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 potent CYP3A4 inducers or inhibitors within 2 weeks prior to the first dose or 5 half-lives of investigational product, whichever is longer.
≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment
Symptomatic Central nervous system and/or meninges metastasis.
ArriVent BioPharma, Inc.
Lead sponsor
Lepu Biopharma Co., Ltd.
Collaborator