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.
Willing to sign the informed consent form and follow the requirements specified in the protocol.
Aged 18 to 75 (including 18 and 75), both genders.
BMI ≥17
Life expectancy ≥ 12 weeks.
History of hypersensitivity to any component of the investigational product.
Prior treatment with chemotherapy, biological therapy, immunotherapy, radiotherapy, investigational drugs, attenuated live vaccines, immunomodulators, CYP3A4 inhibitors/inducers, antibody-drug conjugates, Received major surgery without complete recovery, etc.
Treatment with MMAE/MMAF ADC drugs
Central nervous system metastasis.
Single group
MRG003+HX008
DrugAdministered intravenously
Maximum Tolerated Dose (MTD)
MTD is the highest dose with the proportion of DLT less than 1/3
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.
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.
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.
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects achieving CR, PR, and SD after treatment.
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.
Overall Survival (OS)
OS is defined as the duration from the start of treatment to death of any cause.
Click on the lead sponsor to view all of their trials.
