RecruitingPhase 2NCT05420220

Study of KN046 in Subjects With Advanced Non-Small Cell Lung Cancer

An Open-Label, Multi-Center, Phase 2 Clinical Study to Evaluate Efficacy, Safety, and Tolerability of KN046 in Combination With Axitinib in Subjects With Advanced Non-Small Cell Lung Cancer

Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Enrollment

54 participants

Start Date

Jul 15, 2022

Study Type

INTERVENTIONAL

Conditions

Advanced Non-Small Cell Lung Cancer

Summary

This is an open-label, multi-center, Phase 2 study in subjects with treatment-naïve locally advanced (unresectable and unable to receive radical chemoradiotherapy) or metastatic PD-L1-positive non-small cell lung cancer (NSCLC) who have received systemic therapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a bispecific antibody drug called KN046 — a medication that targets two immune checkpoint proteins (PD-L1 and CTLA-4) at once — for people with advanced non-small cell lung cancer (NSCLC). This dual-target approach may activate the immune system more powerfully to fight cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with non-small cell lung cancer that is locally advanced, metastatic, or recurrent - Your cancer has progressed after standard treatments - You are in reasonably good physical condition - Your organs are functioning well enough (liver, kidneys, blood) **You may NOT be eligible if...** - You have active autoimmune disease requiring treatment - You have had serious side effects from prior immunotherapy drugs - You have uncontrolled brain metastases - You are pregnant or breastfeeding - You have significant heart, lung, or liver problems 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

BIOLOGICALKN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection)

5 mg/kg Q3W IV

COMBINATION_PRODUCTAxitinib

5mg bid po

Locations(6)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Linyi Cancer Hospital

Linyi, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

The first affiliated hospital, Zhejiang university

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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

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NCT05420220

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