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New hope for Hard-to-Treat cancers: targeted drug enters human trials

NCT ID NCT06500676

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests an experimental drug called GFH375 in people with advanced solid tumors that have a specific genetic change (KRAS G12D). The goal is to see if the drug is safe, tolerable, and can shrink tumors. About 407 adults aged 18 to 75 with advanced cancers like lung or pancreatic cancer will take part. The drug is taken by mouth and aims to block a key cancer growth signal.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 407 people

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

Started

Jul 2024

Expected to finish

Dec 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 75 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: 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. Male or female ≥ 18 years old and ≤75 years old. 3. ECOG performance status of 0-1. 4. With a life expectancy of ≥12 weeks. 5. With histologically or cytologically confirmed advanced or metastatic solid tumors harboring KRAS G12D mutation. 6. Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion. 7. Adequate laboratory parameters during the screening period. Exclusion Criteria: 1. Active brain metastases. 2. Prior treatment with a KRAS G12D inhibitor. 3. Palliative radiotherapy was completed within 14 days before the first dose. 4. Have poorly controlled or severe cardiovascular disease. 5. Subjects with active hepatitis B or active hepatitis C. 6. Known allergy to the study drug or its components. 7. Pregnant or lactating women.

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As listed by the trial registrant

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

Advanced solid tumors KRAS G12D mutations

How to take part

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

  1. The places running it

    20 sites. 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

  • Cancer Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, China

  • Guangxi Medical University Cancer Hospital

    NOT_YET_RECRUITING

    Nanning, Guangxi, China

  • Harbin Medical University Cancer Hospital

    NOT_YET_RECRUITING

    Haerbin, Heilongjiang, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, China

  • Liaoning Cancer Hospital & Institute

    NOT_YET_RECRUITING

    Shenyang, Liaoning, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, China

  • Shanghai Chest Hospital

    RECRUITING

    Shanhai, Shanghai Municipality, 201210, China

  • Sichuan Cancer Hospital

    NOT_YET_RECRUITING

    Chengdu, Sichuan, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital Zhejiang University School of Medicine

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, China

  • The First Affiliated Hospital of Anhui Medical University

    NOT_YET_RECRUITING

    Hefei, Anhui, China

  • The First Affiliated Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • Tianjin Medical University Cancer Institute & Hospital

    NOT_YET_RECRUITING

    Tianjing, Tianjing, China

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, China

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