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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05816252




Registration number
NCT05816252
Ethics application status
Date submitted
3/04/2023
Date registered
18/04/2023
Date last updated
19/09/2024

Titles & IDs
Public title
A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Scientific title
A Phase II Study of SKB264 as Monotherapy or as Combination Therapy in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer
Secondary ID [1] 0 0
SKB264-II-04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SKB264
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Osimertinib

Experimental: Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS = 1% - SKB264 (Dose Level 1) + Pembrolizumab

Experimental: Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level - SKB264 (Dose Level 1') + Pembrolizumab + Carboplatin

Experimental: Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level - SKB264 (Dose Level 1'') + Pembrolizumab + Carboplatin

Experimental: Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapy - SKB264 (Dose Level 1') + Carboplatin

Experimental: Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapy - SKB264 (Dose Level 1'') + Carboplatin

Experimental: Cohort 7 1L NSCLC with EGFR mutation - SKB264 (Dose Level 1) + Osimertinib

Experimental: Cohort 7-1 1L NSCLC with EGFR mutation - SKB264 (Dose Level 2) + Osimertinib


Treatment: Drugs: SKB264
intravenous (IV) infusion (Q2W or Q3W)

Treatment: Drugs: Pembrolizumab
intravenous (IV) infusion (400mg, Q6W)

Treatment: Drugs: Carboplatin
intravenous (IV) infusion (AUC5, Q3W)

Treatment: Drugs: Osimertinib
80mg, QD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability
Timepoint [1] 0 0
From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment, up to approximately 36 months
Primary outcome [2] 0 0
ORR
Timepoint [2] 0 0
The proportion of subjects with a confirmed complete response (CR) or partial response (PR), up to approximately 36 months
Secondary outcome [1] 0 0
Duration of response (DOR)
Timepoint [1] 0 0
From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months
Secondary outcome [2] 0 0
Progression-free survival (PFS)
Timepoint [2] 0 0
From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months
Secondary outcome [3] 0 0
Overall survival (OS)
Timepoint [3] 0 0
From baseline until death due to any cause, up to approximately 36 months

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2026
Actual
Sample size
Target
498
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Kinghorn Cancer Centre - Darlinghurst
Recruitment hospital [2] 0 0
Paula Fox Melanoma and Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
South West Oncology - Warrnambool
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3280 - Warrnambool
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Chongqing
Country [3] 0 0
China
State/province [3] 0 0
Fujian
Country [4] 0 0
China
State/province [4] 0 0
Guangdong
Country [5] 0 0
China
State/province [5] 0 0
Guangxi
Country [6] 0 0
China
State/province [6] 0 0
Heilongjiang
Country [7] 0 0
China
State/province [7] 0 0
Henan
Country [8] 0 0
China
State/province [8] 0 0
Hubei
Country [9] 0 0
China
State/province [9] 0 0
Hunan
Country [10] 0 0
China
State/province [10] 0 0
Jiangxi
Country [11] 0 0
China
State/province [11] 0 0
Jilin
Country [12] 0 0
China
State/province [12] 0 0
Liaoning
Country [13] 0 0
China
State/province [13] 0 0
Shaanxi
Country [14] 0 0
China
State/province [14] 0 0
Shandong
Country [15] 0 0
China
State/province [15] 0 0
Shanghai
Country [16] 0 0
China
State/province [16] 0 0
Shanxi
Country [17] 0 0
China
State/province [17] 0 0
Sichuan
Country [18] 0 0
China
State/province [18] 0 0
Tianjin
Country [19] 0 0
China
State/province [19] 0 0
Yunnan
Country [20] 0 0
China
State/province [20] 0 0
Zhejiang
Country [21] 0 0
Georgia
State/province [21] 0 0
Ajaria
Country [22] 0 0
Georgia
State/province [22] 0 0
Tbilisi
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Busan Gwang'yeogsi [Pusan-Kwangyokshi]
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Chungcheongbugdo [Ch'ungch'ongbuk-do]
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Gyeonggido [Kyonggi-do]
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
Country [27] 0 0
Romania
State/province [27] 0 0
Cluj
Country [28] 0 0
Romania
State/province [28] 0 0
Dolj
Country [29] 0 0
Romania
State/province [29] 0 0
Ovidiu
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid
Country [31] 0 0
Spain
State/province [31] 0 0
Barcelona
Country [32] 0 0
Spain
State/province [32] 0 0
Málaga
Country [33] 0 0
Spain
State/province [33] 0 0
Sevilla
Country [34] 0 0
Spain
State/province [34] 0 0
Valencia
Country [35] 0 0
Turkey
State/province [35] 0 0
Adana
Country [36] 0 0
Turkey
State/province [36] 0 0
Ankara
Country [37] 0 0
Turkey
State/province [37] 0 0
Izmir
Country [38] 0 0
Turkey
State/province [38] 0 0
Malatya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Klus Pharma Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05816252
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Xiaoping Jin, PhD
Address 0 0
Country 0 0
Phone 0 0
86-028-67255165
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05816252