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

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

Overview

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

• Drug SKB264+SKB118
  Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.

Primary outcome measures

• Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [Time frame: From enrollment to the end of treatment at 24 months]
• ORR(objective response rate) [Time frame: From enrollment to the end of treatment at 24 months]

Secondary outcome measures (4)

• DCR(Disease control rate ) [Time frame: From enrollment to the end of treatment at 24 months]
• DOR(duration of response ) [Time frame: From enrollment to the end of treatment at 24 months]
• PFS(progression-free survival) [Time frame: From enrollment to the end of treatment at 24 months]
• OS (overall survival) [Time frame: From enrollment to the end of treatment at 24 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

• Jilin Cancer Hospital — Jilin City
• Shanghai East Hospital, Tongji University — Shanghai

Identifiers

NCT: NCT07697586 · SKB264-II-20

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗