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)
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria
1. Subjects must be at least 18 years of age on day of signing informed consent, regardless of gender;
2. Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC ;
3. Subjects for NSCLC should be confirmed to be EGFR (Epidermal growth factor receptor) wild-type and ALK (Anaplastic lymphoma kinase) fusion gene negative; or confirmed to harbor EGFR mutation;
4. Locally advanced or metastatic NSCLC subjects without actionable EGFR mutations and ALK fusion genes, no prior systemic treatment; subjects with EGFR mutation, no prior systemic treatment or failed prior EGFR-TKI (Tyrosine kinase inhibitor) treatment;
5. Subjects are able to provide tumor blocks or slides before the first dose of study intervention;
6. Subject must have at least one radiographically measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria;
7. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1;
8. Life expectancy at least 3 months for the subject;
9. Adequate organ function;
10. Subjects must have recovered from all toxicities led by prior treatment;
11. Contraceptive methods used by male and female subjects must comply with contraceptive methods of local regulations for clinical study subjects;
12. Subjects should voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures.
Exclusion Criteria
1. Subjects with mixed SCLC histopathological features;
2. Subjects with a known history of prior malignancy;
3. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active central nervous system (CNS) metastases;
4. Subjects with ≥ Grade 2 peripheral neuropathy;
5. Subjects who had arteriovenous thromboembolic events, tumor invasion/encasement of vital organs/vessels, risk of esophageal-tracheal/pleural fistula, or current superior vena cava syndrome;
6. Subjects with active inflammatory bowel disease or previous clear history of inflammatory bowel disease;
7. Subjects who suffer from cardiovascular diseases of clinical significance;
8. Subjects with a history of interstitial lung disease (ILD)/non-infectious pneumonitis that required steroids;
9. Subjects with uncontrolled systemic disease as judged by the Investigator;
10. Subjects with active autoimmune disease that required systemic treatment in the past 2 years;
11. Subjects with active hepatitis B or hepatitis C;
12. Subjects with known history of Human Immunodeficiency Virus (HIV)
13. Subjects with known active tuberculosis;
14. Subjects with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
15. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study;
16. Subjects whose condition deteriorated rapidly, such as severe changes in performance status, during the screening process prior to the first dose of study intervention;
17. Subjects with other circumstances that, in the opinion of the Investigator, are not appropriate for participation in this study.
Primary outcome measure(s)
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
Trial sites (50)
Facility
City
Region
Status
Beijing Cancer Hospital
Beijing
Beijing Municipality
Chongqing University Cancer Hospital (Chongqing Cancer Hospital)
Chongqing
Chongqing Municipality
Fujian Cancer Hospital
Fuzhou
Fujian
Sun Yat-Sen University Cancer Center
Guangzhou
Guangdong
Sun Yatsen University Cancer Center Huangpu Hos
Guangzhou
Guangdong
Guangxi Cancer Hospital/ Guangxi Medical University Cancer Hospital
Nanning
Guangxi
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
The First Affiliated Hospital of Zhengzhou University(Heyi Compus)
Zhengzhou
Henan
Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou
Henan
Zhongnan Hospital of Wuhan University
Wuhan
Hubei
Hubei Cancer Hospital
Wuhan
Hubei
Hunan Cancer Hospital
Changsha
Hunan
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Jilin Cancer Hospital
Changchun
Jilin
The First Hospital of Jilin University
Changchun
Jilin
The First Hospital of Chinese Medical University(Heping Compus)
Shenyang
Liaoning
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Shaanxi
Shandong Cancer Hospital and Institute
Jinan
Shandong
Shanghai Chest Hospital
Shanghai
Shanghai Municipality
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
Shanxi Provincial Cancer Hospital
Taiyuan
Shanxi
Sichuan Cancer Hospital
Chengdu
Sichuan
West China Hospital of Sichuan University
Chengdu
Sichuan
Chengdu Fifth People's Hospital
Chengdu
Sichuan
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Tianjin Municipality
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Zhejiang
Zhejiang Cancer Hospital
Hangzhou
Zhejiang
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
Centrul de Oncologie Sf. Nectarie
Craiova
Dolj
The Catholic University of Korea, St. Vincent's Hospital
Suwon
Gyeonggido
Chungbuk National University Hospital
Cheongju-si
North Chungcheong
Samsung Medical Center
Seoul
Seoul Teugbyeolsi
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
Hospital Universitario QuirónSalud Madrid
Pozuelo de Alarcón
Madrid
Micancer Center S.L.P.
Barcelona
Spain
+ 10 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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