A Study of GFH018 in Patients With Advanced Solid Tumors

A Phase I Study With Single/Multiple Dose Administered to Explore the Safety/Tolerability and Pharmacokinetics of GFH018 in the Treatment of Patients With Advanced Solid Tumors

This is the first- in human study of GFH018 comprised of a dose escalation part and a dose expansion part in subjects with advanced solid tumors after single/multiple administration. The study is designed to explore the safety/tolerability, pharmacokinetics, and MTD of GFH018 and to define a RP2D of GFH018.

Inclusion Criteria:

• Eligible subjects must meet all the inclusion criteria listed below:

  1. Voluntarily participate in this clinical trial and are willing to sign informed consent forms.
  2. Male or female aged from 18-75 years old (inclusive).
  3. Diagnosed with histologically or cytologically confirmed advanced solid tumors.
  4. Evaluable lesions defined by RECIST v1.1.
  5. Eastern Cooperative Oncology Group performance status of 0 to 1.
  6. Subjects or their legal representatives are able to communicate well with Investigators and are willing to comply with the protocol and complete the study.

Exclusion Criteria:

• Eligible subjects should not meet any of the exclusion criteria listed below:

  1. With clinically significant cardiac diseases.
  2. With clinically significant digestive disorders.
  3. Other severe disease.
  4. Pregnant or lactating women.
  5. Other unfavorable situations for subjects to participate in the study judged by Investigators.