A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria
- Subjects must be at least 18 years of age on day of signing informed consent, regardless of gender;
- Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC ;
- 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;
- 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;
- Subjects are able to provide tumor blocks or slides before the first dose of study intervention;
- Subject must have at least one radiographically measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria;
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1;
- Life expectancy at least 3 months for the subject;
- Adequate organ function;
- Subjects must have recovered from all toxicities led by prior treatment;
- Contraceptive methods used by male and female subjects must comply with contraceptive methods of local regulations for clinical study subjects;
- 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
Exclusion Criteria
- Subjects with mixed SCLC histopathological features;
- Subjects with a known history of prior malignancy;
- Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active central nervous system (CNS) metastases;
- Subjects with ≥ Grade 2 peripheral neuropathy;
- Subjects who had arteriovenous thromboembolic events;
- Subjects with active inflammatory bowel disease or previous clear history of inflammatory bowel disease;
- Subjects who suffer from cardiovascular diseases of clinical significance;
- Subjects with a history of interstitial lung disease (ILD)/non-infectious pneumonitis that required steroids;
- Subjects with uncontrolled systemic disease as judged by the Investigator;
- Subjects with active autoimmune disease that required systemic treatment in the past 2 years;
- Subjects with active hepatitis B or hepatitis C;
- Subjects with known history of Human Immunodeficiency Virus (HIV)
- Subjects with known active tuberculosis;
- Subjects with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study;
- Subjects whose condition deteriorated rapidly, such as severe changes in performance status, during the screening process prior to the first dose of study intervention;
- Subjects with other circumstances that, in the opinion of the Investigator, are not appropriate for participation in this study.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Non-small Cell Lung Cancer
Age
18+
Phase
PHASE2
Participants Needed
278
Est. Completion Date
Aug 31, 2026
Treatment Type
INTERVENTIONAL
Sponsor
Klus Pharma Inc.
ClinicalTrials.gov NCT Identifier
NCT05816252
Study Number
SKB264-II-04
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?