An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLu Shun
About this trial
This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Oba01
DrugOba01 0.15, 0.5, 0.75, 1.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Oba01Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
maximal tolerance dose (MTD) of Oba01
Maximum-tolerated dose (MTD) was defined as the highest dose level at which no more than one of six patients experienced DLT during the DLT assessment window.
Time frame
DLT will be evaluated on 21 days of observation periodSecondary outcomes
1
Overall response rate(ORR)
The objective response rate will be mainly analyzed by investigators according to the RECIST 1.1 standard tumor evaluation.
Time frame
Up to approximately 2 years2
Disease control rate (DCR)
Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.
Time frame
Up to approximately 2 years3
Duration of response (DOR)
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.
Time frame
Up to approximately 2 years4
Progression-free survival (PFS)
Progression-free survival (PFS) refers to the time from the date of first dose to the first researcher's evaluation of disease progression or death.
Time frame
Up to approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lu Shun
Lead sponsor
Shanghai Chest Hospital
Sponsor institution
Source ClinicalTrials.gov