NCT05577182

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

A Phase 1, Open-Label, Multicenter Study of INCA32459 in Participants With Select Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Malignancies

Interventions

Type	Name	Description
DRUG	INCA32459-101	solution for infusion

Timeline

• Start date: 2023-01-05
• Primary completion: 2025-10-13
• Completion: 2025-10-13
• First posted: 2022-10-13
• Last updated: 2025-11-03

Locations

13 sites across 4 countries: United States, Belgium, Italy, Spain

Regulatory

• FDA-regulated drug study