Evaluating Oba01 injection for patients with advanced lung cancer
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
This study is testing a new injection called Oba01 to see if it can help people with advanced lung cancer who haven't had success with other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Chest Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06083870 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of Oba01 for injection in patients diagnosed with DR5 positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will be monitored for their response to the treatment following progression after systemic therapy. The study will include patients who have measurable lesions and adequate organ function, ensuring a thorough evaluation of the drug's effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with confirmed DR5 positive locally advanced or metastatic NSCLC who have experienced disease progression after prior systemic treatment.
Not a fit: Patients who have previously received treatment with DR5 targeted regimens or those with untreated brain metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced lung cancer who have limited treatment choices.
How similar studies have performed: While this approach is novel in targeting DR5 in NSCLC, similar studies targeting other pathways have shown promise in treating advanced cancers.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Shun Lu, PhD
- Email: shunlu@sjtu.edu.cn
- Phone: 86-21-62821990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.