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

NCT06384807 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-03-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

BHV-1510

BHV-1510 will be administered on Day 1 every 3 weeks

DRUG

Cemiplimab

cemiplimab (350mg) will be administered as an IV infusion on Day 1 every 3 weeks

DRUG

BHV-1510

BHV-1510 will be administered on Day 1 every 2 weeks

DRUG

BHV-1510

BHV-1510 will be administered on Day 1 and Day 8 every 3 weeks

DRUG

Cemiplimab

cemiplimab (350mg) will be administered as an IV infusion on Day 1 and Day 8 every 3 weeks

Sponsors & Collaborators

  • Biohaven Therapeutics Ltd.

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Biohaven Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-22
Primary Completion
2028-02-29
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06384807 on ClinicalTrials.gov