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GSK4418959A

Clinical trials are studying GSK4418959A in people with dMMR/MSI-H solid tumors, including colorectal cancer. The trials are looking at safety, tolerability, dose selection, and early signs of anti-tumor activity. Some parts test GSK4418959A alone, and others test it with a PD-1 inhibitor.

Table of contents

Trial overview

The main study is FTIH study, which means a first-time-in-humans study. It is designed to look at the safety and early efficacy of GSK4418959A, meaning whether the treatment may help shrink or control tumors.[1]

This trial is for people with dMMR/MSI-H solid tumors, and colorectal cancer is specifically listed as a condition being studied.[1] The study status is Authorised and the planned enrollment is 69 participants.[1]

Who can participate

The trial focuses on people with solid tumors that have dMMR or MSI-H features, which are tumor traits related to DNA repair problems and many DNA changes.[1]

Colorectal cancer is one of the main conditions named in the study, and the brief summary also says that one part of the trial separately looks at endometrial cancer.[1] Endometrial cancer starts in the lining of the uterus.[1]

What the studies are measuring

In the early dose-finding parts, researchers are measuring dose-limiting toxicities, which are side effects serious enough to stop a dose from being raised further.[1]

They are also measuring treatment-emergent adverse events, which are health problems that begin or get worse after treatment starts.[1]

Other safety measures include dose interruptions, dose reductions, and stopping treatment because of side effects.[1]

For the tumor response part of the study, the main endpoint is overall response rate, which means the percentage of participants with a confirmed complete response or partial response based on RECIST 1.1 and investigator assessment.[1]

Trial phases and study parts

This is a Phase 1/2 trial, so it combines early safety work with an early look at whether the treatment may help the cancer.[1]

In Part 1, the study aims to find the maximum tolerated dose and/or the recommended dose for expansion for GSK4418959A used alone.[1]

In Part 2, the study evaluates the preliminary anti-tumor activity of GSK4418959A in colorectal cancer and separately in endometrial cancer.[1]

In Part 3, the study looks at GSK4418959A given with a PD-1 inhibitor, which is a type of cancer treatment that helps the immune system attack cancer cells.[1]

Treatments being tested

The trial includes GSK4418959A given by oral use in more than one study part.[1]

It also includes a combination arm with JEMPERLI, which is listed as a PD-1 inhibitor given by intravenous use.[1]

The study is not just asking whether the treatment works. It is also asking whether the treatment can be given safely enough to choose a dose for later research.[1]

What the results mean for patients

For patients, the most important question in this study is whether GSK4418959A can be given at a dose that is both tolerable and active against the cancer.[1]

The study is still early, so it is mainly about learning rather than proving benefit.[1] The results may help decide the best dose for future studies and show whether the treatment should be studied further in these cancers.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06710847 Phase 1/2 dMMR/MSI-H solid tumors, colorectal cancer Authorised 69

FAQ

  • What is being studied in the GSK4418959A trials? The trials are studying GSK4418959A alone and in combination with another anti-cancer treatment. The main goals are to learn about safety, tolerability, dose finding, and early tumor response.
  • Who can take part in these trials? The study is for people with dMMR/MSI-H solid tumors. Colorectal cancer is specifically mentioned, and endometrial cancer is also studied in one part of the trial.
  • What phase are the trials? These are Phase 1/2 trials. Phase 1 usually focuses on safety and dose finding, while Phase 2 looks more closely at early signs that the treatment may work.
  • What results are the researchers measuring? They are measuring dose-limiting toxicities, treatment-emergent adverse events, dose changes, and treatment stops because of side effects. They are also measuring overall response rate, which means how many people have a confirmed tumor shrinkage or disappearance.
  • Is GSK4418959A being tested with other treatments? Yes. One part of the study tests GSK4418959A with a PD-1 inhibitor called JEMPERLI. The trial aims to see whether the combination is safe and whether it may help control the cancer.

Ongoing Clinical Trials on GSK4418959A

  • Study on the Safety and Effects of GSK4418959 and Dostarlimab for Adults with Colorectal Cancer with Mismatch Repair Deficiency or High Microsatellite Instability

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium The Netherlands Spain

Glossary

  • dMMR: A short way to say mismatch repair deficient. This means the tumor has a problem fixing damaged DNA.
  • MSI-H: Microsatellite instability-high. This is a tumor feature that shows a high level of DNA changes.
  • Solid tumor: A cancer that forms a lump or mass in an organ or tissue.
  • Colorectal cancer: Cancer that starts in the colon or rectum.
  • Endometrial cancer: Cancer that starts in the lining of the uterus.
  • Phase 1/2: An early stage of clinical research. Phase 1 mainly studies safety and dose, and Phase 2 looks more closely at whether the treatment may help.
  • Dose-limiting toxicity: A side effect serious enough to limit how much of a treatment can be given.
  • Treatment-emergent adverse event: A health problem that starts or gets worse after treatment begins.
  • Overall response rate: The percentage of people whose cancer gets smaller or disappears after treatment.
  • PD-1 inhibitor: A type of cancer treatment that helps the immune system attack cancer cells.
  • Recommended dose for expansion: The dose chosen for a later part of a study after early safety testing.

References