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A First-in-human Phase I Study to Evaluate EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors.
Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.
Summary
The primary purpose of this study is to evaluate safety and tolerability profile of EMB-15, identify the recommended Phase 2 dose(s) (RP2Ds) for EMB-15. Pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and the anti-tumor activity of EMB-15 will also be assessed.
Official title: A First-in-Human, Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Antitumor Activity of EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-05-26
Completion Date
2029-10-30
Last Updated
2026-06-15
Healthy Volunteers
No
Interventions
EMB-15
EMB-15 is a recombinant humanized bi-specific antibody against ALPP/ALPG and CD3
Locations (1)
Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China