Trial intelligence / Profile preview

BHV-1510 in Advanced Solid Tumors

NCT06384807Phase 2

Key facts

Status: Recruiting
Start: Apr 2024
Primary completion: Feb 2028
Countries: 1
Sponsor: Biohaven Ltd.

Drugs: BHV-1510
Conditions: solid tumor

Overview

Phase 2, open-label trial of BHV-1510 in solid tumor (2 arms), sponsored by Biohaven Ltd. Primary endpoints: Adverse Events at 47 months, Recommended Doses for Expansion at 15 months and 3 more. Started Apr 2024; status: recruiting.

Design

2 arms

Study design: Non-randomizedOpen-label

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

Who it enrols

Adults with unresectable, incurable, locally advanced or metastatic epithelial-origin solid tumors refractory to standard therapies. Must have adequate organ function and ECOG PS 0-1. Excludes patients with symptomatic brain metastases, interstitial lung disease, or prior Trop-2-targeted therapy.

Endpoints

Primary

Adverse Events47 months
Recommended Doses for Expansion15 months
Maximum Tolerated Dose15 months
Objective Response Rate47 months
Duration of Response47 months

Secondary

Maximum Plasma Concentration22 days
Area Under the Concentration versus time Curve from the end of infusion to the last measurable concentration22 days
Area Under the Concentration versus time curve extrapolated to infinity22 days
Area under the concentration versus time curve over the dosing interval22 days
Elimination half-life22 days
Trough concentration22 days
Total body clearance22 days
Percent bioavailability22 days

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