ClinicalTrials.gg
RecruitingNCT07784374Updated Oct 2, 2026

A Phase II Study of GFH375 Combined With GFS202A or GFH276 Versus GFH375 in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation

A Phase 2 interventional study of GFH375 and GFH276 in 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 2026-10-02.

Sponsored by Genfleet Therapeutics (Shanghai) Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 2, 2026Now RecruitingSite recruiting status changed+2 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 629 studies in Pancreatic Neoplasms with a site in China — 335 open to participants now, 359 under way, 30 of them phase 3. Pancreatic Neoplasms · China.

Planned enrollment
133rd of 507
120 · median 58
Started
2026
with 56 others
Phase 2
154 of 629
89 open now
Primary completion
2028-08
later than 310 of 358 live
Registered
610th of 629
by date

Among the 629 studies in Pancreatic Neoplasms with a site in China, this one is the 133rd largest by planned enrollment of the 507 interventional ones that give a count, is one of 57 that started in 2026, is one of 154 in phase 2, reaches primary completion later than 310 of the 358 other live ones, and was the 610th registered.

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.

Browse Pancreatic Neoplasms studies →

Open to participants now

335 of the 629 studies in Pancreatic Neoplasms with a site in China are open now. Recruiting first, the newest first:

329 more — sign in →

All 335 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 746 Pancreatic Neoplasms studies recruiting now, 479 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 629 studies in Pancreatic Neoplasms with a site in China, or all of them as a file.
02

Study summary

This is a phase 2 study. All subjects are patients with locally advanced unresectable or metastatic pancreatic cancer harboring KRAS G12D mutation who have received at least one prior line of systemic therapy. The purpose of this study is to evaluate the anti-tumor efficacy of GFH375 plus GFH276 versus GFH375 monotherapy, and to assess the impact of GFH375 plus GFS202A versus GFH375 monotherapy on patient body weight.

03

Conditions studied

  • Pancreatic Cancer
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Able to provide written prior to any study-related procedures.
  • Male or female subjects aged between 18 and 80 years (inclusive) at the time of informed consent.
  • or cytologically confirmed pancreatic adenocarcinoma.
  • Estimated ≥ 3 months as judged by the investigator.
  • Has received at least 1 prior line of systemic anti-tumor therapy.
  • Has at least one per version 1.1.
  • Adequate organ function.

Exclusion criteria

Exclusion Criteria:

  • Other that has progressed or required treatment within 3 years prior to study entry.
  • Active central nervous system (CNS) .
  • Prior treatment with KRAS G12D-specific or pan-RAS/KRAS targeted agents.
  • severe cardiovascular disease.
  • Stroke or other severe cerebrovascular events within 6 months prior to randomization.
  • Significant acute or chronic infectious disease.
  • Severe psychiatric disorder, history of drug abuse, or significant alcohol abuse.
  • Pregnant or lactating female subjects.
  • Other conditions that, in the investigator's opinion, make the subject unsuitable for study participation.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    GFH375+GFH276

    Drug: GFH375 · Drug: GFH276

  • Experimental
    GFH375+GFS202A

    Drug: GFH375 · Drug: GFS202A

  • Experimental
    GFH375

    Drug: GFH375

Interventions

  • DrugGFH375

    administered per protocol-specified schedule

  • DrugGFH276

    administered per protocol-specified schedule

  • DrugGFS202A

    administered per protocol-specified schedule

06

What researchers measure

Primary outcomes

  1. PFS

    Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1

    Time frame: Up to approximately 2 years

  2. Weight

    Percentage Change in Body Weight From Baseline at Week 12

    Time frame: Baseline, From first study treatment to Week 12

Secondary outcomes

  1. OS

    Overall Survival (OS)

    Time frame: Up to approximately 3 years

  2. PFS

    Progression-Free Survival (PFS) Assessed by Investigator per RECIST Version 1.1

    Time frame: Up to approximately 2 years

  3. ORR

    Objective Response Rate (ORR), Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1

    Time frame: Up to approximately 2 years

  4. DCR

    Disease Control Rate (DCR)Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1

    Time frame: Up to approximately 2 years

  5. DoR

    Duration of Response (DoR)Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1

    Time frame: Up to approximately 2 years

  6. TTR

    Time-to-Response (TTR) Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1

    Time frame: Up to approximately 2 years

  7. The incidence and severity of AEs and SAEs

    The incidence and severity of AEs and SAEs

    Time frame: Up to approximately 2 years

  8. Plasma concentration of GFH375

    Trough concentration of GFH375

    Time frame: Up to approximately 2 years

  9. Plasma concentration of GFH276

    Trough concentration of GFH276

    Time frame: Up to approximately 2 years

  10. Plasma concentration of GFS202A

    Trough concentration of GFS202A

    Time frame: Up to approximately 2 years

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Aug 2028, 24 months after the start.

Of 69 industry-sponsored phase 2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 68. This study's planned 24 months is below that.

Counting every sponsor, half of 393 studies reached it within 57 months; a quarter within 35 and three quarters within 80.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2026
First posted
Aug 25, 2026
StartActual
Aug 20, 2026
Primary completionEst.
Aug 31, 2028
CompletionEst.
Aug 31, 2029
Last update
Oct 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 2, 2026
Sites
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine is now Recruiting
Oct 2, 2026
Start date
Aug 31, 2026→Aug 20, 2026 (actual)
Oct 2, 2026
Secondary outcomes
3 removed
What changed in the outcomes
  • RemovedFAACT ScoresTime frame: Up to approximately 2 years
  • RemovedL3SMITime frame: Up to approximately 2 years
  • RemovedChange in third-lumbar-level fat areaTime frame: Up to approximately 2 years
Oct 2, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai, ChinaContact added s•••@shsum.edu.cn · •••0045
Oct 2, 2026
Title
A Phase II Study of GFH375 Combined With GFS202A or GFH276 Versus GFH375 Monotherapy in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Not yet recruiting→Recruiting
    Ruijin Hospital, Shanghai Jiao Tong University School of Medicine is now Recruiting
    Start date Aug 31, 2026→Aug 20, 2026 (now actual)
    Secondary outcomes 3 removed
    What changed in the outcomes
    • RemovedFAACT ScoresTime frame: Up to approximately 2 years
    • RemovedL3SMITime frame: Up to approximately 2 years
    • RemovedChange in third-lumbar-level fat areaTime frame: Up to approximately 2 years
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai, ChinaContact added s•••@shsum.edu.cn · •••0045
    Title A Phase II Study of GFH375 Combined With GFS202A or GFH276 Versus GFH375 Monotherapy in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07784374
Responsible party
Sponsor
First posted
Aug 25, 2026
Start date
Aug 20, 2026
Primary completion
Aug 31, 2028 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Oct 2, 2026

Study contacts

Lizhi Yi +86 21 6882 1388
Contact
lzyi@genfleet.com
+86 21 6882 1388

Oversight

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

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Studies of the drug tested here: KRAS G12D Inhibitor VS-7375

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