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, Dose Escalation, Dose Expansion and Dose Optimization Study of BHV-1530 as Monotherapy and in Combination with Other Anti-Cancer Agents 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 4 months prior to C1D1 (participants with stable control of lower limb deep venous thrombosis over at least 1 months are allowed, and participants with incidental, asymptomatic pulmonary embolism and clinically stable for at least 1 month prior to C1D1 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
Cemiplimab
Drugcemiplimab (350 mg) will be administered as an IV infusion on Day 1 of each 21-day cycle
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: BHV-1530 MonotherapyExperimental treatment 1 intervention
Group B: Experimental: BHV-1530 in combination with CemiplimabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Dose-escalation and Dose-expansion Cohorts: To determine the safety profile, maximum tolerable dose (MTD), minimally reproducible active dose (MRAD), and recommended dose range (RDR) of BHV-1530 monotherapy and BHV-1530 in combination with cemiplimab
Incidence and severity of TEAEs, including DLTs, SAEs and change from baseline for laboratory values, electrocardiograms (ECGs), vital signs, and physical exams to determine the safety profile, MTD, MRAD and RDR of BHV-1530 monotherapy and in combination with cemiplimab.
Time frame
Through study completion, estimated as an average of 48 months2
Dose-optimization Cohorts: Recommended dose of BHV-1530 for later phase trials
Incidence and severity of treatment-emergent AEs and SAEs, changes between baseline and postbaseline in laboratory values, ECGs, vital signs, and physical exams.
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