97 Participants NeededMy employer runs this trial

GSK5533524 for Cancer

Recruiting at 10 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 tests a new drug, GSK5533524, as a potential cancer treatment to determine a safe dose and assess how people with advanced cancers respond. Researchers aim to discover if the drug can shrink tumors or slow cancer growth. They will also study how the body processes the drug and monitor for any immune reactions. Individuals with advanced solid tumors that have not responded to standard treatments and whose cancer has progressed might be suitable candidates for this study. 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 drug.

Do I need to stop my current medications for the trial?

The trial does not specify if you must stop all current medications, but you cannot take medications that prolong the QT/QTc interval or cause certain heart issues. Also, you must not have taken certain cancer treatments or immunosuppressive drugs recently.

Is there any evidence suggesting that GSK5533524 is likely to be safe for humans?

In a previous study, researchers tested GSK5533524 in humans for the first time. They aimed to find a safe dose and assess how well participants could tolerate it. As a Phase 1 trial, the drug remains in the early stages of testing, and researchers continue to gather safety information. Consequently, there is limited data on tolerance and potential side effects. However, Phase 1 trials prioritize safety, so any serious issues would likely emerge at this stage. If the drug receives future approval, it will have undergone further testing to confirm its safety.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about GSK5533524 for cancer because it introduces a novel approach by inhibiting a specific protein crucial for cancer cell growth. Unlike traditional chemotherapy, which attacks both healthy and cancerous cells, GSK5533524 is designed to target only the cancer cells, potentially reducing side effects and improving patient quality of life. This precise targeting could lead to more effective treatments, especially for patients who have not responded well to current options like surgery, radiation, or conventional chemotherapies. By focusing on this specific protein, GSK5533524 represents a promising advancement in cancer treatment strategies.

What evidence suggests that GSK5533524 might be an effective treatment for cancer?

Research has shown that GSK5533524 is undergoing testing in individuals with advanced cancers. This trial consists of two parts: Part 1a focuses on dose escalation and backfill, while Part 1b involves dose expansion. The drug targets specific molecules in cancer cells, potentially stopping their growth or spread. Early lab and animal studies demonstrated that GSK5533524 can shrink tumors. However, limited information exists about its effects in humans, so its efficacy in people remains uncertain. The initial human trials primarily aim to understand the body's reaction to the drug and determine a safe dose.12467

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have not responded to standard treatments or who can't tolerate them. Participants must have at least one measurable tumor, good organ function, and be in generally good physical condition.

Inclusion Criteria

I have advanced cancer that does not respond to or cannot tolerate standard treatments.
My disease has gotten worse on scans during or after my last treatment.
* Has at least one target lesion per RECIST 1.1 (participants in Part 1a backfill and Part 1b).
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation & Backfill

Participants receive GSK5533524 to determine a safe dose and assess tolerance

Up to approximately 27 months

Dose Expansion

Participants receive GSK5533524 to further evaluate safety and preliminary activity

Up to approximately 27 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • GSK5533524

Trial Overview

Researchers are testing a new drug called GSK5533524, given alone or possibly with other drugs, to find the safest dose and see how well people handle it. The study also checks if the drug can shrink tumors or slow their growth.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part 1b: GSK5533524 Dose ExpansionExperimental Treatment1 Intervention
Group II: Part 1a: GSK5533524 Dose Escalation & BackfillExperimental 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

NCT07438782 | First Time in Human (FTIH) Study to ...

The purpose of this study is to investigate a new drug GSK5533524 in adults with certain advanced cancers to find a safe dose and learn how well people ...

GSKTrial ID 300163

Trial description: The purpose of this study is to investigate a new drug GSK5533524 in adults with certain advanced cancers to find a safe ...

GSK5533524 for Cancer · Recruiting Participants for Phase ...

The purpose of this study is to investigate a new drug GSK5533524 in adults with certain advanced cancers to find a safe dose and learn how well people ...

GSK's New Cancer Drug GSK5533524 Enters First‑in‑ ...

GlaxoSmithKline has launched a Phase 1, first‑in‑human study called “A Phase 1, Open‑label, Multicenter Study of GSK5533524 Alone or in ...

Pipeline

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

A Phase 1, Open-label, Multicenter Study of GSK5533524 ...

The purpose of this study is to investigate a new drug GSK5533524 in adults with certain advanced cancers to find a safe dose and learn how ...

Pipeline assets and clinical trials appendix - Q1 2026

To evaluate the safety, reactogenicity and immunogenicity profile of iNTS-GMMA vaccine in adults, children and infants (Ghana).