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Trial Title:
An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
NCT ID:
NCT06083870
Condition:
Non-small Cell Lung Cancer Metastatic
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Oba01
Description:
Oba01 0.15, 0.5, 0.75, 1.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each
21-day cycle
Arm group label:
Oba01
Summary:
This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01
for injection in patients with DR5 positive LA/mNSCLC.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Shun Lu
Phone:
86-21-22200000
Email:
shunlu@sjtu.edu.cn
Start date:
December 13, 2023
Completion date:
July 2026
Lead sponsor:
Agency:
Lu Shun
Agency class:
Other
Source:
Shanghai Chest Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06083870
