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New pill targets aggressive tumors with genetic flaw

NCT ID NCT06710847

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase study tests an experimental oral drug (GSK4418959) in adults with advanced solid tumors that have specific genetic changes (dMMR or MSI-H). The drug works by blocking a protein (WRN) that these tumors need to survive. The study aims to see if the drug, alone or with another cancer medicine, can shrink tumors and is safe. About 14 participants will take part.

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

14 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Jun 2026

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: Parts 1, 2, and 3 inclusion criteria: * Has a histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor * Has a known dMMR/MSI-H status as determined by a certified local laboratory at the time of Pre-screening or has an unknown Mismatch repair (MMR)/ Microsatellite Instability (MSI) status at the time of Pre-screening and MMR/MSI status will be determined by central reference laboratory * Provides an archival or fresh (preferred) formalin fixed, paraffin embedded (FFPE) sample * Intends to receive GSK4418959 (alone or in combination with PD-1 inhibitor, as determined between Investigator and sponsor) as next line of treatment * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Is expected to have a minimum of 3 months life expectancy * Has adequate organ function, as defined in the protocol Parts 1 and 3 inclusion criteria: • Has histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor and has exhausted all standard of care treatment options Part 2 inclusion criteria: * Has histologically diagnosed advanced (unresectable, metastatic or recurrent) Colorectal cancer (CRC) or Endometrial cancer (EC) * Has received at least 1 but no more than 3 lines of systemic anticancer therapy for their advanced (unresectable, metastatic or recurrent) disease including at least one line of Immune checkpoint inhibitors (ICI) therapy * Has measurable disease (i.e., at least 1 target lesion) during the Screening period per RECIST 1.1, as determined by the investigator Exclusion Criteria: Parts 1, 2, and 3 exclusion criteria: * Has not recovered (i.e., to Grade ≤1 or to baseline) from prior anticancer therapy-induced AEs * Has received prior treatment with a WRN inhibitor * Is unable to swallow and retain orally administered study treatment * Has symptomatic uncontrolled brain or leptomeningeal metastases * Has a known additional malignancy that progressed or required active treatment within the last 2 years because reoccurrence of another malignancy would confound interpretation by RECIST 1.1 criteria. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cancer that is considered to be low risk for progression by the investigator * Has any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs * Has severe liver fibrosis * Has cirrhosis or current unstable liver or biliary disease * Has known hypersensitivity to any of the study interventions or any of their excipients * Has known WRN syndrome * Has an active autoimmune disease that has required systemic treatment in the past 2 years Part 3 exclusion criteria: * Has experienced any of the following with prior immunotherapy: any immune mediated adverse events (imAE) of Grade ≥3, immune-related severe neurologic events of any grade, exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or Drug rash with eosinophilia and systemic signs syndrome \[DRESS\] syndrome), or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary * Has any history of interstitial lung disease or pneumonitis

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Conditions

The condition(s) this trial relates to.

colon carcinoma colonic neoplasm colorectal cancer colorectal neoplasm endometrial cancer endometrium neoplasm mismatch repair cancer syndrome 1 rectal cancer rectal neoplasm

As listed by the trial registrant

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

Colon cancer Endometrial cancer Neoplasms, colorectal Rectal cancer Solid tumor

Contacts and locations

Locations

  • GSK Investigational Site

    Los Angeles, California, 90095, United States

  • GSK Investigational Site

    Denver, Colorado, 80218, United States

  • GSK Investigational Site

    Detroit, Michigan, 48201, United States

  • GSK Investigational Site

    New York, New York, 10016, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107, United States

  • GSK Investigational Site

    Melbourne, Victoria, 3000, Australia

  • GSK Investigational Site

    Brussels, 1200, Belgium

  • GSK Investigational Site

    Ghent, 9000, Belgium

  • GSK Investigational Site

    Leuven, 3000, Belgium

  • GSK Investigational Site

    Chiba, 277-8577, Japan

  • GSK Investigational Site

    Shizuoka, 411-8777, Japan

  • GSK Investigational Site

    Tokyo, 104-0045, Japan

  • GSK Investigational Site

    Tokyo, 135-8550, Japan

  • GSK Investigational Site

    Amsterdam, 1066 CX, Netherlands

  • GSK Investigational Site

    Daegu, 41404, South Korea

  • GSK Investigational Site

    Gyeonggi-do, 10408, South Korea

  • GSK Investigational Site

    Seoul, 03080, South Korea

  • GSK Investigational Site

    Barcelona, 08023, Spain

  • GSK Investigational Site

    Barcelona, 08035, Spain

  • GSK Investigational Site

    Madrid, 28040, Spain

  • GSK Investigational Site

    Málaga, 29010, Spain

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