Clinical trial · Interventional
A Phase II Study to Evaluate GFH375 in Patients With KRAS G12D Mutant Metastatic Pancreatic Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Adjustment of Product Development Strategy
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
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 (1)
- measure
- Overall response rate (ORR)
- timeFrame
- 24 months
- description
- ORR assessed by Blinded Independent Central Review
Secondary outcomes (7)
- measure
- ORR
- timeFrame
- 24 months
- description
- ORR assessed by investigators
- measure
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. With histologically or cytologically confirmed metastatic pancreatic cancer harboring KRAS G12D mutation 4. Be able to provide tumor tissue samples that meet the requirements 5. Have at least one measurable lesion according to RECIST1.1 6. ECOG performance status of 0-1. 7. With a life expectancy of ≥12 weeks. 8. Adequate laboratory parameters during the screening period. Exclusion Criteria: 1. Active brain metastases. 2. Prior treatment with a KRAS G12D inhibitor or a pan-RAS/KRAS inhibitor. 3. With poorly controlled or severe cardiovascular disease. 4. Subjects with active hepatitis B or active hepatitis C. 5. Known allergy to the study drug or its components. 6. Pregnant or lactating women.
References
Publications (0)
Data not yet available