MRG003 plus pucotenlimab versus chemotherapy for recurrent or metastatic nasopharyngeal carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label, phase III study enrolls patients with recurrent or metastatic nasopharyngeal carcinoma who have failed at least one prior systemic therapy and have measurable disease. Participants are assigned to receive either MRG003 plus the PD‑1 inhibitor pucotenlimab or investigator-choice chemotherapy (gemcitabine, docetaxel, or capecitabine). The trial will compare tumor response, safety, and immunogenicity using RECIST v1.1 criteria and standard toxicity assessments in patients with ECOG performance status 0–1. Key entry requirements include adequate organ and cardiac function, life expectancy of at least 12 weeks, and effective contraception for those with childbearing potential.

Why it matters

Who can join: the full rules

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

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Ruihua Xu, M.D. — Sun Yat-Sen University Cancer Center
• Study coordinator: Program Director
• Email: clinicaltrials@miracogen.com.cn
• Phone: 86-21-61637960

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pucotenlimab and Anlotinib with Chemo Before Surgery for Early-Stage Triple-Negative Breast Cancer

  This study tests a combo of pucotenlimab, anlotinib, and nab-paclitaxel before surgery in adults with newly diagnosed, stage II-III triple-negative breast cancer that is PD-L1 known.

  Recruiting Phase 2 Zhejiang Cancer Hospital · Hangzhou · NCT07896668

• Becotatug Vedotin plus Pucotenlimab for EGFR-positive metastatic colorectal cancer

  This study tests whether combining becotatug vedotin with pucotenlimab can shrink tumors in adults with colorectal cancer that has returned or spread after at least two prior treatments and whose tumors express EGFR.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT07884188

• Triple-drug neoadjuvant therapy for EGFR-positive locally advanced head and neck cancer

  This trial tests a three-drug neoadjuvant regimen (Becotatug Vedotin, Pucotenlimab, and Cisplatin) in adults with EGFR-positive, locally advanced head and neck cancer to see if it can shrink tumors before surgery or chemoradiotherapy.

  Recruiting at 2 sites Phase 2 Sun Yat-sen University · Guangzhou, Guangdong and 1 other locations · NCT07814287

• Combo of tunlametinib, pucotenlimab, and hydroxychloroquine in NRAS-mutant melanoma

  This study tests whether adding hydroxychloroquine to tunlametinib and pucotenlimab helps people with NRAS-mutant melanoma.

  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong · NCT07750067

• Becotatug Vedotin Plus Pucotenlimab in EGFR-High Advanced Cancers

  This phase II study tests whether combining Becotatug Vedotin with Pucotenlimab helps people whose advanced solid tumors express high EGFR.

  Recruiting Phase 2 Tianjin Medical University Second Hospital · Tianjin, Tianjin Municipality · NCT07712029

• Neoadjuvant EGFR-ADC plus anti-PD-1 therapy for resectable locally advanced hypopharyngeal cancer

  This trial tests whether a targeted EGFR-ADC drug plus an anti-PD-1 antibody given before surgery can improve outcomes for adults with resectable locally advanced hypopharyngeal squamous cell carcinoma.

  Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07665190

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.