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GSK5764227

Clinical trials are studying GSK5764227 in people with advanced solid tumors, gastrointestinal cancers, and relapsed small cell lung cancer. These studies are looking at safety, tolerability, and antitumor activity, and they include patients who have already received prior treatment. The trials are in Phase 1, Phase 1b/2, and Phase 3.

Table of contents

Trials overview

Three authorised clinical trials are investigating GSK5764227 in cancer. The studies are in Phase 1, Phase 1b/2, and Phase 3, and they focus on different groups of patients with advanced disease.[1][2][3]

Across the program, the trials study people with previously treated advanced unresectable or metastatic gastrointestinal solid tumors, relapsed small cell lung cancer, and other advanced solid tumors.[1][2][3]

Gastrointestinal tumors study

NCT06885034 is a Phase 1 interventional study in participants with previously treated advanced unresectable or metastatic gastrointestinal solid tumors.[1]

The title and brief summary show that the study includes parts for advanced unresectable colorectal cancer and advanced unresectable pancreatic ductal adenocarcinoma, which is a type of pancreatic cancer.[1]

The trial is designed to evaluate the clinical efficacy of GSK5764227 given alone, including different dosing schedules in colorectal cancer, and to assess activity in pancreatic ductal adenocarcinoma.[1]

The main endpoint is confirmed overall response rate, meaning the share of participants whose best response is a confirmed complete response or partial response based on RECIST 1.1, an imaging-based system used to measure tumor change.[1]

Small cell lung cancer study

Trial 2025-521627-78-00 is a Phase 3, multicenter, randomized, open-label study in participants with relapsed small cell lung cancer.[2]

This study compares GSK5764227 with topotecan, which is the control treatment in the trial.[2]

The main goal is to compare antitumor activity between the two treatments in a larger patient group.[2]

The primary outcomes are ORR, measured by blinded independent central review using RECIST 1.1, and overall survival, which is the time from randomization until death from any cause.[2]

Combination study in advanced solid tumors

Trial 2025-522274-37-00 is a Phase 1b/2 study of GSK5764227 in combination with standard of care or other agents in participants with advanced solid tumors.[3]

The brief summary states that the study aims to find the maximum tolerated dose and the maximum administered dose, and to evaluate safety and tolerability when GSK5764227 is given with other treatments.[3]

The treatment list includes several partner medicines used in different combinations, such as bendafolin, 5-fluorouracil, calciumfolinat, Xtandi, and Zirabev, showing that the study explores combination treatment strategies.[3]

The main safety endpoint includes the incidence of adverse events, including serious adverse events, dose-limiting toxicities, and changes in safety measures such as vital signs, body weight, laboratory tests, heart testing with ECG, and ECOG performance status.[3]

Main endpoints and what they mean

The trials measure different endpoints depending on the study phase and goal.[1][2][3]

  • Confirmed ORR: this shows how many participants have a confirmed tumor response, such as complete response or partial response.[1][2]
  • Overall survival: this measures how long participants live after the study start point or randomization.[2]
  • Safety and tolerability: this looks at side effects, including serious events and events that force a dose change.[3]
  • DLTs: these are side effects that may limit the dose that can be safely given.[3]
  • Vital signs, lab tests, ECG, and ECOG status: these help researchers track the body’s reaction to treatment and general physical condition.[3]

Who can participate

Each trial has its own eligibility rules, but the common theme is advanced cancer that has already been treated before.[1][2][3]

The gastrointestinal study includes people with advanced unresectable or metastatic gastrointestinal solid tumors, including colorectal cancer and pancreatic ductal adenocarcinoma.[1]

The lung cancer study includes participants with relapsed small cell lung cancer.[2]

The combination study includes participants with advanced solid tumors, without limiting the program to one cancer type in the data provided.[3]

Trial phases and design

Phase 1 studies are early trials that mainly look at safety, dose, and initial signs of activity.[1][3]

Phase 1b/2 studies combine early safety work with a first deeper look at whether the treatment may help patients.[3]

Phase 3 studies are larger trials that compare treatments and look at stronger evidence of benefit, such as overall survival and response rate.[2]

In this program, one study is open-label and randomized, meaning participants are assigned by chance and both the researchers and participants know which treatment is given.[2]

The available trial data show that GSK5764227 is being tested both alone and with other treatments, depending on the cancer type and trial design.[1][3]

Trial ID Phase Condition studied Status Enrollment
NCT06885034 Phase 1 Previously treated advanced unresectable or metastatic gastrointestinal solid tumors, including colorectal cancer and pancreatic ductal adenocarcinoma Authorised 316
2025-521627-78-00 Phase 3 Relapsed small cell lung cancer Authorised 300
2025-522274-37-00 Phase 1 Advanced solid tumors Authorised 72

FAQ

  • What is being studied in the GSK5764227 trials? The trials are testing GSK5764227 alone and in combination with other treatments. They are looking at whether it can help control cancer and how safe it is.
  • Who can take part in these studies? The studies include adults with previously treated advanced unresectable or metastatic gastrointestinal solid tumors, advanced solid tumors, or relapsed small cell lung cancer. Each trial has its own eligibility rules.
  • What phases are the GSK5764227 trials in? The trial program includes Phase 1, Phase 1b/2, and Phase 3 studies. Early-phase trials focus more on safety and dose finding, while Phase 3 compares GSK5764227 with another treatment.
  • What conditions are being studied? The studies involve gastrointestinal neoplasms, lung neoplasms, and other advanced solid tumors. Specific groups include colorectal cancer, pancreatic ductal adenocarcinoma, and small cell lung cancer.
  • What results are the researchers measuring? The trials measure outcomes such as confirmed overall response rate, overall survival, safety problems, and dose-limiting toxicities. Some studies also track vital signs, lab tests, heart tests, and physical function.

Sperimentazioni cliniche in corso su GSK5764227

  • Studio sul GSK5764227 in combinazione con altri farmaci per pazienti con tumori solidi avanzati

    In arruolamento

    1 1 1
    Malattie in studio:
    Farmaci in studio:
    Spagna

  • Studio di confronto tra GSK5764227 e topotecan in pazienti con carcinoma polmonare a piccole cellule recidivato per valutare l’efficacia del trattamento

    In arruolamento

    1 1 1 1
    Farmaci in studio:
    Bulgaria Finlandia Francia Germania Grecia Ungheria +7

  • Studio dell’efficacia e sicurezza di GSK5764227 in pazienti con tumori gastrointestinali avanzati non operabili o metastatici precedentemente trattati

    In arruolamento

    1 1
    Malattie in studio:
    Farmaci in studio:
    Belgio Finlandia Francia Germania Italia Paesi Bassi +4

  • Studio di fase 1b/2 sulla sicurezza e l’efficacia di GSK5764227 in pazienti adulti con sarcoma avanzato non resecabile precedentemente trattato

    Arruolamento non iniziato

    1 1
    Malattie in studio:
    Farmaci in studio:
    Francia

Glossario

  • Advanced cancer: Cancer that has grown far enough to be hard to remove with surgery or has spread to other parts of the body.
  • Unresectable: Not able to be removed completely with surgery.
  • Metastatic: Cancer that has spread from where it started to another part of the body.
  • Solid tumor: A lump or mass of cancer cells in an organ or tissue, not a cancer of the blood.
  • Phase 1: An early clinical trial phase that mainly checks safety, side effects, and dose.
  • Phase 1b/2: A study phase that looks at safety and also begins to see whether the treatment may work.
  • Phase 3: A later trial phase that compares a study treatment with another treatment in a larger group of people.
  • Overall response rate (ORR): The percentage of participants whose cancer shrinks or disappears in a confirmed way.
  • Overall survival (OS): The length of time from a set starting point, such as randomization, until death from any cause.
  • Dose-limiting toxicities (DLTs): Side effects serious enough to limit how much of a treatment can be given.
  • Randomization: Assigning participants by chance to different treatment groups.
  • RECIST 1.1: A standard way doctors and researchers measure whether a tumor is shrinking, staying stable, or growing.

Riferimenti

  1. https://studi-clinici.it/studio/studio-dellefficacia-e-sicurezza-di-gsk5764227-in-pazienti-con-tumori-gastrointestinali-avanzati-non-operabili-o-metastatici-precedentemente-trattati/
  2. https://clinicaltrials.gov/study/2025-521627-78-00
  3. https://clinicaltrials.gov/study/2025-522274-37-00