Clinical trial · Interventional
A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
An Open-Label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GFH375 in Patients With KRAS G12D Mutant Advanced Solid Tumors
NCT06500676CI-TRIAL-00097646recruitingPhase 1 / Phase 2ClinicalTrials.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 a multicenter, open-label, phase I/II study to explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GFH375 in patients with advanced solid tumors harboring a KRAS G12D mutation.
Conditions
Conditions (2)
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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| KRAS G12D Mutations | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GFH375 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GFH375
- interventionNames
- Drug: GFH375
Primary outcomes (4)
- measure
- Phase Ia:The incidence and severity of AEs and SAEs
- timeFrame
- 24 months
- description
- The incidence and severity of AEs and SAEs
- measure
- Phase Ia:The incidence of DLT events
- timeFrame
- 21 days
- description
- The incidence of DLT events
- measure
- Phase Ib:The incidence and severity of AEs and SAEs
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. Male or female ≥ 18 years old and ≤75 years old. 3. ECOG performance status of 0-1. 4. With a life expectancy of ≥12 weeks. 5. With histologically or cytologically confirmed advanced or metastatic solid tumors harboring KRAS G12D mutation. 6. Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion. 7. Adequate laboratory parameters during the screening period. Exclusion Criteria: 1. Active brain metastases. 2. Prior treatment with a KRAS G12D inhibitor. 3. Palliative radiotherapy was completed within 14 days before the first dose. 4. Have poorly controlled or severe cardiovascular disease. 5. Subjects with active hepatitis B or active hepatitis C. 6. Known allergy to the study drug or its components. 7. Pregnant or lactating women.
References
Publications (0)
Data not yet available
No reference posted for this study.