Clinical trial 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)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Klus Pharma Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
First posted: 2023-04-18
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: Safety and tolerability
timeFrame: From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment, up to approximately 36 months
measure: ORR
timeFrame: The proportion of subjects with a confirmed complete response (CR) or partial response (PR), up to approximately 36 months
Secondary outcomes:
measure: Duration of response (DOR)
timeFrame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months
measure: Progression-free survival (PFS)
timeFrame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months
measure: Overall survival (OS)
timeFrame: From baseline until death due to any cause, up to approximately 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital (Chongqing Cancer Hospital)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yatsen University Cancer Center Huangpu Hos
state: Guangdong
city: Nanning
country: China
facility: Guangxi Cancer Hospital/ Guangxi Medical University Cancer Hospital
state: Guangxi
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University(Heyi Compus)
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of Chinese Medical University(Heping Compus)
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Fifth People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Kunming
country: China
facility: Yunnan Cancer Hospital,The Third Affiliated Hospital of Kunming Medical University ,Yunnan Cancer Center
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Tbilisi
country: Georgia
facility: ISR-GEO Med Res Clin Healthycore
city: Tbilisi
country: Georgia
facility: LLC "Todua Clinic"
city: Tbilisi
country: Georgia
facility: Ltd New Hospitals
city: Tbilisi
country: Georgia
facility: Tbilisi St Med U Ingorokva High Med
city: Tbilisi
country: Georgia
facility: LTD Institute of Clinical Oncology
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbugdo
city: Seongnam-Si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggido
city: Suwon-Si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul Teugbyeolsi
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Medisprof
state: Cluj
city: Craiova
country: Romania
facility: Centrul de Oncologie Sf. Nectarie
state: Dolj
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta De Hierro De Majadahonda
state: Madrid
city: Pozuelo de Alarcón
country: Spain
facility: Hospital Universitario QuirónSalud Madrid
state: Madrid
city: Barcelona
country: Spain
facility: Micancer Center S.L.P.
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus Grupo Quironsalud
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D Hebron
city: Málaga
country: Spain
facility: Hospital Quironsalud Malaga
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Valencia
country: Spain
facility: Hospital Clinico Universitario De Valencia
city: Adana
country: Turkey
facility: Medical Park Seyhan Hospital
city: Adana
country: Turkey
facility: Adana City Training and Research Hospital
city: Ankara
country: Turkey
facility: Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara Liv Hospital Tibbi Onkoloji
city: Malatya
country: Turkey
facility: Inonu University Turgut Ozal Medical Center
Study officials:
References: