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RecruitingPhase 1NCT06874335

A Phase 1 Study of BHV-1530 in Advanced Solid Tumors

Trial Parameters

ConditionSolid Tumor
SponsorBiohaven Therapeutics Ltd.
Study TypeINTERVENTIONAL
PhasePhase 1
Enrollment95
SexALL
Min Age18 Years
Max AgeN/A
Start Date2025-03-20
Completion2029-03
Interventions
BHV-1530

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Brief Summary

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

Inclusion Criteria: 1. Signed, written Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved informed consent 2. Age greater than or equal to 18 years 3. 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. 4. Participants must have progressed following, are intolerant of, or have no available standard-of-care therapy. 5. Patients with histologically or cytologically confirmed locally advanced/metastatic relapsed or refractory solid tumors as outlined below: * Dose-escalation and Dose-expansion (Backfill) Cohorts: * Participants with 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

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