Dostarlimab + GSK5764227 for Head and Neck Cancer
(BeeHive Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new treatments for individuals with head and neck cancer that has recurred or metastasized and cannot be treated with surgery or radiation. It examines two treatment methods: one uses a drug called GSK5764227 (an experimental treatment) alone, and the other combines GSK5764227 with another drug, dostarlimab. The trial aims to understand how these treatments work and why they might stop working in some cases. It targets individuals whose cancer has either been previously treated and stopped responding to certain therapies or who have not yet received treatment for their metastatic cancer. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop taking my current medications to join the trial?
The trial requires a washout period (time without taking certain medications) of at least 5 half-lives or 28 days, whichever is shorter, before the first dose. Additionally, you cannot continue using certain medications during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that GSK5764227 is generally safe for patients with advanced solid tumors. In earlier research, patients with small cell lung cancer who took GSK5764227 experienced manageable side effects, indicating that the treatment did not cause severe or unexpected problems for most patients.
Specific safety data for the combination of GSK5764227 and dostarlimab is not yet available. However, dostarlimab is already approved for treating other types of cancer, indicating a known safety record in cancer treatments.
In summary, past studies have shown that GSK5764227 is well-tolerated. While specific data for its use with dostarlimab in head and neck cancer is limited, both treatments have demonstrated manageable safety in other contexts.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatments involving GSK5764227 and dostarlimab for head and neck cancer because they offer a new approach compared to the standard options like surgery, radiation, and chemotherapy. GSK5764227 works by a unique mechanism targeting specific pathways that might enhance the body’s immune response against cancer cells. Dostarlimab, on the other hand, is a checkpoint inhibitor that helps the immune system better recognize and attack cancer cells. The combination of these two treatments could potentially offer a more powerful and targeted way to treat head and neck cancer, sparking hope for improved outcomes.
What evidence suggests that this trial's treatments could be effective for head and neck cancer?
Research shows that GSK5764227, which participants in this trial may receive, has promising results in treating certain cancers. In an earlier study, 81.8% of patients saw their cancer either stop growing or shrink. Dostarlimab is another treatment option in this trial, used alongside GSK5764227 in one of the study arms to enhance its cancer-fighting effects. Although dostarlimab is not yet approved specifically for head and neck cancer, researchers are studying its potential benefits. Combining these treatments aims to slow tumor growth and improve outcomes for patients with head and neck cancer.13678
Who Is on the Research Team?
Lillian Siu, MD
Principal Investigator
Princess Margaret Cancer Centre
Are You a Good Fit for This Trial?
This trial is for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that can't be cured by surgery or radiation. Participants must have measurable cancer, an ECOG performance status of 0-1, and a life expectancy over 12 weeks. Cohort A includes those previously treated with immunotherapy and chemotherapy; Cohort B includes those who haven't had systemic therapy in this setting.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants in Cohort A receive GSK5764227 monotherapy every 3 weeks, while Cohort B receives a combination of GSK5764227 and dostarlimab every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may continue treatment beyond initial progression at the Study PI's judgment
What Are the Treatments Tested in This Trial?
Interventions
- Dostarlimab
- GSK5764227
Trial Overview
The BeeHive study is testing Dostarlimab and GSK5764227 on two groups of patients to understand how they respond to treatment and why some may develop resistance. It's an open-label phase II trial where about 30 patients will receive the interventions without being compared to a control group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
All participants will receive a combination of GSK5764227 (8 mg/kg IV Q3W) and dostarlimab (500 mg IV Q3W).
All participants will receive GSK5764227 monotherapy at a starting dose of 8 mg/kg intravenously every 3 week (IV Q3W) in a 21-day treatment cycle.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
GlaxoSmithKline
Industry 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
Citations
1.
onclive.com
onclive.com/view/fda-grants-btd-to-gsk5764227-for-extensive-stage-small-cell-lung-cancerFDA Grants BTD to GSK5764227 for Extensive-Stage ...
The disease control rate (DCR) was 81.8% (95% CI, 48.2%-97.7%). Moreover, the median progression-free survival (PFS) was 4.7 months (95% CI, 1.4 ...
GSK's B7-H3-targeted antibody-drug conjugate, ...
HS-20093 is being developed by Hansoh Pharma for the treatment of lung cancer, sarcoma, head and neck cancers and other solid tumours in ...
GSK5764227 (HS-20093): A Novel B7-H3 Targeted ...
Elevated B7-H3 expression has been associated with tumor progression, immune evasion, metastasis, and poor clinical outcomes in several tumor ...
A Comprehensive Multiomic Biomarker Evaluation Across ...
PK analyses assess drug exposure for GSK5764227 (monotherapy and with dostarlimab) and relate it to PD biomarkers, clinical efficacy (ORR, PFS, ...
5.
cancernetwork.com
cancernetwork.com/view/novel-drug-receives-fda-breakthrough-therapy-designation-for-r-r-osteosarcomaNovel Drug Receives FDA Breakthrough Therapy ...
GSK5764227 yielded promising antitumor efficacy while showing no new safety signals in patients with relapsed/refractory osteosarcoma, ...
GSK's B7-H3-targeted antibody-drug conjugate, ...
The ODD was supported by preliminary clinical data showing durable responses in patients with extensive stage SCLC (ES-SCLC) who were treated ...
risvutatug rezetecan (GSK5764227) News
HS-20093 demonstrated promising antitumor activity and manageable safety in pts with previously-treated SCLC. Phase 3 study is planned to compare the efficacy ...
A phase 1b/2, multicenter, open-label study to evaluate ...
GSK'227 has shown acceptable safety and promising antitumor activity in an Asian patient (pt) population with advanced solid tumors (NCT05276609 ...
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