A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

NCT04868162 | Recruiting Phase 2

• 1 other identifier: MRG003-004
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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

Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

Keywords

MRG003; Squamous Cell Carcinoma of Head and Neck; EGFR; HX008; PD-1

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) by Investigator per RECIST v1.1

  ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1.

  Baseline to study completion (up to 24 months)

Secondary Outcomes (10)

• Disease Control Rate (DCR)

  Baseline to study completion (up to 24 months)

• Duration of Response (DoR)

  Baseline to study completion (up to 24 months)

• Progression Free Survival (PFS) as assessed by investigator

  Baseline to study completion (up to 24 months)

• Overall Survival (OS)

  Baseline to study completion (up to 24 months)

• Adverse Events (AEs)

  Baseline to 30 days after the last dose of study treatment

Study Arms (1)

Experimental Arm

EXPERIMENTAL

MRG003 monotherapy will be administered for patients enrolled into Part A of this study; MRG003 and HX008 combination will be administered for patients enrolled into Part B of this study.

Drug: MRG003; Drug: MRG003+HX008

Interventions

MRG003 DRUG

On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg or 2.3 mg/kg.

Experimental Arm

MRG003+HX008 DRUG

On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg or the recommended dose by SMC; and HX008 will be administered via intravenous infusion at 3.0 mg/kg

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Ye Guo, Doctor

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director

CONTACT

86-21-61637960; clinicaltrials@miracogen.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: April 30, 2021
• Study Start: April 23, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)