drugset / Trial / NCT05577182

Study of INCA32459 a LAG-3 and PD-1 Bispecific Antibody in Participants With Select Advanced Malignancies

NCT05577182 ↗

Phase 1 Completed 46 enrolled Incyte Corporation
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a multicenter, open-label, single-arm study to investigate the safety, tolerability, PK, pharmacodynamics and preliminary activity of INCA32459 in participants with selected advanced malignancies. Part 1 (dose escalation) will determine the recommended dose of INCA 32459 for expansion (RDE) and the maximum tolerated dose (MTD). Part 2 (dose expansion) will further evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of INCA 32459 at the recommended dose(s) for expansion in 2 tumor-specific cohorts.

Timeline

Start
2023-01-05
Primary completion
2025-10-13
Completion
2025-10-13

Drugs

EvaluationDrugModalityDoseRoute
Subject INCA32459 Unknown — Intravenous

Indications