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Completed

NCT Number: NCT05117177

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

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.

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Key information

Conditions

Solid Tumor, Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GZA Ziekenhuizen, Wilrijk, Antwerpen, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Exclusion criteria

  • 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

Treatment and study plan

Inupadenant

Drug

Oral administration

Other names: EOS100850

Primary outcomes

  1. Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving inupadenant

    Time frame: During the DLT evaluation period that is cycle 1 (each cycle is 4 weeks)

    Incidence of adverse events (AEs), serious adverse events (SAEs), DLTs, AEs leading to discontinuation, deaths, electrocardiogram (ECG) abnormalities, and clinically significant laboratory abnormalities

  2. Incidence and severity of AEs in patients receiving inupadenant

    Time frame: Through study completion, an average of 4 months

    To assess safety and tolerability as measured by incidence and severity of AEs

Secondary outcomes

  1. Plasma concentration of inupadenant vs. time profiles

    Time frame: Through study completion, an average of 4 months

    Determined by inspection of the concentration-time profile

  2. Maximum observed serum concentration (Cmax)

    Time frame: Through study completion, an average of 4 months

    Determined by inspection of the concentration-time profile

  3. Time of maximum observed concentration (Tmax)

    Time frame: Through study completion, an average of 4 months

    Determined by inspection of the concentration-time profile

  4. Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]

    Time frame: Through study completion, an average of 4 months

    Determined by inspection of the concentration-time profile

  5. Plasma concentration half-life (T-HALF)

    Time frame: Through study completion, an average of 4 months

    Determined by inspection of the concentration-time profile

  6. Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1

    Time frame: Through study completion, an average of 4 months

    Assessment of preliminary efficacy of inupadenant

Sponsors and collaborators

Lead sponsor

iTeos Therapeutics

Industry

Collaborators

  • iTeos Belgium SA

Registry information

Official study title

A Multicenter, Open-Label, Phase I Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Food-Effect of Inupadenant New Formulations in Participants with Advanced Solid Tumors

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 11, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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