BGB-B455 for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called BGB-B455 to determine its effectiveness for people with advanced solid tumors that cannot be surgically removed and express a specific protein, claudin 6. Researchers aim to find the optimal dose and identify any potential side effects. The trial consists of two stages: one to determine the right dose and another to test this dose further. Suitable participants have solid tumors that have not responded to other treatments and express the claudin 6 protein. As a Phase 1 trial, the research focuses on understanding 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 prior systemic anticancer therapy, including chemotherapy, immunotherapy, and targeted therapy, at least 14 days or 5 half-lives before starting the study drug. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
Is there any evidence suggesting that BGB-B455 is likely to be safe for humans?
Research has shown that BGB-B455 is in the early testing stages for treating solid tumors with a protein called claudin 6. As a Phase 1 study, researchers focus primarily on the treatment's safety and determining the optimal dose.
At this stage, small groups test the treatment to assess its safety, monitor side effects, and evaluate patient tolerance. Detailed safety results may not yet be available due to the study's early phase. However, as a Phase 1 trial, the drug is being tested in humans for the first time, and safety information is still being gathered.
Joining a Phase 1 trial involves some uncertainty about potential risks and benefits. Prospective participants should discuss with the trial team to understand possible side effects and the safety measures in place during the study.12345Why do researchers think this study treatment might be promising?
BGB-B455 is unique because it targets specific proteins involved in the growth of solid tumors, which might make it more effective than traditional chemotherapy that attacks all rapidly dividing cells. Researchers are excited about its potential to be used both on its own and in combination with other treatments, possibly leading to more personalized and flexible therapy options. Additionally, the innovative approach in dose expansion could help optimize its effectiveness and safety for different types of solid tumors, offering new hope for patients with these challenging cancers.
What evidence suggests that BGB-B455 might be an effective treatment for solid tumors?
Research has shown that BGB-B455 targets solid tumors with a protein called claudin 6 (CLDN6), found on some cancer cells. BGB-B455 is designed to attack these cells. Early studies suggest that this treatment might help shrink tumors by focusing on these specific cancer markers. The trial will evaluate BGB-B455 both as a monotherapy and in combination with investigator-selected chemotherapy. Initial findings indicate that patients can tolerate BGB-B455, whether used alone or with chemotherapy. While more research is needed to confirm its effectiveness, these early results are promising for treating these types of tumors.15678
Who Is on the Research Team?
Study Director
Principal Investigator
BeiGene
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic solid tumors that have a protein called CLDN6. Participants must have at least one measurable tumor, be in stable condition (ECOG 0 or 1), and have good organ function. They should also agree to provide tissue samples for testing. It's not for those who haven't tried standard treatments unless they couldn't tolerate them.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1a: Dose Escalation and Safety Expansion
Sequential cohorts of increasing dose levels of BGB-B455 will be evaluated as monotherapy, followed by a safety expansion at selected doses
Phase 1b: Dose Expansion
Participants will be enrolled at the best dose found in Phase 1a to evaluate efficacy in selected indications
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BGB-B455
Find a Clinic Near You
Who Is Running the Clinical Trial?
BeiGene
Lead Sponsor