Metastatic Pancreatic Cancer
Conditions
Brief summary
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
DRUGGFH375
The experimental group receives GFH375 monotherapy, QD, orally
DRUGChemotherapy
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.
Sponsors
Genfleet Therapeutics (Shanghai) Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Experimental group: GFH375; Control group: investigator's choice of Chemotherapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OS | Up to approximately 2 years | Overall Survival |
| PFS | Up to approximately 2 years | Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by BICR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | Up to approximately 2 years | Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by investagors |
| ORR | Up to approximately 2 years | ORR assessed by investigators and BICR |
| DCR | Up to approximately 2 years | DCRassessed by investigators and BICR |
| DoR | Up to approximately 2 years | DoR assessed by investigators and BICR |
| TTR | Up to approximately 2 years | TTR assessed by investigators and BICR |
| The incidence and severity of AEs and SAEs | Up to approximately 2 years | The incidence and severity of AEs and SAEs |
| EORTC QLQ-C30 Score | Up to approximately 2 years | Changes in EORTC QLQ-C30 |
| EORTC QLQ-PAN26 Score | Up to approximately 2 years | Changes in EORTC QLQ-PAN26 Scores |
| Plasma concentrations of GFH375 | Up to approximately 2 years | Plasma concentrations of GFH375 |
Countries
China
Contacts
CONTACTJin Li
Outcome results
None listed