A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

NCT06857279 | Recruiting Phase 2

• 1 other identifier: HLX43-HNSCC201
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Carcinoma of Head and/or Neck

Outcome Measures

Primary Outcomes (2)

• ORR

  Objective response rate (ORR) (assessed by INV according to the RECIST v1.1 criteria)

  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.

  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

  From randomization to death from any cause (up to approximately 36 months)

• Incidence and severity of adverse events (AEs)

  time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months

Study Arms (7)

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)

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)

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)

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)

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)

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)

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)

Drug: HLX43 DOSE 3 + HLX10 + HLX07

Interventions

HLX43 DOSE 1 DRUG

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 1

HLX43 DOSE 2 DRUG

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 2

HLX43 DOSE 3 DRUG

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 3

HLX43 DOSE 2 + HLX10 DRUG

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

HLX43 DOSE 3 + HLX10 DRUG

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 + HLX10

HLX43 DOSE 2 + HLX10 + HLX07 DRUG

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 2 + HLX10 + HLX07

HLX43 DOSE 3 + HLX10 + HLX07 DRUG

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 + HLX07

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (2)

Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences

Jinan, Shandong, 250117, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Interventions

HLX07

Study Officials

• Chaosu Hu, Dr

  Fudan University

  PRINCIPAL INVESTIGATOR

• Man Hu, Dr

  Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Jinming Yu

  handong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Dongmei Ji

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chaosu Hu, Dr

CONTACT

+86 21 64175590 1400; hucsu62@yahoo.com

Man Hu, Dr

CONTACT

+86 0531-67626490; mhu@sdfmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 4, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): January 30, 2029
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CN (2)