GSK5764227 for Advanced Cancer

Recruiting at 21 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

281 Participants Needed

Trial Summary

What is the purpose of this trial?

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 of GSK5764227 will change over time at different dose amounts when administered alone and in combination with other medicines like carboplatin, cisplatin, atezolizumab, pembrolizumab, durvalumab, bevacizumab, cetuximab.

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.

Eligibility Criteria

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 a life expectancy >12 weeks

I am 18 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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

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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