Clinical Research Directory
Browse clinical research sites, groups, and studies.
SKB500 Combinations in Patients With Small Cell Lung Cancer
Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Summary
The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase.
Official title: A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of SKB500 Combinations in Patients With Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-01-30
Completion Date
2029-12-31
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
SKB500 Powder for Injection
SKB500 will be administered as an intravenous (IV) infusion, every 3 weeks on Day 1 of each 21-day cycle and the dose will be determined based on the efficacy and safety data from the SKB500-I-01 study.
KL-A167 Injection
KL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg)
Carboplatin Injection
Carboplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle(AUC 5, Cycles 1-4)
Etoposide Injection
Etoposide will be administered as an intravenous (IV) infusion every 3 weeks on Day 1, 2, and 3 of each 21-day cycle (100 mg/m\^2, Cycles 1-4).
Locations (1)
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China