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

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This early-stage study tests a new drug called Oba01 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose cancer has continued to grow after prior treatment. Oba01 targets a protein called DR5 that is found on cancer cells and can trigger cell death. **You may be eligible if...** - You are between 18 and 75 years old - You have locally advanced or metastatic NSCLC confirmed by biopsy - Your cancer has progressed after prior systemic treatment - You have measurable disease visible on imaging - Your overall health is good (ECOG 0 or 1) - Your organ function is adequate - You agree to use contraception for 6 months after last treatment if of childbearing potential **You may NOT be eligible if...** - You have previously been treated with a DR5-targeted drug or a specific type of antibody-drug conjugate - You have brain metastases that are active, symptomatic, or require steroids - You have active hepatitis C, HIV, or active hepatitis B - You are pregnant, breastfeeding, or lactating Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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


Locations(1)

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

Shanghai, China

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NCT06083870


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