Recurrent or Metastatic Nasopharyngeal CarcinomaPhase 3Magic-C002NCT06976190
A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
A Phase 3 study testing MRG003 + Pucotenlimab and Gemcitabine, Docetaxel, or Capecitabine in people with Recurrent or Metastatic Nasopharyngeal Carcinoma, run by Lepu Biopharma Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent or Metastatic Nasopharyngeal Carcinoma
- What is being tested?
- MRG003 + Pucotenlimab and Gemcitabine, Docetaxel, or Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2025to Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ruihua Xu, M.D., 86-18127912775, xurh@sysucc.org.cn
About this study
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
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.
- Being tested
- MRG003 + Pucotenlimab, Gemcitabine, Docetaxel, or Capecitabine
- Keywords
- MRG003, Pucotenlimab, Nasopharyngeal Carcinoma
- Medical subject headings
- Recurrence, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG003 + PucotenlimabDrug
MRG003 will be administrated as specified in the protocol. Pucotenlimab will be administrated as specified in the protocol.
Gemcitabine, Docetaxel, or CapecitabineDrug
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 group | Role | What they receive |
|---|---|---|
| MRG003 + Pucotenlimab | Experimental | Not described Receives: Drug: MRG003 + Pucotenlimab |
| Chemotherapy Arm | Active comparator | Mono-chemotherapy as selected by investigator Receives: Drug: Gemcitabine, Docetaxel, or Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) as assessed by BIRC
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Measured: Baseline to study completion (up to 33 months)
Overall Survival (OS)
OS is defined as the duration from the start of treatment to death of any cause.
Measured: Baseline to study completion (up to 48 months)
Secondary outcomes (6)
Objective Response Rate (ORR)
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.
Measured: Baseline to study completion (up to 48 months)
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.
Measured: Baseline to study completion (up to 48 months)
Progression Free Survival (PFS) as assessed by investigator
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Measured: Baseline to study completion (up to 33 months)
Immunogenicity (ADA)
The proportion of patients with positive ADA results.
Measured: Baseline to 14 days after the last dose.
Adverse Events (AEs)
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.
Measured: Baseline to 30 days after the last dose of study treatment
Serious Adverse Events (SAEs)
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.
Measured: Baseline to 30 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start6 May 2025
- Primary completionMay 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Lepu Biopharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 446 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lepu Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruihua Xu, M.D., Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976190
- Sponsor's protocol ID
- HX008/MRG003-C002
- Acronym
- Magic-C002
- Status last verified
- Aug 2026
- First submitted
- 8 May 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06976190
- Acronym / sponsor ID
- Magic-C002 / HX008/MRG003-C002
- Keywords
- MRG003, Pucotenlimab, Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 446 participants (estimated)
- Lead sponsor
- Lepu Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 May 2025 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRG003 + Pucotenlimab | Experimental | Drug: MRG003 + Pucotenlimab |
| Chemotherapy Arm | Active comparator | Drug: Gemcitabine, Docetaxel, or CapecitabineMono-chemotherapy as selected by investigator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRG003 + PucotenlimabMRG003 will be administrated as specified in the protocol. Pucotenlimab will be administrated as specified in the protocol. | Drug | MRG003 + Pucotenlimab |
| Gemcitabine, Docetaxel, or CapecitabineGemcitabine 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). | Drug | Chemotherapy Arm |
Primary outcome
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.
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.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: Baseline to study completion (up to 48 months)
Disease Control Rate (DCR)
Time frame: Baseline to study completion (up to 48 months)
Progression Free Survival (PFS) as assessed by investigator
Time frame: Baseline to study completion (up to 33 months)
Immunogenicity (ADA)
Time frame: Baseline to 14 days after the last dose.
Adverse Events (AEs)
Time frame: Baseline to 30 days after the last dose of study treatment
Serious Adverse Events (SAEs)
Time frame: Baseline to 30 days after the last dose of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruihua Xu, M.D. principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MRG003 + Pucotenlimab and Gemcitabine, Docetaxel, or Capecitabine in people with Recurrent or Metastatic Nasopharyngeal Carcinoma, run by Lepu Biopharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Program Director (86-21-61637960, clinicaltrials@miracogen.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) as assessed by BIRC (time frame: Baseline to study completion (up to 33 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.