NCT06083870 An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
| NCT ID | NCT06083870 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Lu Shun |
| Condition | Non-small Cell Lung Cancer Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2023-12-13 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 35 participants in total. It began in 2023-12-13 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06083870 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-small Cell Lung Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06083870 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06083870 currently recruiting?
Yes, NCT06083870 is actively recruiting participants. Contact the research team at shunlu@sjtu.edu.cn for enrollment information.
Where is the NCT06083870 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06083870 clinical trial?
NCT06083870 is sponsored by Lu Shun. The trial plans to enroll 35 participants.
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