Carcinoma of Head and/or NeckPhase 2NCT06857279
A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing HLX43 DOSE 1, HLX43 DOSE 2 and HLX43 DOSE 3 in people with Carcinoma of Head and/or Neck, run by Shanghai Henlius Biotech at 2 sites in China.
Trial summary
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma of Head and/or Neck
- 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
- 167 participants
- Where
- 2 sitesChina
- Study dates
- 22 Apr 2025to 30 Jan 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
- Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
- Cohort 1： Patients with histologically confirmed recurrent/metastatic head and neck squamous cell carcinoma who have been refractory to previous systemic treatment;
- Cohort 2： Patients with histologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), including primary oropharyngeal, oral cavity, hypopharyngeal, or laryngeal carcinoma. Previous treatment must meet the following requirements:
- Have not received systemic anti-tumor therapy for HNSCC in the recurrent or metastatic setting.
- Have not experienced disease progression or recurrence within 6 months after completion of systemic anti-tumor therapy in the locally advanced setting.
- 4. At least one measurable lesion as per RECIST 1.1 within 4 weeks prior to randomization; 5. Subjects who agree to provide archived tumor tissue specimens that meets the testing requirements or agree to undergo a biopsy; 6. The following conditions must be met in terms of the time of the first administration of the investigational product: at least 3 weeks (or 5 half-lives of the drug, whichever is shorter) from the previous major surgery, medical device treatment, locoregional radiotherapy (except for palliative radiotherapy for bone lesions), cytotoxic chemotherapy, immunotherapy, or biological product therapy; at least 2 weeks from the previous hormone therapy or small molecular targeted therapy; at least 1 week from the administration of the traditional Chinese medicine for anti-cancer indications or minor surgery; and recovery of treatment-induced AEs to Grade ≤ 1; 7. ECOG PS score of 0-1 within 1 week prior to randomization; 8. Life expectancy > 3 months; 9. Adequate organ functions as confirmed by laboratory tests within 1 week prior to randomization; 10. Male and female subjects with child-bearing potential must agree to use at least one highly effective contraception method during the study and within at least 6 months after the last dose of the investigational product; female subjects of childbearing age must be negative for pregnancy test within 7 days prior to enrollment.
Who cannot join
- Patients who meet any of the following criteria are not allowed to be enrolled:
- Patients with head and neck tumor who are indicated for locoregional radical treatment;
- Patients with primary nasopharyngeal carcinoma;
- Imaging examination shows that the tumor has invaded or surrounded the large blood vessels of the chest, neck, and pharynx, and there is imaging evidence that entering the study will induce risks of hemorrhage;
- History of any second malignancy within 2 years prior to randomization, ;
- History of adverse events leading to permanent discontinuation of immunotherapy, or occurrence of ≥ Grade 2 immune-related pneumonitis or myocarditis during prior immunotherapy;
Show all 23Show fewer
- Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Patients who have newly diagnosed or clinically symptomatic brain or leptomeningeal metastases, spinal cord compression, or cancerous meningitis, or uncontrolled brain or spinal cord metastases that have been evidenced;
- Patients with previous or current interstitial pneumonia, pneumoconiosis, drug-related pneumonitis, or severe lung function impairment that may interfere with the detection and management of suspected drug-related pulmonary toxicity; patients with radiation pneumonitis within 6 months;
- Patients with any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA Class II or greater heart failure or left ventricular ejection fraction (LVEF) < 50%; (2) unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months (except lacunar infarction, slight cerebral ischemia, or transient ischemic attack); (4) poorly controlled arrhythmia (including QTc intervals ≥ 450 ms for males and ≥ 470 ms for females) (QTc intervals are calculated by Fridericia's formula); (5) poorly-controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg after active treatment);
- Patients with active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to randomization;
- Patients who have used potent CYP2D6 or CYP3A inhibitors or inducers within 2 weeks prior to randomization;
- Patients who have received systemic corticosteroids (prednisone > 10 mg/d or equivalent dose of similar drug) or other immunosuppressants within 2 weeks prior to randomization;
- Patients with known active or suspected autoimmune diseases;
- Patients who have received live vaccine or live attenuated vaccine within 4 weeks prior to randomization;
- Patients who are known to have severe anaphylaxis to macromolecular protein preparations/monoclonal antibodies or are allergic to any component in the formulation of the investigational product;
- Patients with active tuberculosis;
- Patients with a history of immunodeficiency, including human immunodeficiency virus (HIV)-positive or other acquired or congenital immunodeficiencies, or history of organ transplantation;
- Patients with active HBV or HCV infection or HBV/HCV co-infection;
- Pregnant or lactating women;
- Patients who are not suitable for participating in this clinical study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator；
- Prior treatment with any medication targeting topoisomerase I, including chemotherapy or ADCs;
- Radical radiation therapy within 3 months prior to randomization.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, Shandong, 250117
Man Hu, Dr, +86 0531-67626490, mhu@sdfmu.edu.cn
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Chaosu Hu, Dr, +86 21 64175590 1400, hucsu62@yahoo.com
About this study
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Read the detailed description
This study is an open-label phase II clinical study to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). In this study, eligible subjects will be randomized at 1:1:1 ratio, and the patients will be administered with HLX43 at different doses via intravenous infusion.
- Conditions
- Carcinoma of Head and/or Neck
- Being tested
- HLX43 DOSE 1, HLX43 DOSE 2, HLX43 DOSE 3, HLX43 DOSE 2 + HLX10, HLX43 DOSE 3 + HLX10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX43 DOSE 1Drug
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 2Drug
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 3Drug
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.
HLX43 DOSE 2 + HLX10Drug
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.
HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor
HLX43 DOSE 3 + HLX10Drug
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.
HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor.
HLX43 DOSE 2 + HLX10 + HLX07Drug
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.
HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor.
HLX07 is a recombinant humanized anti-EGFR monoclonal antibody.
HLX43 DOSE 3 + HLX10 + HLX07Drug
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.
HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor.
HLX07 is a recombinant humanized anti-EGFR monoclonal antibody.
| 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, 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, 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, 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 |
| HLX43 DOSE 2 + HLX10 | Experimental | Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, 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 + HLX10 |
| HLX43 DOSE 3 + HLX10 | Experimental | Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, 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 + HLX10 |
| HLX43 DOSE 2 + HLX10 + HLX07 | Experimental | Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, 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 + HLX10 + HLX07 |
| HLX43 DOSE 3 + HLX10 + HLX07 | Experimental | Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, 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 + HLX10 + HLX07 |
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 according to the RECIST v1.1 criteria)
Measured: up to 24 weeks
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 according to the RECIST v1.1 criteria.
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 14 months
Secondary outcomes (2)
OS
Overall Survival
Measured: From randomization to death from any cause (up to approximately 36 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, vital signs and clinical laboratory test results
Measured: time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start22 Apr 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma of Head and/or NeckStudies 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
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chaosu Hu, Dr, Principal investigator, Fudan UniversityMan Hu, Dr, Principal investigator, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical SciencesJinming Yu, Principal investigator, handong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical SciencesDongmei Ji, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857279
- Sponsor's protocol ID
- HLX43-HNSCC201
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
- ClinicalTrials.gov ID
- NCT06857279
- Acronym / sponsor ID
- HLX43-HNSCC201
- Conditions
- Carcinoma of Head and/or Neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 4 Mar 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 being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Detailed description
This study is an open-label phase II clinical study to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). In this study, eligible subjects will be randomized at 1:1:1 ratio, and the patients will be administered with HLX43 at different doses via intravenous infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| 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, 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, 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, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) |
| HLX43 DOSE 2 + HLX10 | Experimental | Drug: HLX43 DOSE 2 + HLX10Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) |
| HLX43 DOSE 3 + HLX10 | Experimental | Drug: HLX43 DOSE 3 + HLX10Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) |
| HLX43 DOSE 2 + HLX10 + HLX07 | Experimental | Drug: HLX43 DOSE 2 + HLX10 + HLX07Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) |
| HLX43 DOSE 3 + HLX10 + HLX07 | Experimental | Drug: HLX43 DOSE 3 + HLX10 + HLX07Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, 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 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
- Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
- Cohort 1： Patients with histologically confirmed recurrent/metastatic head and neck squamous cell carcinoma who have been refractory to previous systemic treatment;
- Cohort 2： Patients with histologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), including primary oropharyngeal, oral cavity, hypopharyngeal, or laryngeal carcinoma. Previous treatment must meet the following requirements:
- Have not received systemic anti-tumor therapy for HNSCC in the recurrent or metastatic setting.
Key exclusion criteria (23 listed)
- Patients with head and neck tumor who are indicated for locoregional radical treatment;
- Patients with primary nasopharyngeal carcinoma;
- Imaging examination shows that the tumor has invaded or surrounded the large blood vessels of the chest, neck, and pharynx, and there is imaging evidence that entering the study will induce risks of hemorrhage;
- History of any second malignancy within 2 years prior to randomization, ;
- History of adverse events leading to permanent discontinuation of immunotherapy, or occurrence of ≥ Grade 2 immune-related pneumonitis or myocarditis during prior immunotherapy;
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 1Dose 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. | Drug | HLX43 DOSE 1 |
| HLX43 DOSE 2Dose 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. | Drug | HLX43 DOSE 2 |
| HLX43 DOSE 3Dose 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. | Drug | HLX43 DOSE 3 |
| HLX43 DOSE 2 + HLX10HLX43 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. HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor | Drug | HLX43 DOSE 2 + HLX10 |
| HLX43 DOSE 3 + HLX10HLX43 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. HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor. | Drug | HLX43 DOSE 3 + HLX10 |
| HLX43 DOSE 2 + HLX10 + HLX07HLX43 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. HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor. HLX07 is a recombinant humanized anti-EGFR monoclonal antibody. | Drug | HLX43 DOSE 2 + HLX10 + HLX07 |
| HLX43 DOSE 3 + HLX10 + HLX07HLX43 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. HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor. HLX07 is a recombinant humanized anti-EGFR monoclonal antibody. | Drug | HLX43 DOSE 3 + HLX10 + HLX07 |
Primary outcome
ORR
Time frame: up to 24 weeks
Objective response rate (ORR) (assessed by INV according to the RECIST v1.1 criteria)
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 14 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 according to the RECIST v1.1 criteria.
2 secondary outcomes
OS
Time frame: From randomization to death from any cause (up to approximately 36 months)
Incidence and severity of adverse events (AEs)
Time frame: time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 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 5 Mar 2026.
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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.
Chaosu Hu, Dr principal investigator
Fudan University
Man Hu, Dr principal investigator
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Jinming Yu principal investigator
handong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
2 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 Carcinoma of Head and/or Neck, run by Shanghai Henlius Biotech at 2 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 7 inclusion and 23 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 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Chaosu Hu, Dr (+86 21 64175590 1400, hucsu62@yahoo.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 weeks). 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 5 Mar 2026.