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RecruitingNCT07262567Updated Aug 14, 2026

Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer

A Phase 3 interventional study of GFH375 and Chemotherapy in Metastatic Pancreatic Cancer, sponsored by Genfleet Therapeutics (Shanghai) Inc.. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Genfleet Therapeutics (Shanghai) Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Metastatic Pancreatic Cancer
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
320 participants (estimated)

Study arms

  • Experimental
    GFH375

    GFH375, Oral tablets

    Drug: GFH375

  • Active comparator
    Chemotherapy

    There are three chemotherapy regimens. If participants are randomized to the control group, they will receive the treatment as determined by the investigator.

    Drug: Chemotherapy

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.

    Also known as: Irinotecan Hydrochloride Liposome Injection, Fluorouracil Injection, Calcium Folinate, Tegafur,Gimeracil and Oteracil Potassium Capsules, Gemcitabine Hydrochloride for Injection, Paclitaxel for Injection(Albumin Bound)

05

What researchers measure

Primary outcomes

  1. OS

    Overall Survival

    Time frame: Up to approximately 2 years

  2. PFS

    Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by BICR

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. PFS

    Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by investagors

    Time frame: Up to approximately 2 years

  2. ORR

    ORR assessed by investigators and BICR

    Time frame: Up to approximately 2 years

  3. DCR

    DCRassessed by investigators and BICR

    Time frame: Up to approximately 2 years

  4. DoR

    DoR assessed by investigators and BICR

    Time frame: Up to approximately 2 years

  5. TTR

    TTR assessed by investigators and BICR

    Time frame: Up to approximately 2 years

  6. The incidence and severity of AEs and SAEs

    The incidence and severity of AEs and SAEs

    Time frame: Up to approximately 2 years

  7. EORTC QLQ-C30 Score

    Changes in EORTC QLQ-C30

    Time frame: Up to approximately 2 years

  8. EORTC QLQ-PAN26 Score

    Changes in EORTC QLQ-PAN26 Scores

    Time frame: Up to approximately 2 years

  9. Plasma concentrations of GFH375

    Plasma concentrations of GFH375

    Time frame: Up to approximately 2 years

06

Study locations

1 of 1 sites recruiting
  • Peking University Cancer Hospital & Institute
    Beijing, Beijing Municipality 100142, China
    • Lin Shen · Contact
    • Lin Shen, Ph D · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07262567
Lead sponsor
Genfleet Therapeutics (Shanghai) Inc.
Responsible party
Sponsor
First posted
Dec 3, 2025
Start date
Dec 4, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Aug 14, 2026

Study contacts

Jin Li
Contact
jli@genfleet.com
+86 21 6882 1388

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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