An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC

Study Overview
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Brief Summary
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This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.

Official Title
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A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC

Conditions
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Non-small Cell Lung Cancer Metastatic

Intervention / Treatment
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* Drug: Oba01


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oba01<br> | Drug: Oba01<br>* Oba01 0.15, 0.5, 0.75, 1.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Overall survival (OS) | Overall survival (OS) refers to the time from the date of first dose to death. | Up to approximately 2 years |