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New cancer drug enters early human testing for advanced solid tumors

NCT ID NCT07438782

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Updated 2 times

Summary

This early-phase study tests a new drug called GSK5533524, alone or with other cancer treatments, in adults with advanced solid tumors that have stopped responding to standard therapies. The main goals are to find a safe dose and see if the drug can shrink tumors or slow cancer growth. About 97 participants will take part to help researchers decide the best dose for future studies.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 97 people

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

Started

Mar 2026

Expected to finish

Feb 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: * Is at least 18 years of age or the legal age of consent * Has histologically or cytologically confirmed advanced/metastatic solid tumor that is refractory to standard therapy, for which no standard treatment is available, or who is intolerant to established standard of care therapies. * Has documented disease progression based on radiologic imaging, during or after most recent line of treatment. * Has at least one target lesion per RECIST 1.1 (participants in Part 1a backfill and Part 1b). * Has an Eastern Cooperative Oncology Group performance status of 0 or 1 and no deterioration in the 2 weeks before enrollment. * Has adequate organ function. Exclusion Criteria: * Has a history of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, congestive heart failure or clinically significant arrhythmia not controlled by Standard of care therapy. * Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion. * Has untreated brain or central nervous system metastases or metastases that have progressed * Has a Grade ≥2 corneal epithelial condition. * Has any active renal condition * Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening. * 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 a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or current ILD/pneumonitis. * Has a lung-specific intercurrent clinically significant illness * Has FEV1 \<50% predicted * Has chronic enteritis or inflammatory bowel disease or any history of clinically significant bleeding of gastrointestinal tract or clinically significant obstruction and/or perforation and/or fistulae of GI tract. * Has a known hypersensitivity to any component of GSK5533524 or its excipients. * Has history of severe allergies, or severe infusion related reactions, or idiosyncrasy to recombinant humanized proteins. * Has received any cytotoxic chemotherapy drugs, or other anti-tumor drugs within 28 days prior to the first dose of study drug. * Has received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study intervention. * Has received immunosuppressive agents or required long-term glucocorticoid therapy within 30 days prior to first dose of study treatment. * The use of concomitant medications known to prolong the QT/QTc interval or potentially cause torsades de pointes. * Has corrected QT interval by Fridericia formula (QTcF) \>470 msec or QTcF \>480 msec for participants with bundle branch block. * Has a left ventricular ejection fraction (LVEF) \< 50%. * Has risk factors for prolonged QT/QTc or TdP, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death of any direct relative under 40 years old.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    16 sites in 6 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

    Philadelphia, Pennsylvania, 19107, United States

  • GSK Investigational Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • GSK Investigational Site

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • GSK Investigational Site

    RECRUITING

    Helsinki, 00029, Finland

  • GSK Investigational Site

    RECRUITING

    Saitama, 350-1298, Japan

  • GSK Investigational Site

    RECRUITING

    Shizuoka, 411-8777, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 104-0045, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 135-8550, Japan

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08035, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28009, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28027, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28041, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28050, Spain

  • GSK Investigational Site

    RECRUITING

    Cambridge, CB2 2QQ, United Kingdom

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