BHV-1530 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and effects of a new treatment called BHV-1530 for individuals with advanced or hard-to-treat solid tumors. It targets those whose cancer has not responded to standard treatments or for whom no standard treatment is available. Participants must have a confirmed diagnosis of advanced or metastatic cancer that affects daily life. The study does not require specific tumor markers before joining, making it more accessible for many patients. 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 protocol does not specify if you need to stop taking your current medications. However, you must not have had any standard cancer therapy or experimental therapy within 4 weeks before starting the trial.
Is there any evidence suggesting that BHV-1530 is likely to be safe for humans?
In this Phase 1 study, researchers are testing BHV-1530 in humans for the first time, so limited information exists about human reactions. At this early stage, the focus is on assessing safety and determining the optimal dose. Researchers closely monitor for any side effects. If BHV-1530 is well-tolerated, most participants do not experience serious side effects. However, detailed safety information remains limited due to the early phase of testing. Participants should understand that early trials prioritize safety and identifying a safe dose.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about BHV-1530 because it offers a new approach to cancer treatment. Unlike many traditional cancer therapies that often target rapidly dividing cells broadly, BHV-1530 is designed to specifically target cancer cells with a unique mechanism of action. This precision may lead to fewer side effects compared to standard treatments like chemotherapy or radiation. Additionally, BHV-1530's innovative approach could potentially work for cancers that are resistant to existing therapies, giving hope to patients with limited options.
What evidence suggests that BHV-1530 might be an effective treatment for cancer?
Research has shown that BHV-1530 might help treat cancers with changes in the FGFR3 gene or elevated levels of the FGFR3 protein, including bladder cancer. The FGFR3 protein aids cell growth, but alterations can lead to cancer. BHV-1530 targets these changes, potentially stopping or slowing tumor growth. While detailed human data remains limited, the drug's design suggests a promising treatment approach.12367
Are You a Good Fit for This Trial?
Adults over 18 with advanced solid tumors that have relapsed or are resistant to treatment can join this trial. They must be in good physical condition, not pregnant, willing to use contraception, and have no serious heart issues or infections. People with certain drug treatments or health conditions that could affect the study's results cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of BHV-1530 to determine the maximum tolerated dose
Dose Expansion
Participants receive the determined dose to further evaluate safety and efficacy
Dose Confirmation
Participants receive the recommended dose to confirm safety and efficacy for later phase trials
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BHV-1530
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biohaven Therapeutics Ltd.
Lead Sponsor