RecruitingPhase 1NCT07607054

A First-in-human Phase I Study to Evaluate EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors.

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

Sponsor

Shanghai EpimAb Biotherapeutics Co., Ltd.

Enrollment

50 participants

Start Date

May 26, 2026

Study Type

INTERVENTIONAL

Conditions

Locally Advanced or Metastatic Solid Tumors

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

\- 1) Able to understand and willing to sign an ICF 2) Males or females with the age ≥ 18 years 3) Life expectancy > 3 months. 4) ECOG performance status 0 or 1 5) Patients must have histologically or cytologically confirmed locally advanced or metastatic solid tumors, without standard therapy.
\) Patients must provide archived tumor samples collected within 1 year. 7) Adequate hematological and organ function.

Exclusion Criteria8

Patients meeting any of the following criteria will not be enrolled:
Any prior ALPP/ALPG targeting therapy
Has received anticancer therapy, radiotherapy, or investigational drug within < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
Active autoimmune disease or history of autoimmune disease
Concurrent malignancy < 5 years prior to study entry
active infection
Severe or uncontrolled cardiovascular disease requiring treatment
Other severe medical conditions