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RECRUITINGPhase 1INTERVENTIONAL

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

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Voluntary agreement to provide written willing to sign a consent form. - 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. - your organs (liver, kidneys, etc.) are working well enough based on blood tests 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Oba01

Oba01 0.15, 0.5, 0.75, 1.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle

Locations (1)

Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, China