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

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

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.

Conditions3

Interventions1

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