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

Recruiting now · Phase 1

Conditions studied: Locally Advanced or Metastatic Solid Tumors

In brief

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.

Key facts

Study ID

NCT07607054

Run by

Shanghai EpimAb Biotherapeutics Co., Ltd.

People needed

50

Starts

2026-05-26

Expected to finish

2029-10-30

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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