At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 407 target
Drug / intervention
GFH375drug
Likely dose
Not stated in record
Key inclusion· 5
- ✓Age 18-75 years
- ✓Histologically or cytologically confirmed advanced or metastatic solid tumors with KRAS G12D mutation
- ✓At least one measurable lesion by RECIST 1.1 (phase Ia may have no measurable lesion)
- ✓Life expectancy of at least 12 weeks
Key exclusion· 7
- ✕Active brain metastases
- ✕Prior treatment with a KRAS G12D inhibitor
- ✕Palliative radiotherapy completed within 14 days before first dose
- ✕Poorly controlled or severe cardiovascular disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating GFH375 for KRAS G12D Mutations and Advanced Solid Tumors. Currently recruiting, targeting 407 participants across 20 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKRAS G12D Mutations, Advanced Solid Tumors
CountriesChina
Collaborators--
Timeline
Phase 2Recruiting
20252026202720282029
Enrollment StartJul 2024
First PostedJul 2024
TodayJul 2026
Primary CompletionJul 2028
Study CompletionDec 2028
First PostedJul 15, 2024
Enrollment StartJul 9, 2024
Primary CompletionJul 31, 2028
Study CompletionDec 31, 2028
TodayJul 1, 2026
Enrollment to primary: 4.1 yearsPosted 2.0 years agoPrimary completion in 2.1 years
Interventions
GFH375drug
GFH375 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.