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New pill targets Hard-to-Treat cancers in early trial

NCT ID NCT07198321

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests an experimental oral drug called GFH276 in people with advanced solid tumors that have RAS mutations, including pancreatic, lung, and colorectal cancers. The trial has two parts: Phase 1 finds the safest dose, and Phase 2 checks if the drug shrinks tumors. About 450 adults aged 18-75 will participate across multiple centers.

What this could mean

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

Active substance
GFH276 (an oral drug targeting RAS-mutant cancers)
What this could lead to
If successful, this could lead to a new oral treatment option for people with hard-to-treat cancers like pancreatic, lung, and colorectal cancer that have specific RAS mutations.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 450 participants, so the drug may not prove effective or safe enough for wider use. Side effects could be significant, and the drug may only work for a subset of 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 450 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

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 ≥3 moths 5. Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion. 6. Adequate laboratory parameters during the screening period. Exclusion Criteria: 1. Active brain metastases. 2. Prior treatment with a PAN-RAS 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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Conditions

The condition(s) this trial relates to.

cancer colorectal cancer colorectal carcinoma colorectal neoplasm neoplasm non-small cell lung carcinoma pancreatic adenocarcinoma pancreatic ductal adenocarcinoma

As listed by the trial registrant

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

Cancer CRC (colorectal cancer) NSCLC PDAC

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

  • Sun-Yat sen university cancer center

    Guangzhou, Guangdong, 510000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.