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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
BHV-1530
DrugBHV-1530 will be administered as an IV infusion on Day 1 of each 21-day cycle
Treatment groups
95 Participants
are divided into 1 treatment groupGroup A: BHV-1530 MonotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-escalation and Dose-expansion Cohorts: Number of patients with AEs
Incidence and severity of treatment emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs) and serious adverse events (SAEs)
Time frame
Through study completion, estimated as an average of 48 months2
Dose-confirmation Cohorts: Recommended dose of BHV-1530 for later phase trials
Incidence and severity of adverse events (AEs) and SAEs, dose reductions during treatment, study discontinuation rates due to TEAEs, and signals of antitumor activity
Time frame
Through study completion, estimated as an average of 48 monthsSecondary outcomes
1
Dose-escalation and Dose-expansion Cohorts: Clinical Benefit Rate (CBR)
Assessed by RECIST v 1.1
Time frame
Through study completion, estimated as an average of 48 months2
Dose-escalation and Dose-expansion Cohorts: Objective Response Rate (ORR)
Assessed by RECIST v 1.1
Time frame
Through study completion, estimated as an average of 48 months3
Dose-escalation and Dose-expansion Cohorts: Disease Control Rate (DCR)
Assessed by RECIST v 1.1
Time frame
Through study completion, estimated as an average of 48 months4
Dose-escalation and Dose-expansion Cohorts: Time to Response (TTR)
Assessed by RECIST v 1.1
Time frame
Through study completion, estimated as an average of 48 monthsSponsors and contacts
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Source ClinicalTrials.gov