NCT07380386

SKB105 for Injection in Advanced Solid Tumors

A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB105 for Injection in Participants With Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2 clinical study to evaluate the safety and efficacy of SKB105 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.

Detailed description

This is a multicenter, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability, Pharmacokinetics(PK) characteristics, immunogenicity, and efficacy of SKB105 in participants with advanced solid tumors. The study includes a Phase 1 dose escalation stage, a Phase 1 dose expansion stage, and a Phase 2 indication expansion stage.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	SKB105 for injection Monotherapy	SKB105 for injection monotherapy, iv drip, every 3 weeks (Q3W), until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-12-31
• Completion: 2030-12-31
• First posted: 2026-02-02
• Last updated: 2026-02-02

Locations

2 sites across 1 country: China