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ACTIVE NOT RECRUITING
NCT05816252
PHASE2

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)

Sponsor: Klus Pharma Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

356

Start Date

2023-04-19

Completion Date

2026-12-30

Last Updated

2026-01-27

Healthy Volunteers

No

Interventions

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

Locations (50)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital (Chongqing Cancer Hospital)

Chongqing, Chongqing Municipality, 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

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The First Affiliated Hospital of Nanchang University

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 Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 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 Municipality, 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

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

Cluj-Napoca, Cluj, Romania

Centrul de Oncologie Sf. Nectarie

Craiova, Dolj, Romania

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggido, South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Samsung Medical Center

Seoul, Seoul Teugbyeolsi, South Korea

Inje University Haeundae Paik Hospital

Busan, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

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

Seville, Spain

Hospital Clinico Universitario De Valencia

Valencia, Spain

Medical Park Seyhan Hospital

Adana, Turkey (Türkiye)

Adana City Training and Research Hospital

Adana, Turkey (Türkiye)

Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi

Ankara, Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Gazi University Medical Faculty

Ankara, Turkey (Türkiye)