Status:
RECRUITING
An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
Lead Sponsor:
Lu Shun
Conditions:
Non-small Cell Lung Cancer Metastatic
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06083870
Start Date
December 13 2023
End Date
July 1 2026
Last Update
December 20 2023
Active Locations (1)
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1
Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, China, 200030