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)
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 498
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 7-1 1L NSCLC with EGFR mutation SKB264 SKB264 (Dose Level 2) + Osimertinib Cohort 7-1 1L NSCLC with EGFR mutation Osimertinib SKB264 (Dose Level 2) + Osimertinib Cohort 9 2/3L NSCLC EGFR/ALK negative SKB264 SKB264 (Dose Level 1) Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1% SKB264 SKB264 (Dose Level 1) + Pembrolizumab Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1% Pembrolizumab 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 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 4 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 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 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapy Carboplatin SKB264 (Dose Level 1'') + Carboplatin 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 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
The First Affiliated Hospital of Zhengzhou University(Heyi Compus)
🇨🇳Zhengzhou, Henan, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Sun Yatsen University Cancer Center Huangpu Hos
🇨🇳Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Guangxi Cancer Hospital/ Guangxi Medical University Cancer Hospital
🇨🇳Nanning, Guangxi, China
Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The First Hospital of Chinese Medical University(Heping Compus)
🇨🇳Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
Shandong Cancer Hospital and Institute
🇨🇳Jinan, Shandong, China
Shanghai Chest Hospital
🇨🇳Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
Sichuan Cancer Hospital
🇨🇳Chengdu, Sichuan, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Chengdu Fifth People's Hospital
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China
Yunnan Cancer Hospital,The Third Affiliated Hospital of Kunming Medical University ,Yunnan Cancer Center
🇨🇳Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
ISR-GEO Med Res Clin Healthycore
🇬🇪Tbilisi, Georgia
LLC "Todua Clinic"
🇬🇪Tbilisi, Georgia
Ltd New Hospitals
🇬🇪Tbilisi, Georgia
Tbilisi St Med U Ingorokva High Med
🇬🇪Tbilisi, Georgia
LTD Institute of Clinical Oncology
🇬🇪Tbilisi, Georgia
Chungbuk National University Hospital
🇰🇷Cheongju-si, Chungcheongbugdo, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-Si, Gyeonggido, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon-Si, Gyeonggido, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
🇷🇴Cluj-Napoca, Cluj, Romania
Medisprof
🇷🇴Cluj-Napoca, Cluj, Romania
Centrul de Oncologie Sf. Nectarie
🇷🇴Craiova, Dolj, Romania
Hospital Universitario Puerta De Hierro De Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitario QuirónSalud Madrid
🇪🇸Pozuelo de Alarcón, Madrid, Spain
Micancer Center S.L.P.
🇪🇸Barcelona, Spain
Hospital Universitari Dexeus Grupo Quironsalud
🇪🇸Barcelona, Spain
Hospital Universitari Vall D Hebron
🇪🇸Barcelona, Spain
Hospital Quironsalud Malaga
🇪🇸Málaga, Spain
Hospital Universitario Virgen de Valme
🇪🇸Sevilla, Spain
Hospital Clinico Universitario De Valencia
🇪🇸Valencia, Spain
Medical Park Seyhan Hospital
🇹🇷Adana, Turkey
Adana City Training and Research Hospital
🇹🇷Adana, Turkey
Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi
🇹🇷Ankara, Turkey
Hacettepe University Medical Faculty
🇹🇷Ankara, Turkey
Gazi University Medical Faculty
🇹🇷Ankara, Turkey
Ankara Liv Hospital Tibbi Onkoloji
🇹🇷Ankara, Turkey
Inonu University Turgut Ozal Medical Center
🇹🇷Malatya, Turkey