Advanced or Metastatic Tumors Study
If you or a loved one has been diagnosed with Advanced or Metastatic Solid Tumors, a clinical trial may be able to help.
Who’s Included?
Adults; All genders
18–95
Drug & Formulation
BHVN-1530
IV Infusion
Possibility of Placebo
What are Advanced or Metastatic Tumors?
Advanced or metastatic tumors are cancers that have spread beyond their original site. “Advanced” usually means the tumor has grown large or invaded nearby tissues, while “metastatic” means cancer cells have traveled through the bloodstream or lymph system to form new tumors in other parts of the body. At this stage, the disease is often harder to treat, and therapy typically focuses on slowing growth, managing symptoms, and improving quality of life.
What is the Purpose of This Clinical Trial?
The two major purposes of this clinical trial are to determine the maximum dose of BHV-1530 that can be safely taken, and once this dose is found, if it has any effect against the cancer in participants with certain types of cancers.
- Be ≥ 18 years of age
- Provide tumor tissue collected prior to study treatment
- Have urothelial cancer of the urinary tract: (including renal pelvis, ureters, urinary bladder, and urethra), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) regardless of the presence of an activating FGFR3 alteration (mutation, fusion, or amplification) or high FGFR3 protein or mRNA expression in the absence of a detectable genetic alteration.
- Have other advanced or metastatic solid tumors with a documented activating FGFR3 alteration (mutation, fusion, or amplification) or high FGFR3 protein or mRNA expression in the absence of a detectable genetic alteration.
- Have progressed following, are intolerant of, or have no available standard-of-care therapy
- Have measurable disease and ECOG status of 0 or 1
- Have acceptable lab values as per the inclusion/exclusion criteria of the protocol
- Have had prior treatment with antibody drug conjugate (ADC)
- Have any clinically significant intercurrent disease
- Have had any standard cancer therapy or experimental therapy within 4 weeks of starting the trial
- Have any clinically significant corneal or retinal abnormality that may increase the risk of eye toxicity
- Have any active infections
Frequently Asked Questions
About 95 people will participate in this study.
This study is being conducted on behalf of Biohaven by multiple sites (clinics or hospitals) across the United States with trained and qualified medical specialists.
No. If you qualify and are chosen to participate, you will receive all study-related care at no cost to you.
Your participation is fully voluntary. You may leave the study at any time.
Visit ClinicalTrials.gov and find a clinic near you.