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

August 25, 2022 updated by: Shanghai Henlius Biotech

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Cancer Hospital Chinese Academic of Medical Sciences
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China
      • Xiamen, Fujian, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
    • Guangdong
      • Shenzhen, Guangdong, China
        • Not yet recruiting
        • Cancer Hospital Chinese Academic of Medical Sciences, Shenzhen Center
        • Contact:
    • Hebei
      • Anyang, Hebei, China
        • Not yet recruiting
        • Anyang Cancer Hospital
        • Contact:
      • Xingtai, Hebei, China
        • Not yet recruiting
        • Xingtai People's Hospital
        • Contact:
    • Henan
      • Zhenzhou, Henan, China
        • Not yet recruiting
        • Henan Cancer Hospital & Affiliated Cancer Hospital of Zhengzhou University
        • Contact:
    • Hunan
      • Changsha, Hunan, China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital
        • Contact:
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Jiangsu People Hospital & The First Affiliated with Nanjing Medical University
        • Contact:
      • Xuzhou, Jiangsu, China
        • Not yet recruiting
        • Xuzhou Center Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China
      • Jining, Shandong, China
        • Not yet recruiting
        • Affiliated Hospital of Jining Medical University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • Sichuan Cancer hospital
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China
        • Not yet recruiting
        • Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
As first-line therapy
Drug: HLX07+HLX10+ Cisplatin+5-FU
HLX07 1000mg + HLX10 200mg + Cisplatin 50 mg/m2 + 5-FU 2400mg/m2
Experimental: Arm B1
EGFR H score ≥ 200, as third-line or above therapy
Drug: HLX07
HLX07 1000mg iv Q2w
Experimental: Arm B2
EGFR H score <200, as third-line or above therapy
Drug: HLX07
HLX07 1000mg iv Q2w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: up to 2 years
Objective response rate by IRRC/INV assessment per RECIST
up to 2 years
PFS
Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
Progression-free survival by IRRC/INV assessment per RECIST
from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DOR
Time Frame: from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years
Duration of response
from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years
OS
Time Frame: from the date of first dose unitl the date of death from any cause，assessed up to 2 years
Ooverall survival
from the date of first dose unitl the date of death from any cause，assessed up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Henlius Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2022

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

August 30, 2025

Study Registration Dates

First Submitted

January 22, 2022

First Submitted That Met QC Criteria

January 22, 2022

First Posted (Actual)

February 3, 2022

Study Record Updates

Last Update Posted (Actual)

August 29, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLX07-ESCC201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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