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RECRUITING
NCT07296809
PHASE2

SKB500 Combinations in Patients With Small Cell Lung Cancer

Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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)

DRUG

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)

DRUG

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