therapy, or intolerance to standard therapy , or other tumors).

Conditions

• Malignant Tumors

Interventions

Type	Name	Description
DRUG	SSS59	A humanized antibody targeting MUC17

Timeline

• Start date: 2025-04-27
• Primary completion: 2027-03-01
• Completion: 2027-12-31
• First posted: 2025-04-25
• Last updated: 2025-04-29

Locations

1 site across 1 country: China