This is a phase I open label, single-arm, dose-escalation study to evaluate the feasibility, safety, tolerability, PK/PD, and to determine RP2D of MT027 via an locoregional delivery in subjects with pleural malignant tumors, who have previously received standard of care therapy..
Subjects meeting the study entry criteria including having tumor antigen B7H3 overexpression via immunohistochemistry (IHC ) will be enrolled and assigned to cohorts sequentially to receive study treatments, assessments, as well as post-treatment safety follow-ups in the study.
voluntarily participate in the study and sign informed consent;
age over 18 years old (including the cut-off value), regardless of gender;
advanced malignant solid tumor pathologically and/or histologically diagnosed with malignant pleural effusion requiring drainage confirmed by histopathology or cytopathology (metastatic or primary);
the original pleural cavity malignant tumor after standard treatment failure, or top treatment;
known allergy to the study drug or its excipients;
patients with pleural puncture contraindications or won't benefit from intrathoracic medication;
any antineoplastic drugs other than systemic antineoplastic therapy that the subject has been taking stably and any treatment that may have an effect on the control of pleural effusion (other than diagnostic puncture or thoracentesis for investigational treatment);
in the first test within 2 weeks before treatment received radiotherapy.
Suzhou Maximum Bio-tech Co., Ltd.
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator