Phase I Study Evaluating Safety and Effectiveness of MRG007 With or Without Bevacizumab in Patients With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating MRG007 ARR-217 in an open-label, multi-center phase I trial involving patients with unresectable locally advanced or metastatic solid tumors. The study aims to assess the safety, tolerability, efficacy, and pharmacokinetics of MRG007 in this patient population, including those with colorectal, gastric, or pancreatic cancers who have failed or are intolerant to standard therapies. This research is sponsored by ArriVent BioPharma, Inc. and involves dose escalation, confirmation, and expansion phases. Participants receive MRG007 alone or in combination with Bevacizumab according to the study protocol. The trial uses a sequential study model without randomization or masking. Treatment administration follows specific dosing schedules outlined in the protocol, with evaluations of dose-limiting toxicities and adverse events conducted from baseline through 30 days post-treatment. Objective response rates and other efficacy measures are monitored up to 24 months after starting treatment. Throughout the study, participants undergo evaluations including tumor assessments by RECIST criteria, performance status scoring, and laboratory tests to monitor organ and coagulation functions. Safety is closely tracked via serious and treatment-related adverse events. Pharmacokinetic parameters such as Tmax, Cmax, and antibody responses are also measured. Participants may be followed for up to two years to assess treatment response, disease control, progression-free survival, and overall survival.

A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors