Clinical trial NCT06976190: A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Recurrent or Metastatic Nasopharyngeal Carcinoma
Keywords: MRG003
Pucotenlimab
Nasopharyngeal Carcinoma
Lead sponsor: Shanghai Miracogen Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-16
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Progression Free Survival (PFS) as assessed by BIRC
timeFrame: Baseline to study completion (up to 33 months)
measure: Overall Survival (OS)
timeFrame: Baseline to study completion (up to 48 months)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Baseline to study completion (up to 48 months)
measure: Disease Control Rate (DCR)
timeFrame: Baseline to study completion (up to 48 months)
measure: Progression Free Survival (PFS) as assessed by investigator
timeFrame: Baseline to study completion (up to 33 months)
measure: Immunogenicity (ADA)
timeFrame: Baseline to 14 days after the last dose.
measure: Adverse Events (AEs)
timeFrame: Baseline to 30 days after the last dose of study treatment
measure: Serious Adverse Events (SAEs)
timeFrame: Baseline to 30 days after the last dose of study treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ruihua Xu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: