NCT05816252

A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)

A Phase II Study of SKB264 as Monotherapy or as Combination Therapy in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: Klus Pharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer.

Detailed description

This is a multicenter, open-label study of SKB264 as combination therapy or monotherapy in subjects with NSCLC. Approximately 498 subjects will be enrolled in this study including around 88 subjects for the safety run-in period and 410 subjects for the expansion period.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SKB264	intravenous (IV) infusion (Q2W or Q3W)
DRUG	Pembrolizumab	intravenous (IV) infusion (400mg, Q6W)
DRUG	Carboplatin	intravenous (IV) infusion (AUC5, Q3W)
DRUG	Osimertinib	80mg, QD

Timeline

• Start date: 2023-04-19
• Primary completion: 2026-06-30
• Completion: 2026-12-30
• First posted: 2023-04-18
• Last updated: 2026-01-27

Locations

50 sites across 6 countries: China, Georgia, Romania, South Korea, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study