New Formulation Study of Inupadenant (EOS100850) in Patients with Cancer

Last updated: September 5, 2024
Sponsor: iTeos Therapeutics
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Inupadenant

Clinical Study ID

NCT05117177
A2A-004
2020-005861-15
  • Ages > 18
  • All Genders

Study Summary

A2A-004 is a three-part multicenter, open-label, Phase I clinical trial intended to evaluate the safety and tolerability, and the pharmacokinetics (PK) and food effect of new formulations of inupadenant (formerly known as EOS100850), in participants with advanced solid tumors.

Eligibility Criteria

Inclusion

For more information regarding participation in the Trial, please refer to your physician

Inclusion Criteria:

  • 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 whomno 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

Exclusion

Exclusion Criteria:

  • Patients with primary brain tumors or primary tumors with central nervous systemmetastases 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 surfaceantigen or - - Hepatitis C antibody (except participants with liver cancer) or HumanImmunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS)

  • Active/uncontrolled autoimmune disease

  • Active infection

  • Other protocol defined inclusion/exclusion criteria could apply

Study Design

Total Participants: 57
Treatment Group(s): 1
Primary Treatment: Inupadenant
Phase: 1
Study Start date:
July 01, 2021
Estimated Completion Date:
May 09, 2024

Connect with a study center

  • GZA Ziekenhuizen

    Wilrijk, Antwerpen 2610
    Belgium

    Site Not Available

  • Institut Jules Bordet

    Anderlecht, 1070
    Belgium

    Site Not Available

  • GZA Ziekenhuizen

    Antwerpen,
    Belgium

    Site Not Available

  • Cliniques Universitaires St-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Institut Jules Bordet

    Brussels, 1000
    Belgium

    Active - Recruiting

  • University Hospital Ghent

    Ghent, 9000
    Belgium

    Site Not Available

  • Royal Marsden NHS Foundation Trust

    Sutton, Surrey SM2 5PT
    United Kingdom

    Site Not Available

  • Royal Marsden NHS Foundation Trust

    London, SW3 6JJ
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.