SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer
Recruiting · NCT07697586 · Interventional (participants receive a specific treatment) · Lead sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
SKB264+SKB118
What this trial is about
This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- Without epidermal growth factor receptor (EGFR) sensitizing mutation, and anaplastic lymphoma kinase (ALK) fusion gene.
- Provide a tumor tissue sample.
- At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
- ECOG performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Adequate bone marrow, liver, kidney, and coagulation function.
- Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.
Exclusion criteria
- Histologically or cytologically confirmed co-existing small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.
- Participants with known metastases to meninges, brainstem metastases, metastases to spinal cord and/or compression, or active metastases to central nervous system (CNS).
- Uncontrolled systemic disease as judged by the investigator.
- Presence of uncontrolled, clinically symptomatic, or requiring repeated drainage pleural effusion, pericardial effusion, or ascites.
- Presence of other moderate to severe lung disorders.
- History of haemorrhagic diathesis or coagulopathy and/or clinically significant bleeding symptoms or risks.
- Previous or co-existing gastrointestinal diseases, surgery, and wound healing complications.
- Active hepatitis b or hepatitis c or co-infection with HBV and HCV.
- Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.
- Known hypersensitivity to the study drug or any of its components.
- Pregnant or lactating women.
Where it is running
2 locations listed.
- Jilin Cancer Hospital - Jilin City, China
- Shanghai East Hospital, Tongji University - Shanghai, China