Recruiting
Phase 3
A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Condition(s) studied
Recurrent or Metastatic Nasopharyngeal Carcinoma
Investigational drug(s) / intervention(s)
MRG003 + Pucotenlimab: MRG003 will be administrated as specified in the protocol. Pucotenlimab will be administrated as specified in the protocol.
Gemcitabine, 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).
Study 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
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 outcome measure(s)
- Progression Free Survival (PFS) as assessed by BIRC — 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.
- Overall Survival (OS) — Baseline to study completion (up to 48 months)
OS is defined as the duration from the start of treatment to death of any cause.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Sun Yat-sen University Cancer Center |
Guangzhou |
Guangdong |
Recruiting |
More Lepu Biopharma Co., Ltd. trials in China
Other trials for the same condition
