Clinical trial · Interventional
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
NCT05051241CI-TRIAL-00074574completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GFH018 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (10)
- type
- EXPERIMENTAL
- label
- Dose escalation Cohort 1
- description
- 5 mg BID, 14d-on/14d-off
- interventionNames
- Drug: GFH018
- type
- EXPERIMENTAL
- label
- Dose escalation Cohort 2
- description
- 10 mg BID, 14d-on/14d-off
- interventionNames
- Drug: GFH018
- type
- EXPERIMENTAL
- label
- Dose escalation Cohort 3
- description
- 20 mg BID, 14d-on/14d-off
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGuo Y, Wang Z, Zhou H, Pan H, Han W, Deng Y, Li Q, Xue J, Ge X, Wang S, Wang J, Zhang Y, Zhao C, Zhu H, Wang Y, Shen H, Liu D, Li J. First-in-human study of GFH018, a small molecule inhibitor of transforming growth factor-beta receptor I inhibitor, in patients with advanced solid tumors. BMC Cancer. 2024 Apr 10;24(1):444. doi: 10.1186/s12885-024-12216-7. PMID 38600507