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

RECRUITINGPHASE2

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

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.

NCT04868162•Shanghai Miracogen Inc.

View on ClinicalTrials.gov

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.

Detailed Description

The study consists of two stages. In Part A, approximately 60 patients will be enrolled to evaluate the safety and preliminarily efficacy of MRG003 at 2.0 and 2.3 mg/kg, to further explore the optimized dose. In Part B, 30 to 50 patients will be enrolled to evaluate the safety and preliminary efficacy of the combination of MRG003 and HX008.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+15 more criteria

Locations (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

April 23, 2021

Primary Completion Date

June 1, 2026

Completion Date

December 1, 2026

Last Updated

July 8, 2025

Enrollment

116

ESTIMATED participants

Conditions

Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

Interventions

MRG003

DRUG

MRG003+HX008

DRUG

Contacts

Program Director

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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