NSCLC
Conditions
Brief summary
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.
Interventions
DRUGSKB264+SKB118
Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.
Sponsors
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | From enrollment to the end of treatment at 24 months | adverse events (AEs) and serious adverse events (SAEs), dose-limiting toxicities (DLTs), clinically significant abnormal laboratory results, etc. |
| ORR(objective response rate) | From enrollment to the end of treatment at 24 months | ORR as assessed by the investigator based on RECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR(Disease control rate ) | From enrollment to the end of treatment at 24 months | as assessed by the investigator based on RECIST v1.1 |
| DOR(duration of response ) | From enrollment to the end of treatment at 24 months | as assessed by the investigator based on RECIST v1.1 |
| PFS(progression-free survival) | From enrollment to the end of treatment at 24 months | as assessed by the investigator based on RECIST v1.1 |
| OS (overall survival) | From enrollment to the end of treatment at 24 months | — |
Countries
China
Contacts
CONTACTYan Qing Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Outcome results
None listed