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New pill takes on tough pancreatic cancer in major trial

NCT ID NCT07262567

Disease control Sponsor: Genfleet Therapeutics (Shanghai) Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study tests a new daily pill, GFH375, against standard chemotherapy in 320 people with advanced pancreatic cancer that has a specific KRAS G12D gene mutation. Participants must have already tried at least one standard treatment. The goal is to see if the new drug helps people live longer or keeps the cancer from growing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GFH375
What this could lead to
If successful, this could provide a new targeted treatment option for people with a specific genetic form of pancreatic cancer that has stopped responding to standard chemotherapy.
What could go wrong
This is an early-stage Phase 3 trial, so results are not guaranteed. The drug may not improve survival or could have side effects. It only applies to patients with the KRAS G12D mutation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

exocrine pancreatic carcinoma malignant pancreatic neoplasm pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic pancreatic cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking University Cancer Hospital & Institute

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

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