An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSC
This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.
| Condition(s) | Non-small Cell Lung Cancer Metastatic |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC. |
| Who can participate | Inclusion Criteria: * Voluntary agreement to provide written informed consent. * Man or woman ≥ 18 years and ≤75 years of age at the time of enrollment. * Histologically and/or cytologically-confirmed locally advanced or metastatic NSCLC. * Measurable lesion according to RECIST 1.1. * Progression after systemic treatment for advanced NSCLC. * Available archived paraffin-embedded or fresh tumor tissue from the primary tumor or metastasis for submission to the central laboratory. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Measurable and/or non-measurable disease as per RECIST 1.1 criteria. * Adequate organ function as assessed by laboratory tests. * Male or female subjects of child-producing potential must agree to use avoidance of pregnancy measures during t |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Lu Shun |
| Locations | Shanghai, China |
| Start date | 2023-12-13 |
| NCT ID | NCT06083870 |
| Official listing | https://clinicaltrials.gov/study/NCT06083870 |