RecruitingPhase 2NCT06839066

A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy

A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma (NPC) Failed or Intolerance to Second-line Therapy

Sponsor

Shanghai Henlius Biotech

Enrollment

70 participants

Start Date

Apr 2, 2025

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Carcinoma (NPC)

Summary

The study is to explore the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic Nasopharyngeal Carcinoma (NPC) who failed or are intolerant to second-line herapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing HLX43, a new antibody drug, in people with nasopharyngeal carcinoma (a type of head and neck cancer near the back of the nose) that has come back or spread and hasn't responded to prior treatments. **You may be eligible if...** - You are 18 years old or older - You have nasopharyngeal carcinoma confirmed by a lab test that has returned or spread - Your cancer has not responded to or you couldn't tolerate at least two prior chemotherapy regimens, including a platinum-based one, plus a PD-1/PD-L1 immunotherapy - You have at least one measurable tumor on scans - Your general health score (ECOG) is 0 or 1 **You may NOT be eligible if...** - You have active autoimmune disease - You have untreated brain metastases - You have serious heart, liver, or other organ problems - You are pregnant or breastfeeding 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

DRUGHLX43 DOSE 1

HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

DRUGHLX43 DOSE 2

HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

DRUGHLX43 DOSE 3

HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

Locations(15)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Dongguan People's Hospital

Dongguan, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

Zhongshan City People's Hospital

Guangzhou, Guangdong, China

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen

Shenzhen, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Guizhou Medical University Cancer Hospital

Guiyang, Guizhou, China

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06839066

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