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RECRUITING
NCT07607054
PHASE1

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.

View on ClinicalTrials.gov

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

BIOLOGICAL

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