Actively Recruiting
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
Led by Shanghai Miracogen Inc. · Updated on 2025-07-08
116
Participants Needed
1
Research Sites
292 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 and the combination of MRG003 and HX008 in patients with recurrent or metastatic squamous cell carcinoma of head and neck.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign the informed consent form and follow study requirements
- Expected survival time of at least 3 months
- Histologically confirmed unresectable recurrent or metastatic squamous cell carcinoma of the head and neck
- Failed prior platinum and/or anti-PD-1 treatment (Part A); failed or intolerant to at least one prior line of standard platinum-based therapy (Part B)
- At least one measurable lesion according to RECIST v1.1
- ECOG performance score of 0 or 1
- Basic organ and coagulation functions within required limits
- Negative serum or urine pregnancy test within 7 days before first dose
- Use of effective contraception during treatment and for 6 months after last dose if of childbearing potential
You will not qualify if you...
- History of 4 or more systemic anti-tumor therapies for the current cancer
- Peripheral neuropathy of grade 2 or higher
- Previous treatment with MMAE/MMAF antibody-drug conjugates
- Body mass index less than 17
- Planned surgery or other systemic or local anti-tumor therapy during study
- Recent systemic chemotherapy, targeted therapy, immunotherapy, or major surgery within specified timeframes before first dose
- Known active central nervous system metastasis or cancerous meningitis
- Residual toxicity from prior treatments above grade 1 or severe immune-related adverse events
- Uncontrolled or poorly controlled heart disease or hypertension
- Recent pulmonary embolism or deep vein thrombosis
- History of other malignancies
- Severe skin diseases
- Active bleeding, coagulopathy, or use of coumarin anticoagulants
- Known allergies to study drug ingredients
- Active hepatitis B or C infection
- Severe uncontrolled infections or HIV/AIDS
- Uncontrolled autoimmune disease or history of transplantation
- Active infections requiring systemic treatment
- Live virus vaccination within 30 days before first dose
- History of severe pulmonary conditions
- Receiving immunology-based treatments
- Uncontrolled pleural, pericardial effusion or ascites
- Use of potent CYP3A4 inhibitors or inducers that cannot be stopped
- Pregnant or lactating women
- Other conditions judged by the investigator to be unsuitable for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200123
Actively Recruiting
Research Team
P
Program Director
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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