The objective of this study is to assess the safety and tolerability of MRG002 in combination with HX008 in patients with HER2-expressed advanced malignant 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
30
Administrated intravenously
Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGShandong Cancer Hospital
Jinan, Shandong, China
Incidence of dose limiting toxicity (DLT) in each dose group
DLT is defined as any of the treatment emergent adverse events (TEAE) as specified in the protocol that bear a definite, probable, or possible causal relationship to study drug administration within 28 days after the first dose.
Time frame: Within 28 days after the first dose.
Adverse events
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: After signing informed consent until 90 days after the last dose.
Recommended Phase II Dose (RP2D)
The dose level of MRG002 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 24 months)
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with CR and PR according to RECIST v1.1.
Time frame: Baseline to study completion (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 study completion (up to 24 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 24 months)
Progression Free Survival (PFS)
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Shanghai Oriental Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGPFS 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 24 months)
Time to Response (TTR)
TTR is defined as the time from the start of treatment until the first occurrence of CR or PR by tumor assessment.
Time frame: Baseline to study completion (up to 24 months)
Overall Survival (OS)
OS is defined as the duration from the start of treatment to death of any cause.
Time frame: Baseline to study completion (up to 24 months)
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.
Immunogenicity (ADA)
The proportion of patients with positive ADA results.
Time frame: Baseline to 90 days after the last dose.