WithdrawnPhase 2
A Phase II Study to Evaluate GFH375 in Patients With KRAS G12D Mutant Metastatic Pancreatic Cancer
Key facts
- Who runs it
- Genfleet Therapeutics (Shanghai) Inc.
- Trial code
- Status
- Withdrawn
- Phase
- Phase 2
- Started
- Aug 2025
- Expected to end
- Aug 2028
- Type of study
- Interventional
- Treatments tested
- GFH375
- Record updated
- 17 November 2025
- Why it stopped
- Adjustment of Product Development Strategy
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form
- Male or female ≥ 18 years old and ≤75 years old
- With histologically or cytologically confirmed metastatic pancreatic cancer harboring KRAS G12D mutation
- Be able to provide tumor tissue samples that meet the requirements
- Have at least one measurable lesion according to RECIST1.1
- ECOG performance status of 0-1
- With a life expectancy of ≥12 weeks
- Adequate laboratory parameters during the screening period
Who cannot take part
- Prior treatment with a KRAS G12D inhibitor or a pan-RAS/KRAS inhibitor
- With poorly controlled or severe cardiovascular disease
- Subjects with active hepatitis B or active hepatitis C
- Known allergy to the study drug or its components
- Active brain metastases
- Pregnant or lactating women
About the trial
What the trial wants to find out
This is a multicenter, open-label, phase II study to explore the efficacy, safety/tolerability and pharmacokinetics (PK) of GFH375 in in Patients with Previously Treated KRAS G12D Mutant Metastatic Pancreatic Cancer.
The group in the trial
- GFH375Treatment being tested
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Single-Arm, Multicenter, Open-Label, Phase II Clinical Study to Evaluate the Efficacy, Safety/Tolerability, and Pharmacokinetic Characteristics of GFH375 Monotherapy in Patients With Previously Treated KRAS G12D Mutant Metastatic Pancreatic Cancer
- Record updated
- 17 November 2025