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Gsk6097608

Clinical trials are studying Gsk6097608 in people with certain advanced cancers. These trials look at safety and how well Gsk6097608 works in combination with other immunotherapy drugs in first-line treatment for non-small cell lung cancer and head and neck cancer.

Table of Contents

Clinical trial overview

Gsk6097608 is being tested in interventional studies, which means researchers are giving study treatments and then measuring results.[1][2]

Both available trials are Phase 2 studies, so they are mainly looking for early signs of benefit while also checking safety.[1][2]

The studies are authorised and focus on advanced cancers in adults.[1][2]

Previously untreated advanced or metastatic non-small cell lung cancer study

NCT05565378 is a Phase 2 platform study in participants with previously untreated, advanced or metastatic non-small cell lung cancer.[1]

This study includes Gsk6097608 with other immunotherapy drugs and is designed to monitor the safety of novel combinations.[1]

The planned enrollment is 340 participants.[1]

The main safety endpoint is the incidence of TEAEs and SAEs, which means how often treatment-related side effects and serious side effects happen.[1]

The study also measures side effects that lead to dose changes, dose delays, or stopping study treatment.[1]

PD-L1 positive recurrent or metastatic head and neck cancer study

Trial 2023-503428-24-00 is a Phase 2 platform study in participants with PD-L1 positive recurrent or metastatic squamous cell carcinoma of the head and neck.[2]

This study is testing Gsk6097608 in first-line treatment, meaning it is being studied as an initial treatment option for this cancer group.[2]

The planned enrollment is 360 participants.[2]

The brief summary says the study aims to evaluate the antitumor activity of novel immunotherapy combinations compared with dostarlimab in participants with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma.[2]

What the trials measure

The lung cancer study measures safety as its primary outcome.[1]

Its main endpoint is the number of treatment-emergent adverse events and serious adverse events, plus events that cause dose modification or treatment discontinuation.[1]

The head and neck cancer study measures confirmed objective response rate, or ORR, as its primary outcome.[2]

Confirmed ORR means the percentage of participants who have a confirmed complete response or partial response based on RECIST 1.1, a standard way to measure tumor shrinkage.[2]

Who can join these studies

These trials are for adults with specific advanced cancers, not for all cancer types.[1][2]

The lung cancer study is for people who have previously untreated advanced or metastatic non-small cell lung cancer.[1]

The head and neck study is for people with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma.[2]

Because the studies are platform trials, they are built to test treatment combinations within a larger research plan.[1][2]

Key terms for patients

  • Authorised means the study has been approved to move forward in the listed setting.[1][2]
  • Metastatic means the cancer has spread to other parts of the body.[1][2]
  • Recurrent means the cancer has come back after treatment.[2]
  • First-line treatment means the first treatment given for the cancer.[2]
  • Complete response means no signs of cancer are seen on testing.[2]
  • Partial response means the cancer has shrunk, but not disappeared completely.[2]
Trial ID Phase Condition studied Status Enrollment
NCT05565378 Phase 2 Previously untreated advanced/metastatic non-small cell lung cancer Authorised 340
2023-503428-24-00 Phase 2 PD-L1 positive recurrent/metastatic squamous cell carcinoma of the head and neck Authorised 360

FAQ

  • What is Gsk6097608 being studied for in these trials? Gsk6097608 is being studied in combination with other immunotherapy drugs. The trials aim to see whether these combinations are safe and whether they help treat advanced cancers.
  • Which conditions are being studied? One trial is in previously untreated advanced or metastatic non-small cell lung cancer. Another trial is in PD-L1 positive recurrent or metastatic squamous cell carcinoma of the head and neck.
  • What phase are the trials? Both trials are Phase 2 studies. Phase 2 trials often look at early signs of how well a treatment works while also continuing to monitor safety.
  • Who may take part in these studies? The trials are for adults with specific advanced cancers. One study is for people who have not yet received treatment for advanced or metastatic non-small cell lung cancer, and the other is for people with PD-L1 positive recurrent or metastatic head and neck cancer.
  • What results are the trials measuring? One trial measures treatment-related side effects, including serious side effects and changes that lead to dose delays or stopping treatment. The other trial measures confirmed tumor response, including complete or partial response based on RECIST 1.1, which is a standard way to measure tumor shrinkage.

Ongoing Clinical Trials on Gsk6097608

  • Testing Drug Combinations with GSK4381562A, GSK6097608, GSK4428859 and Dostarlimab in Patients with PD-L1 Positive Head and Neck Cancer That Has Spread or Returned

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Denmark Finland France Germany Greece Hungary +6

  • Study of Immunotherapy Combinations with GSK4428859, Dostarlimab, and GSK6097608 for Patients with Advanced Non-Small Cell Lung Cancer

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Finland France Germany Greece Hungary +5

Glossary

  • Advanced cancer: Cancer that has spread or is not limited to one small area.
  • Metastatic: Cancer that has spread from where it first started to other parts of the body.
  • Non-small cell lung cancer: The most common type of lung cancer.
  • Squamous cell carcinoma: A type of cancer that starts in flat cells lining many parts of the body, including the head and neck area.
  • PD-L1 positive: A test result showing that the cancer has PD-L1, a marker used to help choose some immunotherapy treatments.
  • First-line treatment: The first treatment given for a cancer after diagnosis.
  • Phase 2: A trial stage that looks at early signs of benefit and continues to check safety.
  • Interventional study: A study where participants receive one or more treatments so researchers can compare outcomes.
  • Primary outcome: The main result researchers plan to measure in a trial.
  • RECIST 1.1: A standard system used to measure whether tumors shrink, stay the same, or grow.
  • Objective response rate: The percentage of participants whose cancer shrinks in a confirmed way.
  • TEAEs: Treatment-emergent adverse events, meaning side effects that start or get worse after treatment begins.

References