Metastatic Pancreatic CancerPhase 3NCT07262567
Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer
A Phase 3 study testing GFH375 and Chemotherapy in people with Metastatic Pancreatic Cancer, run by Genfleet Therapeutics (Shanghai) Inc. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- GFH375 and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2025to Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142
Lin Shen
Lin Shen, Ph D
About this study
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
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.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- GFH375, Chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFH375Drug
The experimental group receives GFH375 monotherapy, QD, orally
ChemotherapyDrug
Also called Irinotecan Hydrochloride Liposome Injection, Fluorouracil Injection, Calcium Folinate, Tegafur,Gimeracil and Oteracil Potassium Capsules
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.
| Study group | Role | What they receive |
|---|---|---|
| GFH375 | Experimental | GFH375, Oral tablets Receives: Drug: GFH375 |
| Chemotherapy | Active comparator | There are three chemotherapy regimens. If participants are randomized to the control group, they will receive the treatment as determined by the investigator. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall Survival
Measured: Up to approximately 2 years
PFS
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by BICR
Measured: Up to approximately 2 years
Secondary outcomes (9)
PFS
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by investagors
Measured: Up to approximately 2 years
ORR
ORR assessed by investigators and BICR
Measured: Up to approximately 2 years
DCR
DCRassessed by investigators and BICR
Measured: Up to approximately 2 years
DoR
DoR assessed by investigators and BICR
Measured: Up to approximately 2 years
TTR
TTR assessed by investigators and BICR
Measured: Up to approximately 2 years
The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
Measured: Up to approximately 2 years
EORTC QLQ-C30 Score
Changes in EORTC QLQ-C30
Measured: Up to approximately 2 years
EORTC QLQ-PAN26 Score
Changes in EORTC QLQ-PAN26 Scores
Measured: Up to approximately 2 years
Plasma concentrations of GFH375
Plasma concentrations of GFH375
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start4 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Genfleet Therapeutics (Shanghai) Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: GFH375; Control group: investigator's choice of Chemotherapy
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262567
- Sponsor's protocol ID
- GFH375X1301
- Status last verified
- Jun 2026
- First submitted
- 20 Nov 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07262567
- Acronym / sponsor ID
- GFH375X1301
- Conditions
- Metastatic Pancreatic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental group: GFH375; Control group: investigator's choice of Chemotherapy
| Arm | Type | Receives |
|---|---|---|
| GFH375 | Experimental | Drug: GFH375GFH375, Oral tablets |
| Chemotherapy | Active comparator | Drug: ChemotherapyThere are three chemotherapy regimens. If participants are randomized to the control group, they will receive the treatment as determined by the investigator. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GFH375The experimental group receives GFH375 monotherapy, QD, orally | Drug | GFH375 |
| ChemotherapyAlso: Irinotecan Hydrochloride Liposome Injection, Fluorouracil Injection, Calcium Folinate, Tegafur,Gimeracil and Oteracil Potassium CapsulesThe 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. | Drug | Chemotherapy |
Primary outcome
OS
Time frame: Up to approximately 2 years
Overall Survival
PFS
Time frame: Up to approximately 2 years
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by BICR
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GFH375 and Chemotherapy in people with Metastatic Pancreatic Cancer, run by Genfleet Therapeutics (Shanghai) Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin Li (+86 21 6882 1388, jli@genfleet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.