RecruitingPhase 1NCT06083870

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

Sponsor

Lu Shun

Enrollment

35 participants

Start Date

Dec 13, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

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.

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.

DRUGOba01

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

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

Shanghai, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT06083870