Cutaneous Squamous Cell CarcinomaPhase 2NCT05238363
The Efficacy and Safety of HLX07 in Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC)
A Phase 2 study testing HLX07 in people with Cutaneous Squamous Cell Carcinoma, run by Shanghai Henlius Biotech at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma
- What is being tested?
- HLX07
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2022to 15 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong, 510515
Changxing Li, MD, 020-61641989, lilichangxing@163.com
About this study
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)
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).
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Being tested
- HLX07
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX07Drug
Also called Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection
HLX07 1500mg ivgtt Q3W
| Study group | Role | What they receive |
|---|---|---|
| HLX07 | Experimental | HLX07 1500mg ivgtt Q3W Receives: Drug: HLX07 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival by independent radiological review committee (IRRC) assessment per RECIST v1.1
Measured: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years
ORR
Objective response rate by IRRC assessment per RECIST v1.1
Measured: up to 2 years
Secondary outcomes (2)
OS
Overall survival
Measured: from the date of first dose unitl the date of death from any cause，assessed up to 2 years
DOR
Duration of response
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start15 Jun 2022
- Primary completion15 May 2023 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238363
- Sponsor's protocol ID
- HLX07-CSCC201
- Status last verified
- Jun 2022
- First submitted
- 7 Feb 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li C, Zeng K, Zhu D, Fan Z, Chen Y, Chen Y, Li Y, Ji M, Duan P, Su J, Yang J, Tang Y, Zhang M, Wang S, Yu G, Huang Y, Chen R, Hu X, Yang F, Yu H, Wang Q, Li J, Zhu J. HLX07, a novel anti-EGFR antibody, for locally advanced and metastatic cutaneous squamous cell carcinoma: an open-label, multicenter, phase II trial. Ther Adv Med Oncol. 2026 Aug 4;18:17588359261456684. doi: 10.1177/17588359261456684. eCollection 2026.
PubMed 42558795
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05238363
- Acronym / sponsor ID
- HLX07-CSCC201
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLX07 | Experimental | Drug: HLX07HLX07 1500mg ivgtt Q3W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX07Also: Recombinant Humanized Anti-EGFR Monoclonal Antibody InjectionHLX07 1500mg ivgtt Q3W | Drug | HLX07 |
Primary outcome
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 independent radiological review committee (IRRC) assessment per RECIST v1.1
ORR
Time frame: up to 2 years
Objective response rate by IRRC assessment per RECIST v1.1
2 secondary outcomes
OS
Time frame: from the date of first dose unitl the date of death from any cause，assessed up to 2 years
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Derived from this study: PubMed 42558795Li C, Zeng K, Zhu D, Fan Z, Chen Y, Chen Y, Li Y, Ji M, Duan P, Su J, Yang J, Tang Y, Zhang M, Wang S, Yu G, Huang Y, Chen R, Hu X, Yang F, Yu H, Wang Q, Li J, Zhu J. HLX07, a novel anti-EGFR antibody, for locally advanced and metastatic cutaneous squamous cell carcinoma: an open-label, multicenter, phase II trial. Ther Adv Med Oncol. 2026 Aug 4;18:17588359261456684. doi: 10.1177/17588359261456684. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX07 in people with Cutaneous Squamous Cell Carcinoma, run by Shanghai Henlius Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Changxing Li, MD (020-61641989, lilichangxing@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05238363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.