A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma

NCT05126719 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: MRG003-005
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 23

Brief Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with recurrent metastatic nasopharyngeal carcinoma.

Conditions

Recurrent or Metastatic Nasopharyngeal Carcinoma

Keywords

MRG003; Antibody Drug Conjugate (ADC); Nasopharyngeal Carcinoma.; EGFR

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) by Independent Review Committee (IRC)

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

  Baseline to disease progression, intolerable drug-related toxicities, withdrawal of consent, or study discontinuation for any reasons (up to 24 months)

Secondary Outcomes (13)

• Objective Response Rate (ORR) by Investigator

  Baseline to Baseline to disease progression, intolerable drug-related toxicities, withdrawal of consent, or study discontinuation for any reasons (up to 24 months)

• Progression Free Survival (PFS)

  Baseline to Baseline to disease progression, intolerable drug-related toxicities, withdrawal of consent, or study discontinuation for any reasons (up to 24 months)

• Duration of Response (DoR)

  Baseline to Baseline to disease progression, intolerable drug-related toxicities, withdrawal of consent, or study discontinuation for any reasons (up to 24 months)

• Disease Control Rate (DCR)

  Baseline to Baseline to disease progression, intolerable drug-related toxicities, withdrawal of consent, or study discontinuation for any reasons (up to 24 months)

• Overall Survival (OS)

  Sign the informed consent form to Baseline to disease progression, intolerable drug-related toxicities, withdrawal of consent, or study discontinuation for any reasons (up to 24 months)

Study Arms (2)

MRG003

EXPERIMENTAL

Part A: 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 calculated based on the actual body weight. Part B: On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.3 mg/kg calculated based on the actual body weight.

Drug: MRG003

Capecitabine tablets/Docetaxel injection

ACTIVE COMPARATOR

Part B: Capecitabine tablets: 1000 mg/m2, bid, d1-14, po, Q3W, or Docetaxel injection: 75 mg/m2, d1, IV, Q3W

Drug: Capecitabine tablets; Drug: Docetaxel injection

Interventions

Docetaxel injection DRUG

Administered intravenously

Capecitabine tablets/Docetaxel injection

MRG003 DRUG

Administered intravenously

MRG003

Capecitabine tablets DRUG

Administered peros

Capecitabine tablets/Docetaxel injection

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.
• Age: ≥18 years, ≤75 years
• Expected survival time\>3 months.
• Patients with histologically confirmed unresectable, radiation-ineligible recurrent metastatic nasopharyngeal carcinoma.
• Part A: Metastatic nasopharyngeal carcinoma that has failed or recurred or was intolerant to at least 1 prior line platinum-based systemic chemotherapy and PD-1/PD-L1 inhibitors
• Part B: have documented failure of at least 2 prior lines of PD-1 (L1) and therapysystemic chemotherapy, which include at least platinum-based regimen, gemcitabine, taxanes/capecitabine.
• Patients must have measurable lesions 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.
• No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%.
• Serum or urine pregnancy test negative within 72 hours 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:

• Grade ≥2 peripheral neuropathy per CTCAE v5.0.
• Is expected to require surgery or any other form of systemic or local anti-tumor therapy during the study.
• Received systemic chemotherapy, targeted therapy, biologics or immunotherapy, or major surgery (except for minor surgery within 2 weeks and fully recovered) within 3 weeks prior to the first dose of study treatment; received thoracic radiotherapy \>30 Gy within 6 months prior to the first dose of study treatment; received prior radiotherapy (except radiotherapy for CNS, wash-out period ≥ 28 days is required) within 14 days before the first dose of study treatment, received traditional Chinese medicine with anti-tumor indications within the 2 weeks before the first dose of study treatment.
• Known active central nervous system (CNS) metastases and/or meningeal metastases. Patients with brain metastases may participate provided they are treated and stable
• Residual toxicities due to prior anti-tumor therapy (including biologics, targeted therapy, immunotherapy, chemotherapy or radiotherapy) or ≥ Grade 1 (CTCAE v5.0) clinically significant laboratory abnormality.
• History of severe cardiac dysfunction, stroke, or transient ischemic attack (TIA) within 6 months prior to enrollment. History of ventricular tachycardia or torsades de pointes. Any clinically important abnormality in the rhythm, conduction, or morphology of the resting ECG. Note: Patients with arrhythmia are eligible if they are receiving antiarrhythmic medication and the screening electrocardiogram (ECG) shows controllable rhythm and heart rate.
• Pulmonary embolism or deep venous thrombosis within 3 months prior to the first dose of study drug.
• Known history of malignancy (except for patients with cutaneous basal cell carcinoma, superficial bladder carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, or papillary thyroid carcinoma who have undergone successful curative treatment) unless the patient has received potentially curative therapy and has not had disease recurrence within 5 years starting from the treatment.
• Note: The 5-year recurrence-free time requirement does not apply to NPC for which the patient is enrolled.
• Uncontrolled or poorly controlled hypertension (e.g., systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg) or diabetes mellitus (glycosylated hemoglobin (HbA1c) \> 8%).
• Patients with active bleeding, history of coagulopathy, or receiving coumarin anticoagulant therapy.
• History of ≥ Grade 3 immune-related AEs (irAEs), including skin toxicity, diarrhea, enteritis, fatigue, immune-related nephritis, immune-related hepatitis, and infusion reactions.
• Known allergic reactions to any component or excipients of MRG003 (citric acid monohydrate, sodium citrate dihydrate, trehalose dihydrate, sodium chloride, and polysorbate 80) or capecitabine/docetaxel, or known allergic reactions to other anti-EGFR agents (including investigational drug) or to other monoclonal antibodies ≥ Grade 3.
• Known active hepatitis B or C. Presence of other serious liver diseases, including chronic autoimmune hepatic disorders, primary biliary cirrhosis or sclerosing cholangitis, alcoholic liver disease, or nonalcoholic steatohepatitis (NASH).
• Concurrent, serious, uncontrolled infection or known infection with human immunodeficiency virus (HIV) (HIV antibody positive), or diagnosis of acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or previous allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or previous solid organ transplantation.

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (23)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Maoming People's Hospital

Maoming, Guangdong, 525000, China

Location

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, 515041, China

Location

Yue Bei People's Hospital

Shaoguan, Guangdong, 512026, China

Location

Zhongshan City People's Hospital

Zhongshan, Guangdong, 528403, China

Location

Guigang City People's Hospital

Guigang, Guangxi, 537199, China

Location

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, 530021, China

Location

People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

Location

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, 550000, China

Location

Hainan General Hospital

Haikou, Hainan, 570311, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

Location

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, 341001, China

Location

Ganzhou Cancer Hospital

Ganzhou, Jiangxi, 341005, China

Location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

Location

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

Location

Yibin Second People's Hospital

Yibin, Sichuan, 644000, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Recurrence; Nasopharyngeal Carcinoma

Interventions

Capecitabine; Docetaxel

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Ruihua Xu, Doctor

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The study consists of two stages. Part A of this study is a single arm IIa clinical study and Part B is a parallel IIb study.

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: November 19, 2021
• Study Start: April 6, 2023
• Primary Completion: December 30, 2024
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (23)