NCT06736327

A Study on the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SKB500 in Subjects With Advanced Solid Tumors

A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SKB500 for Injection in Subjects With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety, tolerability, PK profile, immunogenicity, and antitumor activity of SKB500 in subjects with advanced solid tumors.

Detailed description

This study is a multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, PK profile, immunogenicity, and antitumor activity of SKB500 in subjects with advanced solid tumors. The study includes a dose-escalation phase, a dose-expansion phase, and an indication-expansion phase.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	SKB500	The administration route of SKB500 is intravenous infusion, with a dosing frequency of Q3W.

Timeline

• Start date: 2024-12-13
• Primary completion: 2027-07-31
• Completion: 2028-12-31
• First posted: 2024-12-16
• Last updated: 2025-12-08

Locations

1 site across 1 country: China