GSK5733584 + Anticancer Therapies for Cancer
(BEHOLD-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, GSK5733584, both alone and in combination with other cancer medicines, to evaluate its safety and effectiveness for individuals with advanced cancers that have spread and do not respond to standard treatments. The trial focuses on individuals with advanced solid tumors, specifically endometrial or ovarian cancer, who have not benefited from other therapies. Participants ideally have a type of cancer that has not improved with usual treatments and experience conditions affecting daily life, such as cancer-related symptoms. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires that you stop taking any cytotoxic chemotherapy drugs or other anti-tumor drugs at least 30 days before starting the study drug. Additionally, you must stop using certain medications that affect liver enzymes (CYP3A4, CYP2D6) and proteins involved in drug transport (P-gp, BCRP) 14 days before starting the study drug.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that GSK5733584 is generally safe. In one study involving patients with advanced solid tumors, the treatment was mostly well-tolerated. Some participants experienced side effects, but these were usually manageable. Another study with Chinese patients who had recurring or spreading cancer found similar results, indicating the treatment's safety. These studies provide promising evidence about the treatment's safety, whether used alone or with other cancer medicines.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about GSK5733584 because it represents a novel approach to treating endometrial and ovarian cancers. Unlike traditional chemotherapy, which targets rapidly dividing cells indiscriminately, GSK5733584 is designed to work in tandem with other anticancer agents like Dostarlimab and Bevacizumab. This combination aims to enhance the immune system's ability to recognize and destroy cancer cells. By potentially improving the body's immune response to these cancers, GSK5733584 offers hope for more effective and targeted treatment options, possibly leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for advanced solid tumors?
Research has shown that GSK5733584 targets B7-H4, a protein often found in large amounts in tumors like ovarian and endometrial cancer, but not much in normal tissues. This makes it a promising target for treatment. Early studies have demonstrated positive results with GSK5733584 in patients who had already tried other treatments without success. In this trial, participants will receive GSK5733584 in various combinations. For instance, some will receive GSK5733584 with or without dostarlimab for endometrial cancer, while others will receive it with or without bevacizumab for ovarian cancer. Additionally, other combinations with anticancer therapies and either dostarlimab or bevacizumab are being explored. These combinations are being tested because they might work better together than a single drug alone. Overall, early findings suggest GSK5733584 might offer a new option for people with advanced solid tumors, especially those who haven't responded well to other treatments.23467
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors who haven't had success with standard treatments, can't handle them, or have no effective options left. They must be able to consent, expect to live at least 12 weeks, use reliable birth control methods, and provide a tissue sample of their tumor.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive GSK5733584 in combination with anti-cancer therapies to evaluate safety, tolerability, pharmacokinetics, and clinical activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GSK5733584
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
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