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Clinical Trials in China / NCT07697586
Recruiting Phase 2

SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer

NCT07697586 · tracked via the Priya Life Science China tracker
Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Phase
Phase 2
Started
2026-08-07
Last updated
2026-08-12

Condition(s) studied

NSCLC

Investigational drug(s) / intervention(s)

SKB264+SKB118

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)

Trial sites (2)

FacilityCityRegionStatus
Jilin Cancer Hospital Jilin City China Not Yet Recruiting
Shanghai East Hospital, Tongji University Shanghai China Recruiting

More Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. trials in China

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Official registry record

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.

View NCT07697586 on ClinicalTrials.gov ↗ ← All trials in China