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Brief Title: A Study of EMB-09 in Participants With Advanced or Metastatic Solid Tumors.
Official Title: A First-in-human, Phase I Trial of EMB-09, a Bispecific Antibody Targeting PD-L1 and OX-40 in Patients With Advanced or Metastatic Solid Tumors
Study ID: NCT05263180
Brief Summary: This study is to evaluate the safety and tolerability of EMB-09 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-09 will also be assessed.
Detailed Description: This is a phase I, multi-center, open label, multiple dose, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose for EMB-09 in patient with advanced or metastatic solid tumors. Pharmacokinetics,pharmacodynamics, immunogenicity and response will also be assessed.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Peninsula and South Eastern Haematology & Oncology Group, Frankston, , Australia
GenesisCareNorthShore, Leonards Hill, , Australia
Blacktown Hospital, Sydney, , Australia
FUSCC, Shanghai, , China