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New drug combo targets Hard-to-Treat cancers with RAS mutations

NCT ID NCT07678593

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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tests an experimental oral drug called GFH276 combined with either cetuximab or standard chemotherapy in people with advanced solid tumors or pancreatic ductal adenocarcinoma (PDAC) that have a RAS mutation. The goal is to see if the combination is safe, tolerable, and effective at shrinking tumors. The trial involves about 222 participants and is conducted in two phases: first to check safety, then to measure tumor response.

What this could mean

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

Active substance
GFH276 (oral drug) combined with cetuximab or chemotherapy (nab-paclitaxel, gemcitabine, fluorouracil, leucovorin)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced solid tumors or pancreatic cancer that have a RAS mutation.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not work as hoped or could cause significant side effects. Results may not apply to all patients.

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 222 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 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 years and older

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. Age ≥ 18 years 2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor and PDAC with RAS mutation or KRAS amplification 3. At least one measurable lesion according to RECIST v1.1 4. ECOG performance status 0 or 1 5. Life expectancy \> 3 months 6. Adequate organ function 7. Willing to provide written informed consent 8. Fertile participants must use effective contraception Exclusion Criteria: 1. Other active malignancy within 3 years 2. Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor 3. History of active clinically significant cardiovascular dysfunction 4. For participants with known concomitant second oncodriver for PDAC or for solid tumors. 5. With active infection (HIV, HBV, HCV, syphilis) 6. The presence of clinical or radiological evidence of intestinal obstruction. 7. Prior anticancer therapy within 28 days or 5 half-lives 8. Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months 9. Hypersensitivity to study drugs, or inability to swallow tablets or comply with study procedures. 10. History of central nervous system (CNS)disease 11. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonia that requires treatment. 12. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.

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Conditions

The condition(s) this trial relates to.

cancer neoplasm pancreatic ductal adenocarcinoma

As listed by the trial registrant

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

Advanced solid tumors cancer Pancreatic ductal adenocarcinoma Ras mutation

How to take part

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

  1. The places running it

    17 sites in 2 countries. 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

  • Concord Cancer Centre, Concord Repatriation General Hospital, Sydney Local Health District

    Concord, New South Wales, 2139, Australia

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

  • Macquarie University / Clinical Trials Unit

    North Ryde, New South Wales, 2109, Australia

  • Monash Health (Monash Medical Centre)

    Clayton, Victoria, 3168, Australia

  • Northern Health

    Epping, Victoria, 3076, Australia

  • PASO Medical

    Frankston, Victoria, 3199, Australia

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

  • Shandong First Medical University Affiliated Tumor Hospital

    Jinan, Shandong, 250117, China

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016, China

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

    Guangzhou, Guangdong, 510120, China

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110001, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011, Australia

  • The Third Affiliated Hospital (Cancer Hospital) of Harbin Medical University

    Harbin, Heilongjiang, 150081, China

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

    Wuhan, Hubei, 430022, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041, China

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