A First-in-human Phase I Study to Evaluate EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors.
Recruiting
Phase 1
Interventional Study
Locally Advanced or Metastatic Solid Tumors
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd. · Industry
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About This Trial
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.
Trial Locations
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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 …
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