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
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