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A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy

ConditionEsophageal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Henlius Biotech

About this trial

The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent/Metastatic Esophageal Squamous Cell Carcinomar (ESCC) Failed or Intolerance to Standard First-Line Therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Volunteer to participate in clinical research; To fully understand and understand this study and to sign the Informed Consent Form (ICF); Willing to follow and able to complete all test procedures;

The age of signing ICF is ≥ 18 years old and ≤ 75 years old;

Esophageal Squamous Cell Carcinoma (ESCC) confirmed by histopathology or cytology;

Patients with advanced esophageal squamous cell carcinoma who have failed or are intolerant to prior first-line standard therapy (for patients with PD-L1 expression positive [CPS ≥1], first-line standard therapy is defined as platinum-based chemotherapy and immune checkpoint inhibitor [ICI] therapy; for patients with PD-L1 expression negative [CPS <1], first-line standard therapy is defined as platinum-based chemotherapy). Intolerable toxicity refers to the occurrence of CTCAE grade ≥3 adverse events.;

Disqualifiers

History of any second malignant tumor within the first 2 years prior to randomization;

BMI <17.5 kg/m2；

Symptomatic, untreated, or progressively worsening central nervous system (CNS) or leptomeninges metastases;

After appropriate intervention, uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HLX43

    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

102 Participants
are divided into 4 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
Group D: HLX43 DOSE 4Experimental 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 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 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

ORR

Objective response rate (ORR) (assessed by the IRRC 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 the IRRC 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
3

OS

Overall Survival

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