This is an open-label, multi-center, phase I study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of MRG007 (ARR-217) in patients with unresectable locally advanced or metastatic solid tumors.
Willing to sign the informed consent form and follow the requirements specified in the protocol.
Life expectancy ≥ 3 months.
Tumor specimen available for CDH17 testing, or agree to biopsy at baseline.
Patients with histologically and cytologically confirmed advanced or metastatic solid tumor who have failed or intolerant to standard therapy, or without alternative standard therapy.
Patients with more than one cancer.
Received CDH17-targeting anti-tumor therapy; received other investigational product, systemic corticosteroids or surgery for major organs within 4 weeks prior to the first dose; received anti-tumor therapy within 3 weeks or within 5 half-lives prior to the first dose, whichever is shorter; received radiotherapy within 2 weeks prior to the first dose; received strong CYP3A4 inducers or inhibitors within 2 weeks prior to the first dose or 5 half-lives, whichever is longer; investigational therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose.
≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment
Symptomatic Central nervous system and/or meninges metastasis.
Sequential
MRG007
DrugMRG007 will be administrated as specified in the protocol.
MRG007 and Bevacizumab
DrugMRG007 will be administered as specified in the protocol
Dose Limiting Toxicity (DLT) - Phase Ia
Serious Adverse Events (SAEs)
Adverse events that are fatal, life-threatening, or result in hospitalization or prolonged hospitalization, persistent or significant disability/incapacity/substantial disruption of the ability to lead a normal life, congenital anomaly/birth defect or major medical events or reactions
Treatment-Emergent Adverse Event (TEAE)
AEs that occur or worsen on or after the first dose of study treatment
Treatment-Related Adverse Event
Any reaction, side effect, or untoward event that occurs during the course of the clinical trial is considered related to the study drug.
Objective Response Rate (ORR) - Phase Ia
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1.
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.
Duration of Response (DOR)
The time interval between the date of the earliest qualifying response and the date of disease progression or death for any cause, whichever occurs earlier.
Progression Free Survival (PFS) as assessed by investigator
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
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ArriVent BioPharma, Inc.
Lead sponsor
Lepu Biopharma Co., Ltd.
Collaborator
