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 range18 Years – 75 Years
SexALL
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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…
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)