Clinical trial NCT05238363: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cutaneous Squamous Cell Carcinoma
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2022-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. 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;
2. Aged ≥ 18 years.
3. Histopathologically or cytologically confirmed diagnosis of locally advanced or metastatic Cutaneous Squamous Cell Carcinoma (CSCC).
4. Measurable lesion according to RECIST v1.1 by IRRC.
5. ECOG score 0-1.
6. Expected survival 12 weeks.
7. For fertile female subjects, the pregnancy test must be negative within 7 days before the first dose.

Exclusion Criteria:

1. Prior systemic anti-EGFR monoclonal antibody therapy.
2. 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.
3. 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.
4. Participants with any prior allogeneic solid organ or bone marrow transplantations.
5. 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).
6. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage.
7. Active clinical severe infection.

Primary outcomes:
measure: PFS
timeFrame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years
measure: ORR
timeFrame: up to 2 years
Secondary outcomes:
measure: OS
timeFrame: from the date of first dose unitl the date of death from any cause，assessed up to 2 years
measure: DOR
timeFrame: 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
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
References: