GSK5733584 for Cancer

(BEHOLD-1 Trial)

Recruiting at 28 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Must not be taking: Cytotoxic chemotherapy, Anti-tumor drugs

Disqualifiers: Brain metastasis, Cardiovascular disorders, ILD, others

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

Compensation: Varies

Number of Visits: Unknown

240 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to assess the safety and tolerability of GSK5733584. The study will also see how the levels of GSK5733584 change over time at different dose amount.

Will I have to stop taking my current medications?

The trial requires that you stop taking any cytotoxic chemotherapy drugs, anti-tumor traditional Chinese medicines, or other anti-tumor drugs at least 28 days before starting the study drug. If you need to continue these medications, you cannot participate in the trial.

Eligibility Criteria

Adults with advanced solid tumors who've failed or can't tolerate standard treatments, have a life expectancy of at least 12 weeks, and are generally in stable condition (ECOG PS score of 0-2). They must have measurable cancer and provide tissue samples for biomarker analysis. Excluded are those with poor marrow or organ function, heart issues, certain ECG abnormalities, recent major surgeries or therapies.

Inclusion Criteria

Have a life expectancy of at least 12 weeks

My physical health has been stable for the last 2 weeks.

Participants have at least one target lesion as assessed per the RECIST 1.1

Exclusion Criteria

My bone marrow, liver, or kidney functions are not normal.

I have received treatments targeting B7-H4.

I have a history of heart rhythm problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants with advanced solid tumors receive escalating doses of GSK5733584 to assess safety and tolerability

Up to approximately 31 months

Dose Expansion

Participants with platinum-resistant ovarian cancer and endometrial cancer receive GSK5733584 to further evaluate safety and clinical activity

Up to approximately 28 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• GSK5733584

Trial Overview The trial is testing GSK5733584's safety and how the body processes it at different doses in people with advanced solid tumors. It will involve regular monitoring to determine the appropriate dosage levels and observe any clinical response to the treatment.

Participant Groups

Group I: Part 2: Dose Expansion Experimental Treatment 1 Intervention

Participants with platinum-resistant ovarian cancer (PROC) and endometrial cancer (EC)

Group II: Part 1: Dose Escalation Experimental Treatment 1 Intervention

Participants with advanced solid tumors who are refractory or intolerant to established standard therapies

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