Back to resultsThe Efficacy and Safety of HLX07 in Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC)
Primary Purpose
Cutaneous Squamous Cell Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HLX07
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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;
- Aged ≥ 18 years.
- Histopathologically or cytologically confirmed diagnosis of locally advanced or metastatic Cutaneous Squamous Cell Carcinoma (CSCC).
- Measurable lesion according to RECIST v1.1 by IRRC.
- ECOG score 0-1.
- Expected survival 12 weeks.
- For fertile female subjects, the pregnancy test must be negative within 7 days before the first dose.
Exclusion Criteria:
- Prior systemic anti-EGFR monoclonal antibody therapy.
- A history of other malignancies within three years, except for cured cervical carcinoma in situ, adenocarcinoma in situ of the breast, or tumors that do not require interventional treatment after radical surgery.
- Participant has any other histologic type of skin cancer, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen's disease, MCC, melanoma.
- Participants with any prior allogeneic solid organ or bone marrow transplantations.
- Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage.
- Active clinical severe infection.
Sites / Locations
- Nanfang HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HLX07
Arm Description
HLX07 1500mg ivgtt Q3W
Outcomes
Primary Outcome Measures
PFS
Progression-free survival by independent radiological review committee (IRRC) assessment per RECIST v1.1
ORR
Objective response rate by IRRC assessment per RECIST v1.1
Secondary Outcome Measures
OS
Overall survival
DOR
Duration of response
Full Information
NCT ID
NCT05238363
First Posted
February 7, 2022
Last Updated
June 15, 2022
Sponsor
Shanghai Henlius Biotech
1. Study Identification
Unique Protocol Identification Number
NCT05238363
Brief Title
The Efficacy and Safety of HLX07 in Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC)
Official Title
A Single-arm, Open-Label, Multicenter Phase II Clinical Study to Evaluate Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Patients With Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
July 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Following basal cell carcinoma, Cutaneous Squamous Cell Carcinoma (CSCC) is the most common skin cancer and its incidence remains on a steady rise. The vast majority of CSCC lesions are treated with surgical resection and have a cure rate exceeding 90 percent in early-stage disease. In stark contrast, the 5-year overall survival rate is below 50% for locally advanced patients and less than 10 percent for those with distant metastases. Although the commonly used cisplatin-based combination chemotherapies may achieve an overall response rate of up to 80%, the efficacy is usually not durable. Moreover, the use of chemotherapy is limited due to the many adverse events, especially in elderly patients, who are the largest population of concern for CSCC. The purpose of this study was to assess safety, efficacy in patients with locally advanced or metastatic CSCC given HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HLX07
Arm Type
Experimental
Arm Description
HLX07 1500mg ivgtt Q3W
Intervention Type
Drug
Intervention Name(s)
HLX07
Other Intervention Name(s)
Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection
Intervention Description
HLX07 1500mg ivgtt Q3W
Primary Outcome Measure Information:
Title
PFS
Description
Progression-free survival by independent radiological review committee (IRRC) assessment per RECIST v1.1
Time Frame
from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years
Title
ORR
Description
Objective response rate by IRRC assessment per RECIST v1.1
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
OS
Description
Overall survival
Time Frame
from the date of first dose unitl the date of death from any cause，assessed up to 2 years
Title
DOR
Description
Duration of response
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Aged ≥ 18 years.
Histopathologically or cytologically confirmed diagnosis of locally advanced or metastatic Cutaneous Squamous Cell Carcinoma (CSCC).
Measurable lesion according to RECIST v1.1 by IRRC.
ECOG score 0-1.
Expected survival 12 weeks.
For fertile female subjects, the pregnancy test must be negative within 7 days before the first dose.
Exclusion Criteria:
Prior systemic anti-EGFR monoclonal antibody therapy.
A history of other malignancies within three years, except for cured cervical carcinoma in situ, adenocarcinoma in situ of the breast, or tumors that do not require interventional treatment after radical surgery.
Participant has any other histologic type of skin cancer, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen's disease, MCC, melanoma.
Participants with any prior allogeneic solid organ or bone marrow transplantations.
Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage.
Active clinical severe infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changxing Li, MD
Phone
020-61641989
Email
lilichangxing@163.com
Facility Information:
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changxing Li, MD
Phone
020-61641989
Email
lilichangxing@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy and Safety of HLX07 in Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC)
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