A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy
NCT ID: NCT06839066
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2025-04-02
2027-11-22
Brief Summary
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Detailed Description
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In this study, eligible subjects will be randomized at 1:1:1 ratio, and the patients will be administered with HLX43 at three different doses via intravenous infusion.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HLX43 DOSE 1
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until disease progression and loss of benifit, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first).
HLX43 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.
HLX43 DOSE 2
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until disease progression and loss of benifit, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first).
HLX43 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.
HLX43 DOSE 3
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until disease progression and loss of benifit, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first).
HLX43 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.
Interventions
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HLX43 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.
HLX43 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.
HLX43 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.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years at the time of signing the ICF, regardless of gender;
3. Histologically or cytologically confirmed recurrent/metastatic nasopharyngeal carcinoma;
4. Recurrent/metastatic nasopharyngeal carcinoma patients who have failed or are intolerant to at least two prior lines of chemotherapy (including at least one platinum-based regimen) and PD-1/PD-L1 inhibitor therapy. Intolerance is defined as experiencing CTCAE ≥ grade 3 adverse events;
5. At least one measurable lesion per RECIST v1.1 within 4 weeks before randomization;
6. Willing to provide archived (preferably within 2 years) or fresh tumor tissue specimens for the detection of PD-L1 expression.
7. At least 4 weeks (or 5 half-lives, whichever is shorter) since last major surgery, medical device treatment, radiotherapy (except palliative bone radiotherapy), cytotoxic chemotherapy, immunotherapy, or biological therapy; ≥2 weeks since last hormonal therapy or small molecule targeted therapy; ≥1 week since last traditional Chinese medicine treatment with anti-tumor indications or minor surgery; with treatment-related adverse events recovered to CTCAE v5.0 ≤ grade 1 (except grade 2 peripheral neuropathy and alopecia);
8. ECOG performance status 0-1 within 1 week before randomization;
9. Expected survival ≥ 3 months；
10. Adequate organ function within 1 week before randomization (no blood transfusion or colony-stimulating factors within 14 days prior to first dose)
11. Fertile participants must use ≥1 highly effective contraceptive method during the trial and for ≥6 months after last dose; females of childbearing potential must have negative pregnancy test within 7 days before enrollment.
Exclusion Criteria
2. Imaging showing tumor invasion/encasement of major thoracic/cervical/pharyngeal blood vessels (may be exempted if investigators confirm no impact on trial participation).
3. History of other malignancies within 2 years prior to randomization (except radically treated early-stage malignancies).
4. Previous ≥Grade 3 immune-related adverse events during immunotherapy.
5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
6. Symptomatic/untreated/progressing CNS or leptomeningeal metastases.
7. History of ≥Grade 3 radiation pneumonitis; steroid-requiring (non-infectious) interstitial lung disease (ILD), current ILD, or ILD unexcludable by imaging; or severe respiratory impairment from pulmonary disease.
8. Poorly controlled cardiovascular/cerebrovascular conditions including.
9. Candidates for organ/marrow transplantation or previous transplant recipients.
10. Active systemic infections requiring IV antibiotics within 2 weeks pre-randomization.
11. Use of strong CYP2D6/CYP3A inhibitors/inducers within 2 weeks pre-randomization.
12. Systemic corticosteroid use (\>10mg prednisone/day equivalent) or immunosuppressants within 2 weeks pre-randomization. Exceptions: Topical/ocular/intra-articular/nasal/inhaled steroids; short-term prophylactic use for contrast agents.
13. Active/suspected autoimmune diseases. Exceptions: Hypothyroid patients on thyroid replacement; controlled type 1 diabetes with insulin.
14. Live/attenuated vaccines within 4 weeks pre-randomization (inactivated influenza vaccines permitted).
15. History of severe hypersensitivity to biologics/monoclonal antibodies or trial drug components.
16. Active tuberculosis.
17. Immunodeficiency disorders (HIV-positive or congenital/acquired immune deficiencies).
18. Active HBV/HCV infection or co-infection:
19. Pregnant/lactating women.
20. Investigators' judgment of clinical/lab abnormalities or other factors making participation inappropriate.
18 Years
ALL
No
Sponsors
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Shanghai Henlius Biotech
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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HLX43-NPC201
Identifier Type: -
Identifier Source: org_study_id
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