A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
Biohaven Therapeutics Ltd.
Study ID
NCT06384807
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Solid Tumor

Eligibility Criteria

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

Interventions

  • BHV-1510 — DRUG
    BHV-1510 will be administered on Day 1 every 3 weeks
  • Cemiplimab — DRUG
    cemiplimab (350mg) will be administered as an IV infusion on Day 1 every 3 weeks
  • BHV-1510 — DRUG
    BHV-1510 will be administered on Day 1 every 2 weeks
  • BHV-1510 — DRUG
    BHV-1510 will be administered on Day 1 and Day 8 every 3 weeks
  • Cemiplimab — DRUG
    cemiplimab (350mg) will be administered as an IV infusion on Day 1 and Day 8 every 3 weeks

Study Details

This is a Phase 1/2, first in human (FIH), open-label, multicenter study of BHV-1510 monotherapy and in Combination with Cemiplimab in participants with previously treated, advanced solid tumors.

Key Dates

Start date
Apr 22, 2024
Status verified
Mar 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

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

Arms

  • Experimental: BHV-1510 Monotherapy Dose Escalation
  • Experimental: BHV-1510 in combination with Cemiplimab dose escalation

Primary Outcome Measure

Phase 1: Number of patients with adverse events (AEs) [ Time Frame: Through study completion, estimated as an average of 47 months ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Site-113DuarteCalifornia91010-
Site-112La JollaCalifornia92093-
Site-111Palo AltoCalifornia94304-
Site-114Washington D.C.District of Columbia20016-
Site-103MiamiFlorida33176-
Site-105OrlandoFlorida32827-
Site-115TampaFlorida33612-
Site-110AugustaGeorgia30912-
Site-109DetroitMichigan48201-
Site-101St LouisMissouri63108-
Site-117New YorkNew York10021-
Site-116Oklahoma CityOklahoma73117-
Site-108PhiladelphiaPennsylvania19107-
Site-107NashvilleTennessee37203-
Site-104DallasTexas75231-
Site-106West Valley CityUtah84119-
Site-102FairfaxVirginia22031-

Find similar trials in Duarte, CA

By research site
Site-113· Duarte, CASite-112· La Jolla, CASite-111· Palo Alto, CASite-114· Washington D.C., DCSite-103· Miami, FLSite-105· Orlando, FL

Related Studies