Non-small Cell Lung Cancer Metastatic Clinical Trial
Official title:
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.
Status | Recruiting |
Enrollment | 35 |
Est. completion date | July 2026 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 the study and for 6 months after the last day of treatment. Exclusion Criteria: - Patient has received previous treatment with DR5 targeted regimen or antibody-MMAE conjugate. - Brain metastases unless asymptomatic, stable and not requiring steroids for at least 7 days prior to start of study treatment. - Subject with positive HCV-Ab, Anti-HIV or positive HBS-Ag with copies of HBV DNA > ULN. - Pregnancy, lactation, or breastfeeding. |
Country | Name | City | State |
---|---|---|---|
China | Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Lu Shun |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | maximal tolerance dose (MTD) of Oba01 | Maximum-tolerated dose (MTD) was defined as the highest dose level at which no more than one of six patients experienced DLT during the DLT assessment window. | DLT will be evaluated on 21 days of observation period | |
Secondary | Overall response rate(ORR) | The objective response rate will be mainly analyzed by investigators according to the RECIST 1.1 standard tumor evaluation. | Up to approximately 2 years | |
Secondary | Disease control rate (DCR) | Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study. | Up to approximately 2 years | |
Secondary | Duration of response (DOR) | DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death. | Up to approximately 2 years | |
Secondary | Progression-free survival (PFS) | Progression-free survival (PFS) refers to the time from the date of first dose to the first researcher's evaluation of disease progression or death. | Up to approximately 2 years | |
Secondary | Overall survival (OS) | Overall survival (OS) refers to the time from the date of first dose to death. | Up to approximately 2 years |
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