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

ClinicalTrials.gov ID

NCT07697586

Lead Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.INDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

206Estimated

Last Update Posted

Aug 12, 2026Actual

Start Date

Aug 7, 2026Actual

Primary Completion Date

Aug 2028Estimated

Completion Date

Aug 2029Estimated

Official Title

A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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.

• NSCLC

• SKB264+SKB118

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.INDUSTRY

caicunzhoudr@163.com13301825532

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