NCT06826040

SKB445 for Injection in Solid Tumors

A Phase 1 Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of SKB445 for Injection in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB445 for injection in patients with advanced solid tumors.

Detailed description

This is an open-label, dose-escalation, multicenter study to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor activity of SKB445 monotherapy in patients with advanced solid tumors.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	SKB445 for injection	SKB445 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.

Timeline

• Start date: 2025-02-05
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-02-13
• Last updated: 2025-12-05

Locations

1 site across 1 country: China