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
Qualifiers
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
Treatments tested in this trial
- Oba01
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Lu Shun
Lead sponsor
Shanghai Chest Hospital
Sponsor institution
Source ClinicalTrials.gov