GSK3745417 for Cancer

Not currently recruiting at 13 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Must not be taking: Immunosuppressants, Checkpoint inhibitors

Disqualifiers: Autoimmune, Liver disease, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer treatment, GSK3745417, for individuals with solid tumors unresponsive to standard treatments. The researchers aim to determine the safety and efficacy of this drug alone and in combination with dostarlimab. Participants must have a solid tumor that has recurred or does not respond to existing therapies and must provide a fresh biopsy for the study. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you require systemic immunosuppressive treatment or have taken certain cancer therapies recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that GSK3745417 is generally safe for patients, meaning most people can take it without serious problems. In studies, it has shown promise in helping the immune system fight tumors.

When combined with dostarlimab, research suggests it can effectively control cancer. Dostarlimab has been used in other treatments and has slowed cancer growth. This suggests that using them together might be safe, based on past experiences with these drugs.

Since this trial is in an early phase, the main focus is on assessing the treatment's safety for people. At this stage, researchers closely monitor the new treatment to evaluate how well people tolerate it and to determine the best dose. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about GSK3745417 because it offers a novel approach to cancer treatment. Unlike traditional therapies such as chemotherapy and radiation, which broadly target rapidly dividing cells, GSK3745417 is designed to specifically target and activate the immune system to attack cancer cells. This treatment works by modulating immune pathways, potentially leading to fewer side effects and more precise targeting of cancerous cells. Additionally, when combined with dostarlimab, an immune checkpoint inhibitor, GSK3745417 may enhance the body's natural ability to fight cancer, offering hope for more effective and personalized treatment options.

What evidence suggests that GSK3745417 might be an effective treatment for cancer?

Research has shown that GSK3745417 could be a promising cancer treatment because it helps the immune system fight tumors. Early data suggests it increases proinflammatory cytokines, which can help control tumor growth. In this trial, some participants will receive GSK3745417 alone, while others will receive it with dostarlimab, an existing cancer treatment. Dostarlimab has significantly improved survival rates in some cancers, such as endometrial cancer. This combination aims to leverage the strengths of both treatments to potentially provide a stronger defense against cancer. ^{1 2 5 6 7}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that have worsened or not responded to existing treatments can join this trial. They must be at least 18, have a confirmed diagnosis, measurable disease, good organ function, and an ECOG performance status of 0-1. Women who can bear children need to use effective contraception and cannot be pregnant or breastfeeding.

Inclusion Criteria

I am fully active or can carry out light work.

My organs are functioning well.

I am able to understand and sign the consent form.

Exclusion Criteria

I have had vasculitis in the past.

I haven't taken any immune checkpoint inhibitors in the last 28 days.

I have had symptoms of pericarditis in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive GSK3745417 alone or with dostarlimab to evaluate safety, tolerability, and establish a recommended dose

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GSK3745417

Trial Overview

The study is testing GSK3745417 alone (Part 1A) or combined with dostarlimab (Part 2A) in patients with stubborn solid tumors. It's in the first phase where they're figuring out safe doses and checking how well it works by gradually increasing the dose.

How Is the Trial Designed?

Group I: Part 2A: Participants receiving GSK3745417 + dostarlimab, Dose escalation Cohort Experimental Treatment 2 Interventions

Group II: Part 1A: Participants receiving GSK3745417, Dose-escalation Cohort Experimental Treatment 1 Intervention

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

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10994474/

The Development of STING Agonists and Emerging ...

STING agonists are a new class of agents that activate the host response immune response to improve tumor control.

2.

mycancergenome.org

mycancergenome.org/content/clinical_trials/NCT03843359/

Clinical Trial: NCT03843359

In Part 1B and 2B, subjects will receive a single dose level of GSK3745417 as identified based on data from Part 1, either alone or in ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03843359

NCT03843359 | A First Time in Human (FTIH) Study of ...

This study aims to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered alone ...

4.

onderzoekmetmensen.nl

onderzoekmetmensen.nl/en/node/51352/pdf

Phase 1, open label study of intravenous GSK3745417 to ...

Preliminary data from the 208850 study have shown that administration of GSK3745417 results in increased proinflammatory cytokine production ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7466854/

Trial watch: STING agonists in cancer therapy - PMC

GSK3745417 is currently being tested as monotherapy or combined with the PD-1 blocking antibody pembrolizumab, in patients with advanced, refractory/relapsed ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11483357/

Clinical applications of STING agonists in cancer ...

Early data suggest that GSK3745417 has a manageable safety profile, with potential for inducing anti-tumor immune responses (43). 3.2.4. E ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05424380

Study Details | NCT05424380 | A Phase 1, Open Label ...

A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D and Schedule ...