GSK5764227 for Advanced Cancer

Recruiting at 39 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Must not be taking: B7-H3 agents, Immunosuppressants

Disqualifiers: Brain metastasis, Cardiac abnormalities, Autoimmune disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

316 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called GSK5764227 for individuals with advanced or metastatic solid tumors. Researchers aim to determine the safety and effectiveness of GSK5764227 both alone and in combination with other cancer drugs. For those with advanced cancer who have not responded to standard treatments, this trial might be suitable. 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, it mentions that participants should not have received certain anticancer therapies within 28 days before starting the study treatment. It's best to discuss your current medications with the study team to get a clear answer.

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

Research shows that GSK5764227 is generally safe and yields promising results for patients with advanced solid tumors. In ongoing studies involving over 200 patients, most tolerated GSK5764227 well, experiencing no serious side effects. Some did have side effects, but these were usually mild or manageable.

The FDA has granted GSK5764227 a breakthrough therapy designation for treating extensive-stage small cell lung cancer. This designation indicates that early research suggests the treatment could be beneficial, signaling its potential safety and effectiveness.

In these studies, researchers are testing GSK5764227 both alone and with other medicines. This approach helps determine its efficacy as a standalone treatment and in combination with others. Overall, early findings suggest GSK5764227 is well-tolerated, but like any new treatment, it carries some risks. Participating in clinical trials can enhance understanding of these risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about GSK5764227 for advanced cancer because it offers a novel approach to treatment. Unlike traditional chemotherapy and immunotherapy, which often target all rapidly dividing cells or boost the immune system broadly, GSK5764227 works by a new mechanism that specifically targets cancer cell pathways. This precision approach has the potential to reduce side effects and improve effectiveness compared to existing treatments. Additionally, the study is exploring both monotherapy and combination therapy options, potentially enhancing its versatility and impact on various cancer types.

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

Research has shown that GSK5764227, which participants in this trial may receive, may help treat certain advanced cancers. In studies, patients with a widespread form of small cell lung cancer experienced significant tumor shrinkage. Specifically, 96.2% of patients with visible tumors had a reduction in tumor size. The treatment also extended the time patients lived without their cancer worsening, with many experiencing no disease progression for at least three months. Additionally, the FDA has given special recognition to GSK5764227, highlighting its potential. These findings suggest GSK5764227 could be an effective option for some cancer patients. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors. Specific eligibility criteria are not provided, but typically participants must have measurable disease and adequate organ function, and may need to meet certain lab value thresholds.

Inclusion Criteria

Has measurable disease (i.e., at least 1 target lesion) per RECIST v1.1

Has a life expectancy >12 weeks

My organs are working well.

Exclusion Criteria

My heart test shows abnormal rhythms or I have a weak heart.

My cancer has spread to my brain.

I have been treated with specific medications before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose Escalation

Participants receive GSK5764227 alone or in combination with other medicines to determine the safety and tolerability at different dose levels

Up to approximately 33 months

Phase 1b: Dose Expansion

Participants receive GSK5764227 monotherapy to further evaluate safety and clinical activity

Up to approximately 27 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GSK5764227

Trial Overview The study is testing GSK5764227's safety, how well it's tolerated by patients, its effectiveness against tumors, and how the body processes it at various doses. Topotecan is also being used; possibly as a comparison or in combination.

How Is the Trial Designed?

Group I: Phase 1b- Dose optimisation/ expansion- GSK5764227 Monotherapy Experimental Treatment 1 Intervention

Group II: Phase 1a: Dose escalation-GSK5764227 Monotherapy Experimental Treatment 1 Intervention

Group III: Phase 1a- Dose escalation- Combination therapy Experimental Treatment 8 Interventions

GSK5764227 is already approved in United States, European Union for the following indications:

Approved in United States as GSK5764227 for:

• Relapsed or refractory osteosarcoma
• Extensive-stage small-cell lung cancer

Approved in European Union as GSK5764227 for:

• Relapsed or refractory extensive-stage small-cell lung cancer

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. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.TPS847

A phase 1 dose escalation/expansion study of ... The current study will evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of GSK'227 in patients with solid tumors, including GI cancers, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06551142

NCT06551142 | A Study of GSK5764227 in Participants ... The goal of this study is to assess the safety, tolerability, clinical activity and pharmacokinetics of GSK5764227. The study will also see how the levels ...

3. onclive.com onclive.com/view/fda-grants-btd-to-gsk5764227-for-extensive-stage-small-cell-lung-cancer

FDA Grants BTD to GSK5764227 for Extensive-Stage ... Moreover, the median progression-free survival (PFS) was 4.7 months (95% CI, 1.4-not applicable) and the 3-month PFS rate was 72.7% (95% CI, ...

4. targetedonc.com targetedonc.com/view/gsk5764227-gains-fda-breakthrough-therapy-designation-in-es-sclc

GSK5764227 Gains FDA Breakthrough Therapy ... The FDA has granted GSK5764227 a breakthrough therapy designation for the treatment of extensive-stage small cell lung cancer.

5. cancernetwork.com cancernetwork.com/view/fda-grants-breakthrough-therapy-designation-to-gsk-227-in-es-sclc

FDA Grants Breakthrough Therapy Designation to GSK' ... Data showed tumor shrinkage occurring in 96.2% (n = 50/52) of patients with evaluable targeted lesions. ... Additionally, tumor shrinkage of 50% ...

6. gsk.com gsk.com/media/eurle2pv/gsk227-eu-prime-press-release.pdf

GSK's B7-H3 targeted antibody-drug conjugate (GSK'227) ... This is an ongoing phase I open-label, multi-centre trial of more than 200 patients evaluating the safety, tolerability, and preliminary anti- ...

7. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/CT195/761386/Abstract-CT195-A-phase-1-dose-escalation-expansion

A phase 1 dose escalation/expansion study of GSK5764227 ... GSK'227 (also known as HS-20093) has shown acceptable safety and promising antitumor activity in Asian patients with advanced solid tumors ...