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

Part of paid clinical trials in Newport Beach, California.

Sponsor
Biohaven Therapeutics Ltd.
Study ID
NCT06874335
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BHV-1530 — DRUG
    BHV-1530 will be administered as an IV infusion on Day 1 of each 21-day cycle
  • Cemiplimab — DRUG
    cemiplimab (350 mg) will be administered as an IV infusion on Day 1 of each 21-day cycle

Study Details

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

Key Dates

First listed
Mar 13, 2025
Start date
Mar 20, 2025
Status verified
Jul 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: BHV-1530 Monotherapy
  • Experimental: Experimental: BHV-1530 in combination with Cemiplimab

Primary Outcome Measure

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 [ Time Frame: Through study completion, estimated as an average of 48 months ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Site-111Newport BeachCalifornia92663-
Site-107DenverColorado80218-
Site-108Lake MaryFlorida32746-
Site-121MiamiFlorida33136-
Site-118OrlandoFlorida32804-
Site-120Ann ArborMichigan48109-
Site-110DetroitMichigan48201-
Site-115DurhamNorth Carolina27710-
Site-122ClevelandOhio44195-
Site-112Myrtle BeachSouth Carolina29572-
Site-116NashvilleTennessee37203-
Site-103AustinTexas78758-
Site-104HoustonTexas77030-
Site-101IrvingTexas75039-
Site-105San AntonioTexas78229-
Site-106West Valley CityUtah84119-
Site-102FairfaxVirginia22031-

Find similar trials in Newport Beach, CA

By research site
Site-111· Newport Beach, CASite-107· Denver, COSite-108· Lake Mary, FLSite-121· Miami, FLSite-118· Orlando, FLSite-120· Ann Arbor, MI

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