First-in-Human Study of EOS100850 (Inupadenant) in Patients with Cancer

Completed · Phase 1

Conditions studied: Solid Tumor, Adult

In brief

Multicenter, open-label, dose-escalation Phase I/Ib clinical study to evaluate the safety and tolerability, the MTD/RP2D, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of EOS100850 (Inupadenant) as a Single Agent and in Combination with Pembrolizumab and/or Chemotherapy in Participants with Advanced Cancers.

Key facts

Study ID

NCT03873883

Run by

iTeos Therapeutics

People needed

119

Starts

2019-02-05

Expected to finish

2024-05-28

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Women and men ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Subject with histologically or cytologically confirmed advanced solid tumor for whom no standard treatment is further available.
• At least 4 weeks since any previous treatment for cancer
• Subject must consent to pretreatment and on treatment tumor biopsies
• Adequate organ and marrow function

You may not qualify if…

• Patients with primary brain tumors or primary tumors with central nervous system metastases as only location of disease. Controlled brain metastases are permitted
• Participants with second/other active cancers requiring current treatment
• Uncontrolled/significant heart disease
• Known History of chronic hepatitis, Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except participants with liver cancer) or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS)
• Active/uncontrolled autoimmune disease
• Active infection
• Other protocol defined inclusion/exclusion criteria could apply

Where it is running

• Karmanos Cancer Institute — Michigan Center, Michigan, United States
• John Theurer Cancer Center, Hackensack University Medical Center — Hackensack, New Jersey, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• Hospital GZA Sint-Augustinus — Wilrijk, Antwerpen, Belgium
• Institut Jules Bordet — Anderlecht, Brussels Capital, Belgium
• UCL Saint-Luc — Brussels, Brussels Capital, Belgium
• UZ Ghent — Ghent, East-Flanders, Belgium
• Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard — Lyon, France
• Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie- Pôle Régional de Cancérologie — Poitiers, France
• Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau — Saint-Herblain, France
• Gustave Roussy — Villejuif, France
• Yonsei University Severance Hospital — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea
• St Mary's Hospital, The Catholic University of Korea — Seoul, South Korea
• Hospital del Mar — Barcelona, Spain
• START Madrid-HM CIOCC Hospital Universitario HM Sanchinarro — Madrid, Spain
• Universidad de Navarra - Clinica Universitaria de Navarra — Pamplona, Spain
• Onkologikoa — San Sebastián, Spain
• The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital — Sutton, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.