Non-small Cell Lung Cancer Metastatic
Conditions
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.
Interventions
DRUGOba01
Oba01 0.15, 0.5, 0.75, 1.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle
Sponsors
Lu Shun
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maximal tolerance dose (MTD) of Oba01 | DLT will be evaluated on 21 days of observation period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate(ORR) | Up to approximately 2 years | The objective response rate will be mainly analyzed by investigators according to the RECIST 1.1 standard tumor evaluation. |
| Disease control rate (DCR) | Up to approximately 2 years | 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. |
| Duration of response (DOR) | Up to approximately 2 years | DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death. |
| Progression-free survival (PFS) | Up to approximately 2 years | 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. |
| Overall survival (OS) | Up to approximately 2 years | Overall survival (OS) refers to the time from the date of first dose to death. |
Countries
China
Contacts
Primary ContactShun Lu, PhD
Outcome results
None listed