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)

Phase 2

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: SKB264; Drug: Pembrolizumab; Drug: Osimertinib; Drug: Carboplatin

• Registration Number: NCT05816252
• Lead Sponsor: Klus Pharma Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-18
• Study Start: 2023-04-19
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-29
• Primary Completion: 2025-12-01
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1%	SKB264	SKB264 (Dose Level 1) + Pembrolizumab
Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level	SKB264	SKB264 (Dose Level 1') + Pembrolizumab + Carboplatin
Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level	Pembrolizumab	SKB264 (Dose Level 1') + Pembrolizumab + Carboplatin
Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level	Carboplatin	SKB264 (Dose Level 1') + Pembrolizumab + Carboplatin
Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapy	SKB264	SKB264 (Dose Level 1') + Carboplatin
Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1%	Pembrolizumab	SKB264 (Dose Level 1) + Pembrolizumab
Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level	SKB264	SKB264 (Dose Level 1'') + Pembrolizumab + Carboplatin
Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level	Pembrolizumab	SKB264 (Dose Level 1'') + Pembrolizumab + Carboplatin
Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapy	Carboplatin	SKB264 (Dose Level 1') + Carboplatin
Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapy	SKB264	SKB264 (Dose Level 1'') + Carboplatin
Cohort 9 2/3L NSCLC EGFR/ALK negative	SKB264	SKB264 (Dose Level 1)
Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level	Carboplatin	SKB264 (Dose Level 1'') + Pembrolizumab + Carboplatin
Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapy	Carboplatin	SKB264 (Dose Level 1'') + Carboplatin
Cohort 7-1 1L NSCLC with EGFR mutation	SKB264	SKB264 (Dose Level 2) + Osimertinib
Cohort 7 1L NSCLC with EGFR mutation	SKB264	SKB264 (Dose Level 1) + Osimertinib
Cohort 7 1L NSCLC with EGFR mutation	Osimertinib	SKB264 (Dose Level 1) + Osimertinib
Cohort 7-1 1L NSCLC with EGFR mutation	Osimertinib	SKB264 (Dose Level 2) + Osimertinib

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment, up to approximately 36 months	Dose-limiting toxicity (DLT); Incidence and severity of adverse events (AEs); Discontinuation of study treatment due to AEs
ORR	The proportion of subjects with a confirmed complete response (CR) or partial response (PR), up to approximately 36 months	Objective response rate (ORR) per RECIST v1.1

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR)	From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months	For subjects with a confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until radiographic disease progression or death due to any cause, whichever occurs first
Progression-free survival (PFS)	From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months	The time from first dose of study intervention to first documentation of radiographic disease progression or death due to any cause, whichever occurs first
Overall survival (OS)	From baseline until death due to any cause, up to approximately 36 months	the time period from the start of study intervention to death due to any cause.

Trial Locations

Locations (60)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Chongqing University Cancer Hospital (Chongqing Cancer Hospital); 🇨🇳 Chongqing, Chongqing, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Sun Yatsen University Cancer Center Huangpu Hos; 🇨🇳 Guangzhou, Guangdong, China

Guangxi Cancer Hospital/ Guangxi Medical University Cancer Hospital; 🇨🇳 Nanning, Guangxi, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University(Heyi Compus); 🇨🇳 Zhengzhou, Henan, China

Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

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