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New hope for stomach and bowel cancers? experimental drug enters human trials

NCT ID NCT06885034

Disease control Sponsor: GlaxoSmithKline 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 04, 2026 · Updated 5 times

Summary

This study tests an experimental drug called GSK5764227, given alone or with other treatments, in 320 people with advanced gastrointestinal cancers that have not responded to prior therapy. The main goal is to see if the drug can shrink tumors and how safe it is. It is an early-stage trial, so results will help determine if larger studies are warranted.

What this could mean

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

Active substance
GSK5764227 (an experimental biologic drug)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced gastrointestinal cancers that have stopped responding to prior therapies.
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 have unexpected 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 451 people

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

Started

Jun 2025

Expected to finish

Jan 2029

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: Participants are eligible to be included in the study only if all of the following criteria apply: * Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place years of age at the time of signing the informed consent form (ICF). CRC Cohort * Has histologically confirmed unresectable, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum (histology defined by World Health Organization (WHO) classification). PDAC Cohort * Has histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (histology defined by WHO classification). All Cohorts * Is willing to use adequate contraception. * Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol. * Has an ECOG performance status of 0 or 1. * Has adequate organ function. Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: * Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \[e.g., breast, cervix, bladder\] that have been resected with no evidence of disease. * Has had any major surgery within 28 days prior to randomization or first dose of study intervention, depending on sub-cohort/cohort assignment * Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant. * Has severe, uncontrolled or active cardiovascular disorders. * Has serious or poorly controlled hypertension. * Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose. * Has untreated brain or Central nervous system (CNS) metastases or brain/CNS metastases that have progressed. * Has evidence of current ILD/non-infectious pneumonitis or a prior history of ILD/non-infectious pneumonitis requiring high-dose glucocorticoids Or suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging. * Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to Grade 1 or to the baseline status preceding prior therapy. * Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload. * Is pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

colorectal adenocarcinoma colorectal neoplasm digestive system neoplasm pancreatic adenocarcinoma

As listed by the trial registrant

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

Gastrointestinal neoplasms

How to take part

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

  1. The places running it

    85 sites in 19 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

  • GSK Investigational Site

    RECRUITING

    Los Alamitos, California, 90505, United States

  • GSK Investigational Site

    RECRUITING

    Los Angeles, California, 90089, United States

  • GSK Investigational Site

    RECRUITING

    Santa Monica, California, 90404, United States

  • GSK Investigational Site

    RECRUITING

    Whittier, California, 90602, United States

  • GSK Investigational Site

    RECRUITING

    Aurora, Colorado, 80045, United States

  • GSK Investigational Site

    RECRUITING

    New York, New York, 10021, United States

  • GSK Investigational Site

    RECRUITING

    New York, New York, 10065, United States

  • GSK Investigational Site

    RECRUITING

    Durham, North Carolina, 27710, United States

  • GSK Investigational Site

    RECRUITING

    Houston, Texas, 77479, United States

  • GSK Investigational Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • GSK Investigational Site

    RECRUITING

    Wenatchee, Washington, 98801, United States

  • GSK Investigational Site

    RECRUITING

    Madison, Wisconsin, 53792-0001, United States

  • GSK Investigational Site

    RECRUITING

    Heidelberg, Victoria, 3084, Australia

  • GSK Investigational Site

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • GSK Investigational Site

    RECRUITING

    Bonheiden, 2820, Belgium

  • GSK Investigational Site

    RECRUITING

    Brussels, 1200, Belgium

  • GSK Investigational Site

    RECRUITING

    Leuven, 3000, Belgium

  • GSK Investigational Site

    RECRUITING

    Roeselare, 8800, Belgium

  • GSK Investigational Site

    RECRUITING

    Porto Alegre, 90850-170, Brazil

  • GSK Investigational Site

    RECRUITING

    São Paulo, 01246-000, Brazil

  • GSK Investigational Site

    RECRUITING

    Teresina, 64049-200, Brazil

  • GSK Investigational Site

    RECRUITING

    Calgary, Alberta, T2N 5G2, Canada

  • GSK Investigational Site

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, H2X 0C1, Canada

  • GSK Investigational Site

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • GSK Investigational Site

    RECRUITING

    Helsinki, 00029, Finland

  • GSK Investigational Site

    RECRUITING

    Helsinki, 00180, Finland

  • GSK Investigational Site

    RECRUITING

    Kuopio, 70210, Finland

  • GSK Investigational Site

    RECRUITING

    Tampere, 33520, Finland

  • GSK Investigational Site

    RECRUITING

    Dijon, 21079, France

  • GSK Investigational Site

    RECRUITING

    Marseille, 13273, France

  • GSK Investigational Site

    RECRUITING

    Paris, 75010, France

  • GSK Investigational Site

    RECRUITING

    Paris, 75012, France

  • GSK Investigational Site

    RECRUITING

    Paris, 75015, France

  • GSK Investigational Site

    RECRUITING

    Poitiers, 86021, France

  • GSK Investigational Site

    RECRUITING

    Rennes, 35042, France

  • GSK Investigational Site

    RECRUITING

    Villejuif, 94805, France

  • GSK Investigational Site

    RECRUITING

    Bochum, 44791, Germany

  • GSK Investigational Site

    RECRUITING

    Düsseldorf, 40225, Germany

  • GSK Investigational Site

    RECRUITING

    Frankfurt, 60488, Germany

  • GSK Investigational Site

    RECRUITING

    Lübeck, 23562, Germany

  • GSK Investigational Site

    RECRUITING

    München, 81737, Germany

  • GSK Investigational Site

    RECRUITING

    Milan, 20133, Italy

  • GSK Investigational Site

    RECRUITING

    Milan, 20162, Italy

  • GSK Investigational Site

    RECRUITING

    Pisa, 56126, Italy

  • GSK Investigational Site

    RECRUITING

    Roma, 00168, Italy

  • GSK Investigational Site

    RECRUITING

    Aichi, 464-8681, Japan

  • GSK Investigational Site

    RECRUITING

    Chiba, 277-8577, Japan

  • GSK Investigational Site

    RECRUITING

    Hokkaido, 060-8648, Japan

  • GSK Investigational Site

    RECRUITING

    Osaka, 565-0871, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 104-0045, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 135-8550, Japan

  • GSK Investigational Site

    RECRUITING

    Tuxtla Gutiérrez, Chiapas, 29090, Mexico

  • GSK Investigational Site

    RECRUITING

    Cuernavaca, Morelos, 62448, Mexico

  • GSK Investigational Site

    RECRUITING

    Mexico City, 03100, Mexico

  • GSK Investigational Site

    RECRUITING

    Mexico City, 06100, Mexico

  • GSK Investigational Site

    RECRUITING

    San Pedro Garza García, 66260, Mexico

  • GSK Investigational Site

    RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • GSK Investigational Site

    RECRUITING

    Maastricht, 6229 HX, Netherlands

  • GSK Investigational Site

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • GSK Investigational Site

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • GSK Investigational Site

    RECRUITING

    Lrenskog, 1474, Norway

  • GSK Investigational Site

    RECRUITING

    Oslo, 0407, Norway

  • GSK Investigational Site

    RECRUITING

    Stavanger, 4011, Norway

  • GSK Investigational Site

    RECRUITING

    La Villa de Los Santos, Los Santos Province, 6040, Panama

  • GSK Investigational Site

    RECRUITING

    Punta Pacifica Panama City Panama, Panama

  • GSK Investigational Site

    RECRUITING

    Brzozów, 36-200, Poland

  • GSK Investigational Site

    RECRUITING

    Koszalin, 75-581, Poland

  • GSK Investigational Site

    RECRUITING

    Warsaw, 02-034, Poland

  • GSK Investigational Site

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 110 744, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 135-710, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 138-736, South Korea

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08041, Spain

  • GSK Investigational Site

    RECRUITING

    HebrOn, 08035, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28007, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28034, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28041, Spain

  • GSK Investigational Site

    RECRUITING

    Pamplona, 31008, Spain

  • GSK Investigational Site

    RECRUITING

    Santander, 39011, Spain

  • GSK Investigational Site

    RECRUITING

    Zaragoza, 50009, Spain

  • GSK Investigational Site

    RECRUITING

    Gothenburg, SE-413 45, Sweden

  • GSK Investigational Site

    RECRUITING

    Lund, 22185, Sweden

  • GSK Investigational Site

    RECRUITING

    Stockholm, SE-118 83, Sweden

  • GSK Investigational Site

    RECRUITING

    Uppsala, 751 85, Sweden

  • GSK Investigational Site

    RECRUITING

    Manchester, M20 4BX, United Kingdom

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