The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in combination with HX008 in patients with EGFR-positive advanced or metastatic solid tumors.
This study consists of two parts: Phase I and Phase II. The objective of this study is to assess the safety and tolerability of MRG003 in combination with HX008 in patients with EGFR-positive advanced or metastatic solid tumors; and to explore the maximum tolerated dose (MTD) and to determine the recommended phase II dose (RP2D) of combination therapy; and to evaluate the preliminary efficacy, pharmacokinetics, and immunogenicity of combination therapy in the targeted study population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Administered intravenously
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
NOT_YET_RECRUITINGMaximum Tolerated Dose (MTD)
MTD is the highest dose with the proportion of DLT less than 1/3
Time frame: Within 21 days after the first dose of the last patient of the MTD group
Recommended Phase II Dose (RP2D)
The dose level of MRG003 recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study.
Time frame: Baseline to study completion (up to 12 months)
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 by investigator according to RECIST v1.1.
Time frame: Baseline to study completion (up to 12 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 study completion (up to 12 months)
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects achieving CR, PR, and SD after treatment.
Time frame: Baseline to study completion (up to 12 months)
Progression Free Survival (PFS)
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Time frame: Baseline to study completion (up to 12 months)
Overall Survival (OS)
OS is defined as the duration from the start of treatment to death of any cause.
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Time frame: Baseline to study completion (up to 12 months)
Immunogenicity (ADA)
The proportion of patients with positive ADA results.
Time frame: Baseline to 90 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.
Time frame: Baseline to 30 days after the last dose of study treatment
Serious Adverse Events (SAEs)
Adverse events that are difficult to deal with in clinical drug research
Time frame: Baseline to 90 days after the last dose of study treatment
PK parameters: concentration-time curve
Plot of drug concentration changing with time after drug administration
Time frame: Baseline to 90 days after the last dose.