An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
NCT ID: NCT06083870
Last Updated: 2023-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
35 participants
INTERVENTIONAL
2023-12-13
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Oba01
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Lu Shun
OTHER
Responsible Party
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Lu Shun
Prof.
Locations
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Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Shun Lu
Role: primary
Other Identifiers
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RC248-C001
Identifier Type: -
Identifier Source: org_study_id