Nasopharyngeal Carcinoma (NPC)Phase 2NCT06839066
A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy
A Phase 2 study testing HLX43 DOSE 1, HLX43 DOSE 2 and HLX43 DOSE 3 in people with Nasopharyngeal Carcinoma (NPC), run by Shanghai Henlius Biotech at 15 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- HLX43 DOSE 1, HLX43 DOSE 2 and HLX43 DOSE 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 15 sitesChina
- Study dates
- 2 Apr 2025to 22 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand the study content, procedures, and potential adverse reactions before the trial, sign the informed consent form (ICF), voluntarily participate in the trial, and be able to complete the study per the protocol requirements;
- Age ≥ 18 years at the time of signing the ICF, regardless of gender;
- Histologically or cytologically confirmed recurrent/metastatic nasopharyngeal carcinoma;
- 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;
- At least one measurable lesion per RECIST v1.1 within 4 weeks before randomization;
- Willing to provide archived (preferably within 2 years) or fresh tumor tissue specimens for the detection of PD-L1 expression.
Show all 11Show fewer
- 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);
- ECOG performance status 0-1 within 1 week before randomization;
- Expected survival ≥ 3 months；
- Adequate organ function within 1 week before randomization (no blood transfusion or colony-stimulating factors within 14 days prior to first dose)
- 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.
Who cannot join
- Recurrent nasopharyngeal carcinoma candidates eligible for curative local therapy (surgery or radiotherapy).
- Imaging showing tumor invasion/encasement of major thoracic/cervical/pharyngeal blood vessels (may be exempted if investigators confirm no impact on trial participation).
- History of other malignancies within 2 years prior to randomization (except radically treated early-stage malignancies).
- Previous ≥Grade 3 immune-related adverse events during immunotherapy.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Symptomatic/untreated/progressing CNS or leptomeningeal metastases.
Show all 20Show fewer
- 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.
- Poorly controlled cardiovascular/cerebrovascular conditions including.
- Candidates for organ/marrow transplantation or previous transplant recipients.
- Active systemic infections requiring IV antibiotics within 2 weeks pre-randomization.
- Use of strong CYP2D6/CYP3A inhibitors/inducers within 2 weeks pre-randomization.
- 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.
- Active/suspected autoimmune diseases. Exceptions: Hypothyroid patients on thyroid replacement; controlled type 1 diabetes with insulin.
- Live/attenuated vaccines within 4 weeks pre-randomization (inactivated influenza vaccines permitted).
- History of severe hypersensitivity to biologics/monoclonal antibodies or trial drug components.
- Active tuberculosis.
- Immunodeficiency disorders (HIV-positive or congenital/acquired immune deficiencies).
- Active HBV/HCV infection or co-infection:
- Pregnant/lactating women.
- Investigators' judgment of clinical/lab abnormalities or other factors making participation inappropriate.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
- Recruiting
Dongguan People's Hospital
Dongguan, Guangdong
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
- Recruiting
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
- Recruiting
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong
- Recruiting
Zhongshan City People's Hospital
Guangzhou, Guangdong
- Recruiting
Guizhou Medical University Cancer Hospital
Guiyang, Guizhou
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong
- Recruiting
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: 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
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.
Read the detailed description
This study is an open-label phase II clinical study 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 therapy.
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
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- HLX43 DOSE 1, HLX43 DOSE 2, HLX43 DOSE 3
- Keywords
- HLX43, Nasopharyngeal Carcinoma, anti-PD-L1 ADC
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX43 DOSE 1Drug
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 2Drug
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 3Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| HLX43 DOSE 1 | Experimental | 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). Receives: Drug: HLX43 DOSE 1 |
| HLX43 DOSE 2 | Experimental | 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). Receives: Drug: HLX43 DOSE 2 |
| HLX43 DOSE 3 | Experimental | 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). Receives: Drug: HLX43 DOSE 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate (ORR) (assessed by INV per RECIST v1.1)
Measured: up to 24 week
PFS
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by INV per RECIST v1.1.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes (4)
ORR
Objective response rate (ORR) (assessed by the IRRC per RECIST v1.1)
Measured: up to 24 week
PFS
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by the IRRC per RECIST v1.1.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
OS
Overall Survival
Measured: From randomization to death from any cause (up to approximately 18 months)
Incidence and severity of adverse events (AEs)
severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version [v] 5.0
Measured: time from the date of the first dose of study drug until 90 days after last dose, assessed up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start2 Apr 2025
- Primary completion22 Nov 2026 (estimated)
- Study completion22 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839066
- Sponsor's protocol ID
- HLX43-NPC201
- Status last verified
- Nov 2025
- First submitted
- 18 Feb 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06839066
- Acronym / sponsor ID
- HLX43-NPC201
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- HLX43, Nasopharyngeal Carcinoma, anti-PD-L1 ADC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 22 Nov 2026 (estimated)
- Study completion
- 22 Nov 2027 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is an open-label phase II clinical study 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 therapy.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HLX43 DOSE 1 | Experimental | Drug: HLX43 DOSE 1Patients 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 | Experimental | Drug: HLX43 DOSE 2Patients 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 | Experimental | Drug: HLX43 DOSE 3Patients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Fully understand the study content, procedures, and potential adverse reactions before the trial, sign the informed consent form (ICF), voluntarily participate in the trial, and be able to complete the study per the protocol requirements;
- Age ≥ 18 years at the time of signing the ICF, regardless of gender;
- Histologically or cytologically confirmed recurrent/metastatic nasopharyngeal carcinoma;
- 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;
- At least one measurable lesion per RECIST v1.1 within 4 weeks before randomization;
Key exclusion criteria (20 listed)
- Recurrent nasopharyngeal carcinoma candidates eligible for curative local therapy (surgery or radiotherapy).
- Imaging showing tumor invasion/encasement of major thoracic/cervical/pharyngeal blood vessels (may be exempted if investigators confirm no impact on trial participation).
- History of other malignancies within 2 years prior to randomization (except radically treated early-stage malignancies).
- Previous ≥Grade 3 immune-related adverse events during immunotherapy.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX43 DOSE 1HLX43 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. | Drug | HLX43 DOSE 1 |
| HLX43 DOSE 2HLX43 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. | Drug | HLX43 DOSE 2 |
| HLX43 DOSE 3HLX43 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. | Drug | HLX43 DOSE 3 |
Primary outcome
ORR
Time frame: up to 24 week
Objective response rate (ORR) (assessed by INV per RECIST v1.1)
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by INV per RECIST v1.1.
4 secondary outcomes
ORR
Time frame: up to 24 week
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
OS
Time frame: From randomization to death from any cause (up to approximately 18 months)
Incidence and severity of adverse events (AEs)
Time frame: time from the date of the first dose of study drug until 90 days after last dose, assessed up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
Related trials for Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX43 DOSE 1, HLX43 DOSE 2 and HLX43 DOSE 3 in people with Nasopharyngeal Carcinoma (NPC), run by Shanghai Henlius Biotech at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenhua Yu (+86 17638575068, Wenhua_Yu1@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 24 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.