320 Participants Needed

GSK5764227 for Gastrointestinal Cancer

Recruiting at 41 trial locations
UG
EG
Overseen ByEU GSK Clinical Trials Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, GSK5764227, for individuals with advanced gastrointestinal cancer that cannot be surgically removed. Researchers aim to evaluate the drug's effectiveness, safety, and how the body processes it. Participants will receive varying doses to determine the most effective and safe amount. Those with advanced colorectal or pancreatic cancer that has worsened after previous treatment may qualify for this study. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you have received immunosuppressive agents within 30 days before the study or if you require long-term use of them.

Is there any evidence suggesting that GSK5764227 is likely to be safe for humans?

Research shows that GSK5764227 is being tested for safety and effectiveness in people with advanced gastrointestinal cancer. Earlier studies have examined the safety of this treatment for patients with solid tumors, including those in the gastrointestinal area. Although specific safety details from these studies aren't provided, the main goal is to assess patient tolerance and potential side effects. As this trial is in the early stages (Phase 1 and Phase 2), it primarily focuses on determining safe dosage levels and understanding the treatment's mechanism in the body. The treatment remains under careful observation for safety, with any side effects closely monitored and recorded.12345

Why do researchers think this study treatment might be promising for gastrointestinal cancer?

Unlike the standard treatments for gastrointestinal cancers, which often include chemotherapy and targeted therapies, GSK5764227 is a new experimental drug that researchers are excited about due to its unique mechanism of action. It specifically targets cancer cells more precisely, potentially reducing damage to healthy cells. Additionally, the drug is being tested at multiple dosage levels to optimize its effectiveness and safety, which could offer more personalized treatment options for patients. This targeted approach has the potential to improve outcomes and reduce side effects compared to existing therapies.

What evidence suggests that this trial's treatments could be effective for gastrointestinal cancer?

Research has shown that GSK5764227 is under investigation as a potential treatment for advanced gastrointestinal cancers, including colorectal and pancreatic cancers. The trial features various treatment arms, each testing different doses of GSK5764227. This treatment targets specific pathways in cancer cells, potentially slowing or stopping their growth. Previous studies suggest that treatments like GSK5764227 can effectively control tumor growth in these cancers. Although the full results of these studies are not yet available, early findings are promising. This trial will further explore the treatment's effectiveness and how the body processes this new medicine.16789

Are You a Good Fit for This Trial?

This trial is for people with advanced gastrointestinal cancers that can't be removed by surgery. Participants must have had 1-2 prior treatments for colorectal cancer, show progression after the last treatment, and have at least one measurable tumor. They need to provide a fresh or archival tumor tissue sample, agree to use contraception, sign consent forms, and have good organ function with an ECOG performance status of 0 or 1.

Inclusion Criteria

I am willing to use birth control.
My organs are functioning well.
I have at least one measurable cancer lesion.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GSK5764227, either high or low dose, to evaluate efficacy and safety

17 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 months

What Are the Treatments Tested in This Trial?

Interventions

  • GSK5764227
Trial Overview The study tests GSK5764227's effectiveness and safety in individuals worldwide with advanced gastrointestinal cancer who've already tried other treatments. It aims to understand how patients respond to this new medication and how their bodies process it.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: PDAC: GSK5764227 (Dose 5)Experimental Treatment1 Intervention
Group II: CRC-B: GSK5764227 (Dose 4)Experimental Treatment1 Intervention
Group III: CRC-B: GSK5764227 (Dose 3)Experimental Treatment1 Intervention
Group IV: CRC-A: GSK5764227 (Dose 2)Experimental Treatment1 Intervention
Group V: CRC-A: GSK5764227 (Dose 1)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

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