NCT06428331

A Study of SKB518 in Patients With Advanced Solid Tumors

A Phase 1, Multicenter, Open-label First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of SKB518 in Subjects With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard therapy is available.

Detailed description

This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard therapy is available. Dose escalation and de-escalation decisions are based on the mTPI-2 design and depend on the number of subjects enrolled and the number of DLTs observed at the current dose level.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	SKB518 for injection	SKB518 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: 2024-07-04
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-05-24
• Last updated: 2025-12-05

Locations

1 site across 1 country: China