Actively Recruiting
MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinoma
Led by Jiyan Liu · Updated on 2026-04-07
10
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
Sponsors
J
Jiyan Liu
Lead Sponsor
W
West China Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Penile squamous cell carcinoma (PSCC) is a rare malignancy, with stage IV patients exhibiting a 2-year overall survival (OS) rate of 21% and a 5-year survival rate of 0%. Both the National Comprehensive Cancer Network (NCCN) and European Association of Urology (EAU) guidelines recommend chemotherapy as the first-line treatment. However, the efficacy of chemotherapeutic agents in PSCC remains suboptimal, and options after chemotherapy failure are extremely limited. In recent years, targeted therapy and immunotherapy have demonstrated potential in treating this disease. Combination therapies based on chemotherapy, particularly chemoimmunotherapy combined with targeted therapy, have shown promising antitumor effects. Nevertheless, these regimens are associated with significant adverse effects and impose high physical demands on patients. Therefore, this study aims to explore a "highly effective and low-toxicity" first-line treatment regimen for advanced PSCC patients. The objective is to evaluate the combined therapeutic efficacy of an epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (MRG003) and an immune checkpoint inhibitor (HX008) through a single-arm, phase I, prospective clinical trial.
CONDITIONS
Official Title
MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed unresectable, locally advanced, or metastatic penile squamous cell carcinoma
- EGFR expression confirmed by institutional pathology using primary or metastatic tumor tissue
- No prior systemic therapy for advanced disease
- Male aged 18 years or older
- ECOG performance status 0-1 with life expectancy of at least 3 months
- At least one measurable lesion according to RECIST 1.1 criteria
- Adequate organ function including LVEF of 50% or higher; hemoglobin 90 g/L or above; WBC 3.0x10^9/L or above; ANC 1.5x10^9/L or above; platelet count 80x10^9/L or above; total bilirubin no more than 1.5 times upper limit of normal; AST/ALT no more than 2.5 times upper limit (5 times if liver metastases present); serum creatinine no more than 1.5 times upper limit or creatinine clearance at least 50 mL/min
- Willing to provide written informed consent and comply with study procedures and follow-up
You will not qualify if you...
- Prior systemic therapy before enrollment
- History of other cancers except cured carcinoma in situ of cervix, basal cell skin carcinoma, or other cancers disease-free for at least 5 years
- Central nervous system metastases or carcinomatous meningitis; previously treated brain metastases allowed if stable for at least 6 months without progression or symptoms
- Severe or uncontrolled diseases including uncontrolled infections, active tuberculosis, uncontrolled diabetes, serious cardiovascular diseases, pulmonary diseases, recent deep vein thrombosis or pulmonary embolism, or decompensated cirrhosis
- Active autoimmune disease requiring systemic treatment within past 2 years; replacement therapies allowed
- Positive tests for HIV, active hepatitis B or hepatitis C infection
- Major surgery within 4 weeks before enrollment or prior allogeneic stem cell or solid organ transplant
- Use or planned use of anti-cancer vaccines within 4 weeks before enrollment or during study
- Significant pleural effusion or ascites deemed unsuitable by investigator
- Any other condition deemed by investigator to make patient ineligible for the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
H
Hong-Shuai Li, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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