Phase 1
Completed N=47
A Study of GFH018 in Patients With Advanced Solid Tumors
Advanced Solid Tumor
Source: ClinicalTrials.gov NCT05051241 ↗
Enrolled (actual)
47
Serious AEs
20.0%
Results posted
Mar 2024
Primary outcomePrimary: Incidence of Dose-limiting Toxicity (DLT) Events — 0; 0; 0; 0 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Dose-limiting Toxicity (DLT) Events |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Eligible subjects must meet all the inclusion criteria listed below:
- Voluntarily participate in this clinical trial and are willing to sign informed consent forms.
- Male or female aged from 18-75 years old (inclusive).
- Diagnosed with histologically or cytologically confirmed advanced solid tumors.
- Evaluable lesions defined by RECIST v1.1.
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- 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:
- With clinically significant cardiac diseases.
- With clinically significant digestive disorders.
- Other severe disease.
- Pregnant or lactating women.
- Other unfavorable situations for subjects to participate in the study judged by Investigators.
Data sourced from ClinicalTrials.gov (NCT05051241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.