First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid Tumors

Phase 1 Terminated 33 enrolled Pierre Fabre Laboratories

Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study will be to determine the Maximum Tolerated Dose (MTD) and describe dose-limiting toxicities (DLTs) of W0180 given as monotherapy and in combination with pembrolizumab (anti-PD-1).

Timeline

Start: 2020-09-08
Primary completion: 2023-12-19
Completion: 2023-12-19

Publications

Gomez-Roca C, Champiat S, Danlos FX, Castanon Alvarez E, Cassier PA, Dupuy E, Jegou D, Primard M, Petain A, Saccareau M, Gueguen-Dorbes G, Fabre C, Marabelle A, Melero I. First-in-human phase 1 dose-escalation study of W0180, an anti-VISTA monoclonal antibody, with and without pembrolizumab in patients with locally advanced or metastatic solid tumours. BMJ Oncol. 2026 Feb 17;5(1):e000854. doi: 10.1136/bmjonc-2025-000854. eCollection 2026.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	W0180	Monoclonal antibody	3.5 mg	—
Subject	W0180	Monoclonal antibody	60 mg	—
Subject	W0180	Monoclonal antibody	300 mg	—
Subject	W0180	Monoclonal antibody	600 mg	—
Background	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

Indications

No indication recorded.