Testing MRG003 alone and with HX008 for recurrent or metastatic head and neck squamous cell carcinoma
An Open-Label, Single Arm, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck.
This trial tests MRG003 by itself and combined with the PD‑1 antibody HX008 in people with recurrent or metastatic head and neck squamous cell carcinoma who have received prior standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Miracogen Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04868162 on ClinicalTrials.gov |
What this trial studies
The study has two parts: Part A will enroll about 60 patients to study safety, pharmacokinetics, immunogenicity, and preliminary efficacy of two dose levels of MRG003 (2.0 and 2.3 mg/kg) to help select an optimized dose. Part B will enroll 30–50 patients to study safety and preliminary efficacy of the combination of MRG003 plus HX008. Eligible patients must have histologically confirmed unresectable recurrent or metastatic disease, measurable lesions by RECIST v1.1, and ECOG performance status 0–1, with prior platinum and/or anti‑PD‑1 exposure as specified per part. Key outcomes include adverse events, tumor response by RECIST, drug levels, and immune response measures.
Who should consider this trial
Good fit: Adults with unresectable recurrent or metastatic head and neck squamous cell carcinoma, ECOG 0–1, at least one measurable lesion, and prior platinum and/or PD‑1 therapy (Part A) or at least one prior line of standard therapy (Part B) are ideal candidates.
Not a fit: Patients with poor performance status (ECOG ≥2), significant organ dysfunction, pregnancy, or a history of multiple (≥4) prior systemic anti‑tumor therapies are unlikely to benefit from this study treatment.
Why it matters
Potential benefit: If successful, this could provide a new targeted treatment option for patients with recurrent or metastatic head and neck squamous cell carcinoma who have limited options after standard therapies.
How similar studies have performed: Combining EGFR‑targeted agents or antibody‑drug conjugates with PD‑1 inhibitors has shown promise in early trials for head and neck cancer, but the exact MRG003 plus HX008 combination is novel and still unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willing to sign the ICF and follow the requirements specified in the protocol. * Expected survival time≥3 months. * Patients with histologically confirmed unresectable recurrent or metastatic squamous cell carcinoma of 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 therapy (platinum-based regimen) (Part B) * Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). * ECOG performance score 0 or 1. * Organ functions and coagulation function must meet the basic requirements. * Serum or urine pregnancy test negative within 7 days before the first dose of investigational drug. * Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment. Exclusion Criteria: * History of 4 or more systemic anti-tumor therapies for the recurrent or metastatic squamous cell carcinoma of head and neck. * ≥Grade 2 peripheral neuropathy * Prior anti-tumor therapy with MMAE/MMAF ADCs * BMI≤17 * Expected surgery or any other form of systemic or local anti-tumor therapy. * History of systemic chemotherapy within 3 weeks before the first administration of the investigational drug, targeted small molecule therapy within 2 weeks or 5 half-life periods before the first administration (whichever is shorter), antitumor biological therapy or immunotherapy within 4 weeks before the first administration, or major surgery. * Known active CNS metastasis and/or cancerous meningitis. * Residual toxicity reactions caused by previous anti-tumor treatment or abnormal values of laboratory tests higher than grade 1 (CTCAE v5.0). Prior Grade 3 to 4 immune-related AE (irAE) or ≥Grade 2 heart-related irAE. * Uncontrolled or poorly controlled heart disease. * History of pulmonary embolism or deep vein thrombosis within 3 months before the first administration of the investigational drug. * Known history of malignancy. * History of severe dermatosis. * Uncontrolled or poorly controlled hypertension. * Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy. * Known allergic reaction to any ingredients or excipients of investigational drugs. * Known active hepatitis B or C. * Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or solid organ transplantation. * Active bacterial, viral, fungal, rickettsia, or parasitic infections that require systemic anti-infective treatment. * Vaccination of live virus vaccine within 30 days before the first administration of the study drug. Inactivated seasonal influenza vaccine or approved COVID-19 vaccine is allowed. * History of previous or concurrent interstitial pneumonia, radiation pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary dysfunction, symptomatic bronchospasm, etc. * Patients receiving immunology-based treatment for any reason. * Uncontrolled pleural effusion, pericardial effusion or recurrent ascites. * Potent CYP3A4 inhibitors or inducers are in use and cannot be discontinued. * Women who are lactating or pregnant. * Other conditions that in the clinical judgement of the investigator make the patient not suitable for participation in this study.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Ye Guo, Doctor — Shanghai East Hospital
- Study coordinator: Program Director
- Email: clinicaltrials@miracogen.com.cn
- Phone: 86-21-61637960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.