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Brief Title: A Study to Investigate the Safety and Tolerability of Intravenous QEQ278 in Patients With Advanced Solid Tumors
Official Title: A Phase I/Ib, Open-label, Multi-center, Study of QEQ278 in Patients With Advanced Solid Tumors
Study ID: NCT05462873
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Of California LA Santa Monica Location, Los Angeles, California, United States
Florida Cancer Specialists Sarasota Office, Fort Myers, Florida, United States
Massachusetts General Hospital Dept. of Mass General Hospital, Boston, Massachusetts, United States
Novartis Investigative Site, Bruxelles, , Belgium
Novartis Investigative Site, Paris, , France
Novartis Investigative Site, Essen, , Germany
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Kashiwa, Chiba, Japan
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Taipei, , Taiwan