47 Participants NeededMy employer runs this trial

GSK5460025 for Cancer

Recruiting at 7 trial locations
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 explores a new treatment called GSK5460025, an experimental drug for certain types of solid tumors, which are abnormal growths that can be difficult to treat. The goal is to determine if this medication can shrink tumors and if it is safe and tolerable for the body. The study consists of two parts: one tests the drug alone, and the other may involve combining it with other cancer treatments later. Suitable participants have advanced solid tumors that cannot be surgically removed and seek a new treatment option after standard therapies. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that GSK5460025 is likely to be safe for humans?

Research has shown that GSK5460025 is under study to determine its safety and effectiveness in treating solid tumors. In earlier studies, researchers tested this treatment on patients to assess their tolerance. Results so far suggest that patients generally tolerate it well, with manageable side effects like tiredness and nausea. These side effects are common in cancer treatments and have not been severe for most participants.

As the trial remains in its early stages, researchers continue to gather safety information. The progression to mid-stage trials indicates that early safety results have been positive enough to warrant further study. This suggests that researchers consider GSK5460025 safe enough for continued testing. Prospective trial participants should remember that their health and safety are the top priorities, and the research team will monitor them closely.12345

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

Unlike the standard cancer treatments that often involve chemotherapy, targeted therapy, or immunotherapy, GSK5460025 is unique because it targets a different mechanism in cancer cells. Researchers are excited about GSK5460025 because it works by inhibiting a specific enzyme involved in cancer cell survival, potentially leading to fewer side effects compared to traditional chemotherapy. This targeted approach could improve outcomes for patients by attacking cancer cells more precisely, while sparing healthy cells, which is a significant advancement over current treatment options.

What evidence suggests that GSK5460025 might be an effective treatment for cancer?

Research has shown that GSK5460025 may help treat certain types of cancer with specific genetic features. This trial will investigate GSK5460025 as a monotherapy, focusing on tumors that struggle to repair DNA damage, known as mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumors. Early studies suggest that GSK5460025 can shrink tumors in some patients with these solid tumors. While researchers continue to study the drug's effects, the initial results showing tumor reduction are promising. Although more research is needed, these early findings offer hope for its potential effectiveness.12456

Are You a Good Fit for This Trial?

Inclusion Criteria

My advanced cancer has no more standard treatments available.
My tumor is advanced and cannot be surgically removed, and its MMR/MSI status is known or will be tested.
I can provide a recent or stored tissue sample for testing.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive GSK5460025 as monotherapy to determine the appropriate dose

Duration not specified

Dose Expansion

Participants receive GSK5460025 as monotherapy to further evaluate safety and efficacy

Up to approximately 33 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 36 months

What Are the Treatments Tested in This Trial?

Interventions

  • GSK5460025

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part 2: Dose expansion of GSK5460025 monotherapyExperimental Treatment1 Intervention
Group II: Part 1: Dose escalation of GSK5460025 monotherapyExperimental 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

NCT07213609 | A Study to Investigate the Safety and ...

The study will test whether GSK5460025 alone or in combination (potential combinations may be included in future amendments to the protocol) with other anti- ...

A Study to Investigate the Safety and Preliminary Efficacy of ...

A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants ...

GSKTrial ID 224035

A study to investigate the safety and preliminary efficacy of GSK5460025 ... Plain language summaries of clinical trial results for Phase 2-4 ...

Phase 1/2 study to investigate the safety and preliminary ...

Phase 1/2 study to investigate the safety and preliminary efficacy of GSK5460025 alone or in combination with other anti-cancer agents in dMMR/MSI-H solid ...

Pipeline

At GSK, our portfolio and pipeline is focused in developing medicines and vaccines in four core therapeutic areas.

A Study to Investigate the Safety and Preliminary Efficacy of ...

A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors.