First-in-human test of EMB-15 in adults with advanced or metastatic solid tumors
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
Run by Shanghai EpimAb Biotherapeutics Co., Ltd. · NCT07607054 · Data updated 2026-11-12
This early phase trial tests EMB-15 to see if it is safe and tolerable in adults whose solid tumors have progressed after standard care or have no standard therapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Shanghai EpimAb Biotherapeutics Co., Ltd. Industry-sponsored |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | May 26, 2026 |
| Main results expected | May 31, 2029 |
| Study ends | October 30, 2029 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT07607054 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with histologically or cytologically confirmed locally advanced or metastatic solid tumors lacking standard therapy or who progressed after standard care.
✕Probably not a fit
Patients whose tumors do not respond to EMB-15 or cannot tolerate its safety profile may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a first-in-human, open-label, multicenter Phase 1 study designed to find the recommended Phase 2 dose of EMB-15 and to characterize its safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity in adults with locally advanced or metastatic solid tumors. The study uses a dose-escalation approach followed by a dose-expansion phase and plans to enroll about 50 participants. Key periods include screening, a potential step-up dose period for higher-risk regimens, a 28-day treatment cycle (up to 2 years), and a post-treatment safety follow-up. Eligibility requires adults 18+ with adequate organ function and available tumor samples; major exclusions include prior ALPP/ALPG-targeting therapy, recent anticancer treatment, active autoimmune disease, and uncontrolled cardiovascular conditions.
Why it matters
Potential benefit: If successful, EMB-15 could provide a new treatment option for patients with difficult-to-treat solid tumors.
How similar studies have gone: As this is a first-in-human study, prior data are limited, and outcomes will determine whether the approach shows early signs of activity and safety.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- 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. 6\) Patients must provide archived tumor samples collected within 1 year. 7) Adequate hematological and organ function. Exclusion Criteria: * Patients meeting any of the following criteria will not be enrolled: 1. Any prior ALPP/ALPG targeting therapy 2. Has received anticancer therapy, radiotherapy, or investigational drug within \< 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment; 3. Active autoimmune disease or history of autoimmune disease 4. Concurrent malignancy \< 5 years prior to study entry 5. active infection 6. Severe or uncontrolled cardiovascular disease requiring treatment 7. Other severe medical conditions
Where it's running
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Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Xi Yang
- Email: xyang@epimab.com
- Phone: 86-21-61951000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.