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

Summary

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

Eligibility

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.

Conditions3

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