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New treatment option for Non-small Cell Lung Cancer Metastatic
Official title An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
ClinicalTrials.gov ID: NCT06083870
What this study is testing
What is Oba01?
Oba01 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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 people 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.