A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC

  • STATUS
    Recruiting
  • End date
    Aug 30, 2025
  • participants needed
    60
  • sponsor
    Shanghai Henlius Biotech
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Updated on 7 October 2022
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Summary

This study is conducted in patients with Locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) or esophageal adenosquamous carcinoma. This study includes three arms: A, B1, and B2. Arm A will receive HLX07 combination therapy with HLX10 and Chemotherapy (Cisplatin+5-FU) as first line treatment. Arm B (Patients with EGFR expression H score ≥ 200) and Arm C (Patients with EGFR expression H score < 200) will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

Details
Condition ESCC or Esophageal Adenosquamous Carcinoma
Treatment HLX07, HLX07+HLX10+ Cisplatin+5-FU
Clinical Study IdentifierNCT05221658
SponsorShanghai Henlius Biotech
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subjects who meet all of the following criteria are allowed to be enrolled into this
study
Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures
Age ≥ 18 years and ≤ 75 years when ICF is signed
Histopathologically or cytologically confirmed diagnosis of locally advanced, unresectable or metastatic esophageal squamous cell carcinoma (ESCC) or esophageal adenosquamous carcinoma
Subjects in Arm B1 and Arm B2 must provide eligible tumor tissue for EGFR expression level determination： Arm B1: Subjects with EGFR expression H score ≥ 200 confirmed by central laboratory immunohistochemistry (IHC) in tumor tissue
Arm B2: Subjects with EGFR expression H score < 200 confirmed by central
laboratory IHC
prior therapy: Arm A: Never received systemic anti-tumor drug therapy before. Exception: for patients who have received neoadjuvant/adjuvant treatment, the time from the last treatment to recurrence or progression can be screened for more than 6 months; Arms B1 and B2: Failed or intolerant to prior systemic anti-tumor therapy (at least 2 lines)
According to the curative effect evaluation criteria in solid tumors (RECIST) v1.1, assessed by the investigator with at least one measurable lesions (such as esophageal cavity structure not as measurable lesions), measurable lesions should be not received radiotherapy, etc (lesions located in the usual radiation area, if confirm progress, can also be selected as the target lesion)
Within 7 days before the first use of the study drug, ECOG: 0 ~ 1
Expected survival 12 weeks
The functions of the vital organs meet the following requirements (no blood transfusion, cytokine growth factor, or platelet raising drugs are allowed within 14 days before the first use of the study drugs); Absolute neutrophil count (ANC) ≥1.5×109/L platelet≥ 100×109/L; Hemoglobin≥ 90g/L; Serum albumin≥ 30g/L; Total bilirubin≤ 1.5 ULN, ALT, AST and/or ALP≤ 2.5 ULN;ALT and/or AST≤ 5 ULN in the presence of liver metastasis;If there is liver metastasis or bone metastasis ALP≤ 5 ULN; Serum creatinine ≤1.5 ULN or creatinine clearance > 50 mL/min (Cockcroft-Gault formula); APTT, INR and PT ≤1.5 ULN
For fertile female subjects, the serum pregnancy test must be negative within 7 days before the first dose
With fertile women subjects, and the partner for childbearing age women of male subjects, needs during the therapy, and after the last use HLX10 / placebo at least 6 months and the last time to use at least 6 months after chemotherapy using an approved by the medical contraception (such as intrauterine device, the pill or condoms)

Exclusion Criteria

Subjects who meet any of the following criteria are not allowed to be enrolled in this
study
A history of gastrointestinal perforation and/or fistula within 6 months prior to the first administration
Obvious invasion of tumor into adjacent organs (aorta or trachea) of esophageal lesions leads to high risk of bleeding or fistula;3. Subjects after endotracheal stent implantation
Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage
Previous allergies to monoclonal antibody, HLX10, 5-fu, cisplatin and other platinum drugs
Have received any of the following treatments
A.Prior systemic anti-EGFR monoclonal antibody therapy Previous treatment with anti-pd-1 or
anti-pd-L1 antibodies （Arm A）; B. Have received any research drugs within 4 weeks before
the first use of the study drugs; C. Be enrolled in another clinical study at the same
time, unless it is an observational (non-interventional) clinical study or a follow-up
interventional clinical study; D. Receive the final anticancer treatment within 4 weeks
before the first use of the study drug;Palliative radiotherapy for bone metastases was
allowed and was completed 2 weeks before the first dose.Radiotherapy covering more than 30%
of the bone marrow area is not allowed within 28 days before the first dose
E. Subjects who require systemic treatment with corticosteroids (> 10 mg/ day prednisone
therapeutic dose) or other immunosuppressive agents within 14 days prior to the first use
of the study drug;In the absence of active autoimmune disease, inhalation or topical use of
steroids is permitted, and the therapeutic dose of prednisone 10mg/ day is allowed
F. Those who have received the anti-tumor vaccine or the live vaccine within 4 weeks before
the first dose of the study drug; G. Have undergone major surgery within 28 days prior to
the first use of the study drug. Major surgery in this study is defined as requiring at
least 3 weeks of postoperative recovery time before being able to receive the surgery
treated in this study.Tumor puncture or lymph node biopsy were allowed
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