SKB264+SKB118: Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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
Trial sites (2)
Facility
City
Region
Status
Jilin Cancer Hospital
Jilin City
China
Not Yet Recruiting
Shanghai East Hospital, Tongji University
Shanghai
China
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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