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NCT Number: NCT06976190

A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

This is a randomized, open-label, multi-center, phase III study to evaluate the efficacy and safety, and immunogenicity of MRG003 in combination with pucotenlimab in patients with recurrent or metastatic nasopharyngeal carcinoma.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Ruihua Xu, M.D.

CONTACT

[email protected]

86-18127912775

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to sign the informed consent form and follow the requirements specified in the protocol.
  • Life expectancy ≥ 12 weeks.
  • Patients with histologically and cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) who have failed at least one line of prior systemic therapy.
  • Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
  • The score of ECOG for performance status is 0 or 1.
  • No severe cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%.
  • Organ functions and coagulation function must meet the basic requirements.
  • 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 hypersensitivity to any component of the investigational product.
  • Received systemic chemotherapy, targeted therapy, biological therapy or immunotherapy for anti-tumor purpose, or major surgery within 3 weeks prior to the first dose of study treatment.
  • Received anti-infection therapy within 2 weeks prior to the randomization
  • Prior treatment with MMAE/MMAF ADC drugs
  • Central nervous system metastasis.
  • Poorly controlled systemic diseases
  • Patients with poorly controlled heart diseases
  • Poorly controlled pleural and peritoneal effusion or pericardial effusion
  • ≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment
  • Patients with prior ≥Grade 3 immuno-related adverse events (irAEs)
  • Any clinically significant arteriovenous bleeding, pulmonary embolism, or deep venous thrombosis occurred within 3 months
  • Received allogeneic tissue/solid organ transplantation.
  • Inoculate live vaccine within 30 days before the first dose.
  • Patients with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 180 days after the last dose of study treatment.
  • History of other primary malignant tumor diseases.
  • Other situations that are not suitable to participate a clinical trial per investigator's judgement

Treatment and study plan

MRG003 + Pucotenlimab

Drug

MRG003 will be administrated as specified in the protocol. Pucotenlimab will be administrated as specified in the protocol.

Gemcitabine, Docetaxel, or Capecitabine

Drug

Gemcitabine will be administrated via intravenous infusion at 1000 mg/m2 once on Day 1 and 8 of every 3 weeks (21-day cycle).

Docetaxel will be administrated via intravenous infusion at 75 mg/m2 once on Day 1 of every 3 weeks (21-day cycle).

Capecitabine will be administrated orally at 1000 mg/m2 twice a day for Day 1 to 14 of every 3 weeks (21-day cycle).

Primary outcomes

  1. Progression Free Survival (PFS) as assessed by BIRC

    Time frame: Baseline to study completion (up to 33 months)

    PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

  2. Overall Survival (OS)

    Time frame: Baseline to study completion (up to 48 months)

    OS is defined as the duration from the start of treatment to death of any cause.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Baseline to study completion (up to 48 months)

    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.

  2. Disease Control Rate (DCR)

    Time frame: Baseline to study completion (up to 48 months)

    DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.

  3. Progression Free Survival (PFS) as assessed by investigator

    Time frame: Baseline to study completion (up to 33 months)

    PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

  4. Immunogenicity (ADA)

    Time frame: Baseline to 14 days after the last dose.

    The proportion of patients with positive ADA results.

  5. Adverse Events (AEs)

    Time frame: Baseline to 30 days after the last dose of study treatment

    Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.

  6. Serious Adverse Events (SAEs)

    Time frame: Baseline to 30 days after the last dose of study treatment

    Adverse events that are fatal, life-threatening, or result in hospitalization or prolonged hospitalization, persistent or significant disability/incapacity/substantial disruption of the ability to lead a normal life, congenital anomaly/birth defect or major medical events or reactions.

Study contacts

Contact information is provided by the study sponsor or research team.

Program Director

CONTACT

[email protected]

86-21-61637960

Sponsors and collaborators

Lead sponsor

Shanghai Miracogen Inc.

Industry

Registry information

Official study title

A Randomized, Open-label, Multi-center, Phase III Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Acronym: Magic-C002

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
May 16, 2025
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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