A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasop… (NCT05126719) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma
China238 participantsStarted 2023-04-06
Plain-language summary
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with recurrent metastatic nasopharyngeal carcinoma.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing to sign the ICF and follow the requirements specified in the protocol.
* Age: ≥18 years, ≤75 years
* Expected survival time\>3 months.
* Patients with histologically confirmed unresectable, radiation-ineligible recurrent metastatic nasopharyngeal carcinoma.
* Part A: Metastatic nasopharyngeal carcinoma that has failed or recurred or was intolerant to at least 1 prior line platinum-based systemic chemotherapy and PD-1/PD-L1 inhibitors
* Part B: have documented failure of at least 2 prior lines of PD-1 (L1) and therapysystemic chemotherapy, which include at least platinum-based regimen, gemcitabine, taxanes/capecitabine.
* Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
* ECOG performance score 0 or 1.
* Organ functions and coagulation function must meet the basic requirements.
* No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%.
* Serum or urine pregnancy test negative within 72 hours before the first dose of investigational drug.
* Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.
Exclusion Criteria:
* Grade ≥2 peripheral neuropathy per CTCAE v5.0.
* Is expected to require surgery or any other form of systemic or local anti-tumor therapy during the study.
* Received systemic chemotherapy, targeted therapy, biologics or immunotherapy, or major surgery (exc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR) by Independent Review Committee (IRC)
Timeframe: Baseline to disease progression, intolerable drug-related toxicities, withdrawal of consent, or study discontinuation for any reasons (up to 24 months)