Actively Recruiting
Phase 1 Study of Oba01 Injection to Evaluate Safety and Effects in Patients With DR5 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
Led by Lu Shun · Updated on 2023-12-20
35
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, how the body processes, and effectiveness of Oba01 injection in patients with DR5 positive locally advanced or metastatic non-small cell lung cancer (NSCLC). This early phase 1 study focuses on patients who have measurable cancer lesions and whose disease has progressed after systemic treatment. The study includes adults aged 18 to 75 years with confirmed NSCLC and good general health status. Participants receive Oba01 through intravenous infusion at doses ranging from 0.15 to 1.0 mg/kg, administered on Day 1 of each 21-day treatment cycle. The main goal is to find the highest dose patients can tolerate, with close monitoring for dose-limiting toxicities during a 21-day observation period. Treatment cycles may continue based on patient response and safety. Throughout the study, participants will have assessments including tumor measurements following RECIST 1.1 criteria, laboratory tests to check organ function, and monitoring for side effects. Patients must provide tumor tissue samples for laboratory analysis. Safety and response to treatment will be carefully recorded, including the primary outcome of maximal tolerated dose of Oba01. The study requires participants to use pregnancy prevention measures during and for six months after treatment and includes follow-up for adverse events.
CONDITIONS
Official Title
An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, China, 200030
Actively Recruiting
Research Team
S
Shun Lu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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