Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GFH375, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Metastatic Pancreatic Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open-Label, Randomized Controlled Phase III Study to Compare the Efficacy and Safety/Tolerability of GFH375 Monotherapy Versus Investigator's Choice of Chemotherapy in Patients With Previously Treated KRAS G12D-Mutant Metastatic Pancreatic Cancer
Overview
This study plans to enroll participants with previously treated metastatic pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. These participants are required to experience disease progression on or after at least one prior standard systemic therapy containing fluorouracil or gemcitabine, and either progressed on or were intolerant to the last treatment. Eligible participants will be randomized 1:1 to the experimental group or the control group for treatment.
Interventions
- Drug GFH375
The experimental group receives GFH375 monotherapy, QD, orally - Drug Chemotherapy
The control group includes three treatment regimens: AG, nal-IRI + 5-FU/LV, and S-1. If participants are randomized to the control group, they will receive the treatment which is determined by the investigator.
Primary outcome measures
- OS [Time frame: Up to approximately 2 years]
- PFS [Time frame: Up to approximately 2 years]
Secondary outcome measures (9)
- PFS [Time frame: Up to approximately 2 years]
- ORR [Time frame: Up to approximately 2 years]
- DCR [Time frame: Up to approximately 2 years]
- DoR [Time frame: Up to approximately 2 years]
- TTR [Time frame: Up to approximately 2 years]
- The incidence and severity of AEs and SAEs [Time frame: Up to approximately 2 years]
- EORTC QLQ-C30 Score [Time frame: Up to approximately 2 years]
- EORTC QLQ-PAN26 Score [Time frame: Up to approximately 2 years]
- Plasma concentrations of GFH375 [Time frame: Up to approximately 2 years]
Eligibility criteria
Inclusion criteria
- Voluntarily participate in the study and sign the informed consent form.
- Male or female aged 18-80 years (inclusive) at the time of signing the informed consent form.
- Pathologically confirmed pancreatic cancer (derived from pancreatic ductal epithelium) at metastatic stage.
- Have received at least one prior standard systemic therapy.
- Participants must have at least one measurable lesion (per RECIST 1.1 criteria).
- Expected survival time ≥ 12 weeks as judged by the investigator.
- Have adequate organ function
Exclusion criteria
- Other malignant tumors that progressed or required treatment within 3 years prior to randomization.
- With active central nervous system (CNS) metastasis.
- Previous receipt of therapy targeted for KRAS G12D or pan-RAS/KRAS.
- Received radiotherapy within 4 weeks prior to randomization or other local anti-tumor therapy within 4 weeks prior to randomization.
- Received other anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to randomization.
- With clinically significant severe cardiovascular diseases.
- Stroke or other severe cerebrovascular diseases within 6 months prior to randomization.
- Complicated with major acute or chronic infectious diseases.
- Have severe mental or psychological diseases, or a history of drug abuse or severe alcoholism.
- Pregnant or lactating females.
- Other conditions deemed inappropriate for participation in the study by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Cancer Hospital & Institute — Beijing
Identifiers
NCT: NCT07262567 · GFH375X1301