Metastatic Pancreatic CancerPhase 2NCT07026916
A Phase II Study to Evaluate GFH375 in Patients With KRAS G12D Mutant Metastatic Pancreatic Cancer
A Phase 2 study testing GFH375 in people with Metastatic Pancreatic Cancer, run by Genfleet Therapeutics (Shanghai) Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- GFH375
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Aug 2028
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
- Male or female ≥ 18 years old and ≤75 years old.
- With histologically or cytologically confirmed metastatic pancreatic cancer harboring KRAS G12D mutation
- Be able to provide tumor tissue samples that meet the requirements
- Have at least one measurable lesion according to RECIST1.1
- ECOG performance status of 0-1.
- With a life expectancy of ≥12 weeks.
- Adequate laboratory parameters during the screening period.
Who cannot join
- Active brain metastases.
- Prior treatment with a KRAS G12D inhibitor or a pan-RAS/KRAS inhibitor.
- With poorly controlled or severe cardiovascular disease.
- Subjects with active hepatitis B or active hepatitis C.
- Known allergy to the study drug or its components.
- Pregnant or lactating women.
About this study
Official title: 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
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
- Metastatic Pancreatic Cancer
- Being tested
- GFH375
- 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
GFH375 will be administered at the 600mg QD, orally, until disease progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| GFH375 | Experimental | Not described Receives: Drug: GFH375 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
ORR assessed by Blinded Independent Central Review
Measured: 24 months
Secondary outcomes (7)
ORR
ORR assessed by investigators
Measured: 24 months
DCR
Disease control rate (DCR)
Measured: 24 months
DoR
Duration of Response (DoR)
Measured: 24 months
TTR
Time to Response(TTR)
Measured: 24 months
PFS
Progression Free Survival (PFS)
Measured: 24 months
The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
Measured: 24 months
Plasma concentrations of GFH375
Plasma concentrations of GFH375
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Why it stopped: Adjustment of Product Development Strategy
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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
- NCT07026916
- Sponsor's protocol ID
- GFH375X1201
- Status last verified
- Nov 2025
- First submitted
- 3 Jun 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07026916
- Acronym / sponsor ID
- GFH375X1201
- Conditions
- Metastatic Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Adjustment of Product Development Strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 18 Jun 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GFH375 | Experimental | Drug: GFH375 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
- Male or female ≥ 18 years old and ≤75 years old.
- With histologically or cytologically confirmed metastatic pancreatic cancer harboring KRAS G12D mutation
- Be able to provide tumor tissue samples that meet the requirements
- Have at least one measurable lesion according to RECIST1.1
Key exclusion criteria (6 listed)
- Active brain metastases.
- Prior treatment with a KRAS G12D inhibitor or a pan-RAS/KRAS inhibitor.
- With poorly controlled or severe cardiovascular disease.
- Subjects with active hepatitis B or active hepatitis C.
- Known allergy to the study drug or its components.
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 |
|---|---|---|
| GFH375GFH375 will be administered at the 600mg QD, orally, until disease progression or intolerable toxicity. | Drug | GFH375 |
Primary outcome
Overall response rate (ORR)
Time frame: 24 months
ORR assessed by Blinded Independent Central Review
7 secondary outcomes
ORR
Time frame: 24 months
DCR
Time frame: 24 months
DoR
Time frame: 24 months
TTR
Time frame: 24 months
PFS
Time frame: 24 months
The incidence and severity of AEs and SAEs
Time frame: 24 months
Plasma concentrations of GFH375
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GFH375 in people with Metastatic Pancreatic Cancer, run by Genfleet Therapeutics (Shanghai) Inc..
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 8 inclusion and 6 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: withdrawn, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 24 months). 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 17 Nov 2025.