Clinical trial · Interventional
SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer
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
NCT07697586CI-TRIAL-00121604recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SKB264+SKB118 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SKB264 in combination with SKB118
- description
- SKB264 at 4 mg/kg combined with SKB118 at 3 mg/kg, 10 mg/kg, 20 mg/kg, or other dose levels
- interventionNames
- Drug: SKB264+SKB118
Primary outcomes (2)
- measure
- Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
- timeFrame
- From enrollment to the end of treatment at 24 months
- description
- adverse events (AEs) and serious adverse events (SAEs), dose-limiting toxicities (DLTs), clinically significant abnormal laboratory results, etc.
- measure
- ORR(objective response rate)
- timeFrame
- From enrollment to the end of treatment at 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.