NCT07607054 A First-in-human Phase I Study to Evaluate EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors.
| NCT ID | NCT07607054 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai EpimAb Biotherapeutics Co., Ltd. |
| Condition | Locally Advanced or Metastatic Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-05-26 |
| Primary Completion | 2029-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2026-05-26 with a primary completion date of 2029-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07607054 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced or Metastatic Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07607054 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07607054 currently recruiting?
Yes, NCT07607054 is actively recruiting participants. Contact the research team at xyang@epimab.com for enrollment information.
Where is the NCT07607054 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07607054 clinical trial?
NCT07607054 is sponsored by Shanghai EpimAb Biotherapeutics Co., Ltd.. The trial plans to enroll 50 participants.