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Status unknownNCT05238363Updated Jun 21, 2022

The Efficacy and Safety of HLX07 in Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC)

A Phase 2 interventional study of HLX07 in Cutaneous Squamous Cell Carcinoma, sponsored by Shanghai Henlius Biotech. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-21.

Sponsored by Shanghai Henlius Biotech · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Cutaneous Squamous Cell Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 20 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Shanghai Henlius Biotech is the lead sponsor of 127 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    HLX07

    HLX07 1500mg ivgtt Q3W

    Drug: HLX07

Interventions

  • DrugHLX07

    HLX07 1500mg ivgtt Q3W

    Also known as: Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection

06

What researchers measure

Primary outcomes

  1. PFS

    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

  2. ORR

    Objective response rate by IRRC assessment per RECIST v1.1

    Time frame: up to 2 years

Secondary outcomes

  1. OS

    Overall survival

    Time frame: from the date of first dose unitl the date of death from any cause，assessed up to 2 years

  2. DOR

    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

07

Study locations

1 of 1 sites recruiting
  • Nanfang Hospital
    Guangzhou, Guangdong 510515, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05238363
Lead sponsor
Shanghai Henlius Biotech
Responsible party
Sponsor
First posted
Feb 14, 2022
Start date
Jun 15, 2022
Primary completion
May 15, 2023 (estimated)
Completion
Jul 15, 2024 (estimated)
Last update
Jun 21, 2022

Study contacts

Changxing Li, MD
Contact
lilichangxing@163.com
020-61641989

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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