The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with recurrent metastatic nasopharyngeal carcinoma.
The study consists of two stages. Part A of this study is an open-label, single arm, multicenter Phase IIa clinical study in patients with inoperable, radiotherapy ineligible RM-NPC who have failed (or are intolerable) at least 1 prior line platinum-based systemic chemotherapy and PD-1 (L1) inhibitors. Part B is an open-label, randomized, multicenter Phase IIb study to compare the efficacy and safety of MRG003 versus capecitabine/docetaxel in patients with RM-NPC who have failed at least 2 prior lines of systemic chemotherapy and PD-1 (L1) inhibitors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
238
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Objective Response Rate (ORR) by Independent Review Committee (IRC)
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by Independent Review Committee (IRC) according to RECIST v1.1.
Time frame: Baseline to disease progression, intolerable drug-related toxicities, withdrawal of consent, or study discontinuation for any reasons (up to 24 months)
Objective Response Rate (ORR) by Investigator
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.
Time frame: Baseline to Baseline to disease progression, intolerable drug-related toxicities, withdrawal of consent, or study discontinuation for any reasons (up to 24 months)
Progression Free Survival (PFS)
PFS is defined as the duration from the start of treatment or randomization (part B) to the onset of tumor progression or death of any cause.
Time frame: Baseline to Baseline to disease progression, intolerable drug-related toxicities, withdrawal of consent, or study discontinuation for any reasons (up to 24 months)
Duration of Response (DoR)
DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.
Time frame: Baseline to Baseline to disease progression, intolerable drug-related toxicities, withdrawal of consent, or study discontinuation for any reasons (up to 24 months)
Disease Control Rate (DCR)
DCR is defined as the proportions of patients achieving CR, PR, and stable disease (SD) after treatment.
Time frame: Baseline to Baseline to disease progression, intolerable drug-related toxicities, withdrawal of consent, or study discontinuation for any reasons (up to 24 months)
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Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Maoming People's Hospital
Maoming, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Yue Bei People's Hospital
Shaoguan, Guangdong, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
Guigang City People's Hospital
Guigang, Guangxi, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
...and 13 more locations
Overall Survival (OS)
OS is defined as the duration from the start of treatment or randomization (part B) to death of any cause.
Time frame: Sign the informed consent form to Baseline to disease progression, intolerable drug-related toxicities, withdrawal of consent, or study discontinuation for any reasons (up to 24 months)
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.
Time frame: Baseline to 30 (for AE) and 45 (for SAE) days after the last dose of study treatment.
PK parameter for MRG003: (Cmax)
Maximum observed plasma concentration.
Time frame: Baseline to 30 days after the last dose of study treatment
PK parameter for MRG003: (AUClast)
Area under the curve up to the last validated measurable plasma concentration.
Time frame: Baseline to 30 days after the last dose of study treatment.
PK parameter for total antibody (TAb): Cmax
Maximum observed plasma concentration.
Time frame: Baseline to 30 days after the last dose of study treatment.
PK parameter for TAb: AUClast
Area under the curve up to the last validated measurable plasma concentration.
Time frame: Baseline to 30 days after the last dose of study treatment.
PK parameter for Monomethyl Auristatin E (MMAE): Cmax
Maximum observed plasma concentration.
Time frame: Baseline to 30 days after the last dose of study treatment.
PK parameter for MMAE: AUClast
Area under the curve up to the last validated measurable plasma concentration.
Time frame: Baseline to 30 days after the last dose of study treatment.
The proportion of patients with positive ADA immunogenicity results.
The incidence of patients with positive ADA immunogenicity results per each pre-specified time point.
Time frame: Baseline to 30 days after the last dose of study treatment.