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A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy

ConditionNasopharyngeal Carcinoma (NPC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Henlius Biotech

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HLX43 DOSE 1

    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.

  • HLX43 DOSE 2

    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.

  • HLX43 DOSE 3

    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.

Treatment groups

70 Participants
are divided into 3 treatment groups
Group A: HLX43 DOSE 1Experimental treatment 1 intervention
Group B: HLX43 DOSE 2Experimental treatment 1 intervention
Group C: HLX43 DOSE 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

Objective response rate (ORR) (assessed by INV per RECIST v1.1)

Time frame
up to 24 week
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 per RECIST v1.1.

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

Secondary outcomes

1

ORR

Objective response rate (ORR) (assessed by the IRRC per RECIST v1.1)

Time frame
up to 24 week
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 the IRRC per RECIST v1.1.

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
3

OS

Overall Survival

Time frame
From randomization to death from any cause (up to approximately 18 months)
4

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

Time frame
time from the date of the first dose of study drug until 90 days after last dose, assessed up to 18 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
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