Home › Trials › NCT05221658

Evaluating HLX07 therapy for advanced esophageal cancer

An Open-label, Multicenter , Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 ( Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) Combination Therapy or Monotherapy in Patients With Locally Advanced, Unresectable or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

Phase 2 Interventional Shanghai Henlius Biotech · NCT05221658

This study is testing a new treatment called HLX07 for people with advanced esophageal cancer to see if it works better when combined with other therapies or used alone.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorShanghai Henlius Biotech Industry-sponsored
Drugs / interventionschemotherapy, radiation, prednisone
Locations17 sites (Beijing, Beijing and 16 other locations)
Trial IDNCT05221658 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of HLX07 in patients with advanced esophageal squamous cell carcinoma (ESCC) or esophageal adenosquamous carcinoma. The study includes three treatment arms: Arm A receives HLX07 in combination with HLX10 and chemotherapy, while Arms B1 and B2 receive HLX07 monotherapy based on EGFR expression levels. Patients will be treated until they experience loss of clinical benefit, unacceptable toxicity, or other specified criteria. The trial aims to determine the effectiveness of these therapies in managing advanced stages of ESCC.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced, unresectable, or metastatic ESCC or esophageal adenosquamous carcinoma.

Not a fit: Patients who have already received systemic anti-tumor drug therapy or are outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced esophageal cancer.

How similar studies have performed: Other studies have shown promise with similar therapies, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Beijing, Beijing and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ESCC or Esophageal Adenosquamous Carcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.