A Phase 1 Study of BHV-1530 in Advanced Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiohaven Therapeutics Ltd.
About this trial
This is a Phase 1, first in human (FIH), open-label, multicenter study of BHV-1530 in adult participants with advanced or metastatic solid tumors.
Eligibility criteria
Qualifiers
Signed, written Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved informed consent
Age greater than or equal to 18 years
Participants consent to provide tumor tissue collected prior to study treatment, preferably from a biopsy performed after their last anticancer therapy and within 90 days of the start of study treatment. An older archival sample may be acceptable with Sponsor approval.
Participants must have progressed following, are intolerant of, or have no available standard-of-care therapy.
Disqualifiers
Prior treatment with antibody drug conjugate (ADC) with a topoisomerase-I inhibitor payload. Prior direct treatment with topoisomerase inhibitor (e.g., irinotecan, topotecan, belotecan, nano-liposomal irinotecan) are not exclusionary.
New York Heart Association Class III or IV heart failure
Myocardial infarction, unstable angina, or stroke ≤ 6 months prior to C1D1
Newly diagnosed thromboembolic events that require therapeutic intervention over the last 6 months prior to C1D1 (participants with stable control of lower limb deep venous thrombosis over at least 3 months are allowed)
Trial design
Treatments tested in this trial
- BHV-1530
Treatment groups
95 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov