An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC

• Status: Recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lu Shun

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.