A First-in-human Phase I Study to Evaluate EMB-15 in Patients With 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

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

Conditions2

Interventions1

Browse More Trials