NCT07076095

A Phase II/III Study of IBB0979 in Combination With Topotecan Versus Topotecan in Relapsed Small Cell Lung Cancer

A Phase II/III Study to Compare IBB0979 in Combination With Topotecan Versus Topotecan in Subjects With Relapsed Small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to compare the efficacy and safety of IBB0979 in combination with topotecan versus topotecan in subjects with relapsed small cell lung cancer (SCLC).

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	IBB0979	bifunctional antibody-cytokine fusion protein that targets B7-H3 and IL-10 receptor
DRUG	topotecan hydrochloride for injection	Topotecan hydrochloride will be administered intravenously per prescribing information.

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-08-01
• Completion: 2031-08-01
• First posted: 2025-07-21
• Last updated: 2025-07-21

Regulatory

• FDA-regulated drug study