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A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy
Led by Shanghai Henlius Biotech · Updated on 2025-11-24
70
Participants Needed
15
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating HLX43, an anti-PD-L1 antibody linked to a potent DNA topoisomerase I inhibitor, in patients with recurrent or metastatic Nasopharyngeal Carcinoma (NPC) who have not responded to or cannot tolerate second-line therapies. This phase II open-label study aims to find the appropriate dose and assess the safety, tolerability, and effectiveness of HLX43 in this patient group. Participants are randomly assigned to one of three HLX43 dose groups. The drug is given through intravenous infusion every three weeks. Treatment continues as long as patients tolerate it well and the disease remains controlled, stopping only if the disease progresses, intolerable side effects occur, another anti-cancer therapy is started, consent is withdrawn, or death occurs. During the study, patients will undergo regular assessments including tumor evaluations to measure response and progression, safety monitoring for adverse effects, and tissue sample collection for PD-L1 expression analysis. The main outcomes measured are the overall response rate within 24 weeks and progression-free survival up to 12 months. Patients will be followed for safety and survival for up to 18 months after treatment starts.
CONDITIONS
Brief Title
A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study, procedures, and possible side effects, and provide informed consent.
- Be 18 years of age or older.
- Have confirmed recurrent or metastatic nasopharyngeal carcinoma.
- Have failed or be intolerant to at least two prior chemotherapy treatments including a platinum-based regimen and PD-1/PD-L1 inhibitor therapy.
- Have at least one measurable tumor lesion according to RECIST v1.1 within 4 weeks before randomization.
- Willing to provide archived or fresh tumor tissue samples for PD-L1 testing.
- Have recovered from prior treatments and meet specified timeframes since last therapies.
- Have an ECOG performance status of 0 or 1 within 1 week before randomization.
- Expected survival of at least 3 months.
- Have adequate organ function without recent blood transfusion or colony-stimulating factors.
- Fertile participants must use effective contraception during the study and for 6 months after; females must have a negative pregnancy test before enrollment.
You will not qualify if you...
- Eligible for curative local therapy such as surgery or radiotherapy.
- Tumor invasion or encasement of major blood vessels affecting trial participation.
- History of other cancers within 2 years, except early-stage treated malignancies.
- Previous grade 3 or higher immune-related adverse events from immunotherapy.
- Uncontrolled pleural, pericardial effusions, or ascites requiring repeated drainage.
- Untreated or progressing brain or leptomeningeal metastases.
- Severe lung conditions including grade 3 radiation pneumonitis or interstitial lung disease.
- Poorly controlled cardiovascular or cerebrovascular diseases.
- Candidates for or previous organ or marrow transplant recipients.
- Active systemic infections requiring intravenous antibiotics recently.
- Recent use of strong CYP2D6/CYP3A inhibitors or inducers.
- Recent systemic corticosteroid or immunosuppressant use, with specified exceptions.
- Active or suspected autoimmune diseases, with some controlled exceptions.
- Recent live or attenuated vaccinations.
- History of severe allergies to biologics or study drug components.
- Active tuberculosis or immunodeficiency disorders.
- Active hepatitis B, C infection or co-infection.
- Pregnant or breastfeeding women.
- Other clinical or laboratory abnormalities making participation unsuitable as judged by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive HLX43 treatment via intravenous infusion once every 3 weeks. Treatment continues until disease progression, intolerable toxicity, initiation of a new anti-tumor therapy, death, or withdrawal of consent.
Visits every 3 weeks for treatment administration
Duration - Up to 18 months after treatment start
Participants are monitored for safety and survival after treatment ends, including assessment of adverse events and overall survival.
Periodic visits for safety and survival assessments
Trial Site Locations
Total: 15 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
2
Dongguan People's Hospital
Dongguan, Guangdong, China
Actively Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
4
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
Actively Recruiting
5
Zhongshan City People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
6
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, China
Actively Recruiting
7
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Actively Recruiting
8
Guizhou Medical University Cancer Hospital
Guiyang, Guizhou, China
Actively Recruiting
9
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Actively Recruiting
10
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
11
Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
12
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Actively Recruiting
13
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Actively Recruiting
14
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
15
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
W
Wenhua Yu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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