A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816252
• Other study ID #: SKB264-II-04
• Status: Recruiting
• Phase: Phase 2
• Start date: April 19, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: June 2024
• Source: Klus Pharma Inc.
• Contact: Xiaoping Jin, PhD
• Phone: 86-028-67255165
• Email: jinxp[@]kelun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a multicenter, open-label study of SKB264 as combination therapy in subjects with NSCLC. Approximately up to 296 subjects will be enrolled in this study including around 36 (may expand) subjects for safety run-in period and 200 subjects for expansion period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 278
• Est. completion date: August 31, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• SKB264
intravenous (IV) infusion (Q2W or Q3W)
• Pembrolizumab
intravenous (IV) infusion (400mg, Q6W)
• Carboplatin
intravenous (IV) infusion (AUC5, Q3W)
• Osimertinib
80mg, QD

Locations

Country	Name	City	State
Australia	St Vincent's Hospital - Kinghorn Cancer Centre	Darlinghurst	New South Wales
Australia	Paula Fox Melanoma and Cancer Centre	Melbourne	Victoria
Australia	South West Oncology	Warrnambool	Victoria
China	Beijing Cancer Hospital	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Hunan Cancer hospital	Changsha	Hunan
China	Sichuan Cancer Hospital	Chengdu	Sichuan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
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	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Shandong Cancer Hospital and Institute	Jinan	Shandong
China	Yunnan Cancer Hospital,The Third Affiliated Hospital of Kunming Medical University ,Yunnan Cancer Center	Kunming	Yunnan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Shanghai East Hospital	Shanghai	Shanghai
China	The First Hospital of Chinese Medical University(Heping Compus)	Shenyang	Liaoning
China	Shanxi Provincial Cancer Hospital	Taiyuan	Shanxi
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou University	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University(Heyi Compus)	Zhengzhou	Henan
Georgia	High Technology Hospital MedCenter LTD	Batumi	Ajaria
Georgia	ISR-GEO Med Res Clin Healthycore	Tbilisi
Georgia	LLC "Todua Clinic"	Tbilisi
Georgia	LTD "Multiprofile Clinic Consilium Medulla"	Tbilisi
Georgia	LTD Institute of Clinical Oncology	Tbilisi
Georgia	Ltd New Hospitals	Tbilisi
Georgia	Tbilisi St Med U Ingorokva High Med	Tbilisi
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan	Busan Gwang'yeogsi [Pusan-Kwangyokshi]
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si	Chungcheongbugdo [Ch'ungch'ongbuk-do]
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-Si	Gyeonggido [Kyonggi-do]
Korea, Republic of	Samsung Medical Center	Seoul	Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
Korea, Republic of	The Catholic University of Korea, St. Vincent's Hospital	Suwon-Si	Gyeonggido [Kyonggi-do]
Romania	Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca	Cluj-Napoca	Cluj
Romania	Medisprof	Cluj-Napoca	Cluj
Romania	Ovidius Clinical Hospital	Constanta	Ovidiu
Romania	Centrul de Oncologie Sf. Nectarie	Craiova	Dolj
Spain	Hospital Universitari Dexeus Grupo Quironsalud	Barcelona
Spain	Hospital Universitari Vall D Hebron	Barcelona
Spain	Micancer Center S.L.P.	Barcelona
Spain	Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Madrid
Spain	Hospital Quironsalud Malaga	Málaga
Spain	Hospital Universitario QuirónSalud Madrid	Pozuelo de Alarcón	Madrid
Spain	Hospital Universitario Virgen de Valme	Sevilla
Spain	Hospital Clinico Universitario De Valencia	Valencia
Turkey	Adana City Training and Research Hospital	Adana
Turkey	Medical Park Seyhan Hospital	Adana
Turkey	Ankara Liv Hospital Tibbi Onkoloji	Ankara
Turkey	Gazi University Medical Faculty	Ankara
Turkey	Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi	Ankara
Turkey	Hacettepe University Medical Faculty	Ankara
Turkey	Medical Point Izmir Hospital	Izmir
Turkey	Inonu University Turgut Ozal Medical Center	Malatya

Sponsors (2)

Lead Sponsor	Collaborator
Klus Pharma Inc.	Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Countries where clinical trial is conducted

Australia,  China,  Georgia,  Korea, Republic of,  Romania,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	Dose-limiting toxicity (DLT); Incidence and severity of adverse events (AEs); Discontinuation of study treatment due to AEs	From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment, up to approximately 36 months
Primary	ORR	Objective response rate (ORR) per RECIST v1.1	The proportion of subjects with a confirmed complete response (CR) or partial response (PR), up to approximately 36 months
Secondary	Duration of response (DOR)	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	From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months
Secondary	Progression-free survival (PFS)	The time from first dose of study intervention to first documentation of radiographic disease progression or death due to any cause, whichever occurs first	From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months
Secondary	Overall survival (OS)	the time period from the start of study intervention to death due to any cause.	From baseline until death due to any cause, up to approximately 36 months