An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
Study Details
Study Description
Brief Summary
This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Oba01
|
Drug: Oba01
Oba01 0.15, 0.5, 0.75, 1.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Voluntary agreement to provide written informed consent.
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Man or woman ≥ 18 years and ≤75 years of age at the time of enrollment.
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Histologically and/or cytologically-confirmed locally advanced or metastatic NSCLC.
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Measurable lesion according to RECIST 1.1.
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Progression after systemic treatment for advanced NSCLC.
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Available archived paraffin-embedded or fresh tumor tissue from the primary tumor or metastasis for submission to the central laboratory.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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Measurable and/or non-measurable disease as per RECIST 1.1 criteria.
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Adequate organ function as assessed by laboratory tests.
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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:
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Patient has received previous treatment with DR5 targeted regimen or antibody-MMAE conjugate.
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Brain metastases unless asymptomatic, stable and not requiring steroids for at least 7 days prior to start of study treatment.
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Subject with positive HCV-Ab, Anti-HIV or positive HBS-Ag with copies of HBV DNA > ULN.
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Pregnancy, lactation, or breastfeeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University | Shanghai | China | 200030 |
Sponsors and Collaborators
- Lu Shun
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC248-C001