NCT07459998

SKB103 for Injection in Advanced Solid Tumors

A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB103 for Injection in Participants With Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 277 (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 SKB103 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 multi-center, open-label, phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetics (PK) characteristics, immunogenicity, and efficacy of SKB103 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	SKB103 for injection monotherapy	IV infusion on Day 1 of each cycle, every 3 weeks (Q3W), until radiographic disease progression (PD), intolerable toxicity, participant request for discontinuation, lost to follow-up, or death (whichever occurs first).

Timeline

• Start date: 2026-04-30
• Primary completion: 2029-12-31
• Completion: 2030-12-31
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

2 sites across 1 country: China