RecruitingPhase 3NCT06976190

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

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


Sponsor

Shanghai Miracogen Inc.

Enrollment

446 participants

Start Date

May 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a combination of MRG003 (an antibody-drug conjugate that delivers chemotherapy directly to EGFR-expressing cancer cells) plus pucotenlimab (an immune checkpoint drug) against standard chemotherapy in people with nasopharyngeal carcinoma (NPC) — a type of head and neck cancer — that has come back or spread. **You may be eligible if...** - You have confirmed recurrent or metastatic nasopharyngeal carcinoma - Your cancer has progressed after at least one prior treatment - You have at least one measurable tumor - Your physical performance score is ECOG 0 or 1 - Your heart pumping function (LVEF) is 50% or higher **You may NOT be eligible if...** - You have uncontrolled brain metastases - You have serious heart, liver, kidney, or coagulation problems - You have had severe allergic reactions to similar drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMRG003 + Pucotenlimab

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

DRUGGemcitabine, Docetaxel, or Capecitabine

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).


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06976190


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