Health TrialsbyHealthPanel

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

ConditionCarcinoma of Head and/or Neck
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Henlius Biotech

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Have not received systemic anti-tumor therapy for HNSCC in the recurrent or metastatic setting.

Disqualifiers

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, ;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 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 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 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 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 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 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.

Treatment groups

167 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: HLX43 DOSE 1Experimental treatment 1 intervention
Group B: HLX43 DOSE 2Experimental treatment 1 intervention
Group C: HLX43 DOSE 3Experimental treatment 1 intervention
Group D: HLX43 DOSE 2 + HLX10Experimental treatment 1 intervention
Group E: HLX43 DOSE 3 + HLX10Experimental treatment 1 intervention
Group F: HLX43 DOSE 2 + HLX10 + HLX07Experimental treatment 1 intervention
Group G: HLX43 DOSE 3 + HLX10 + HLX07Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

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

Time frame
up to 24 weeks
2

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.

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

Secondary outcomes

1

OS

Overall Survival

Time frame
From randomization to death from any cause (up to approximately 36 months)
2

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Henlius Biotech

Lead sponsor

Source ClinicalTrials.gov
Apply now