NCT05462873

A Study to Investigate the Safety and Tolerability of Intravenous QEQ278 in Patients With Advanced Solid Tumors

A Phase I/Ib, Open-label, Multi-center, Study of QEQ278 in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human papilloma virus associated head and neck squamous cell carcinoma.

Detailed description

This study is an open-label, phase I/Ib, multi-center study of QEQ278 as a single agent, consisting of a dose escalation part followed by a dose expansion part. In the dose escalation part of the study, patients with non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), renal cell carcinoma (RCC), or human papilloma virus (HPV)-associated head and neck squamous cell carcinoma (HNSCC) will be treated with QEQ278 single agent until the maximum tolerated dose (MTD) is reached or a lower recommended dose (RD) is established. The study may enter the dose expansion, after an MTD(s) and/or RD(s) is declared in the dose escalation.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Renal Cell
• Esophageal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
BIOLOGICAL	QEQ278	Intravenous dosing of QEQ278

Timeline

• Start date: 2023-04-04
• Primary completion: 2026-01-26
• Completion: 2026-01-26
• First posted: 2022-07-18
• Last updated: 2026-02-17

Locations

12 sites across 9 countries: United States, Belgium, France, Germany, Italy, Japan, Singapore, Spain, Taiwan

Regulatory

• FDA-regulated drug study