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Completed

NCT Number: NCT03873883

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

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.

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Key information

Conditions

Solid Tumor, Adult Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital GZA Sint-Augustinus, Wilrijk, Antwerpen, Belgium

Loading trial locations.

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

EOS100850

Drug

Oral administration

Other names: Inupadenant

Pembrolizumab

Drug

IV Infusion

Other names: Keytruda, MK-3475

Chemotherapy

Drug

Standard of Care IV Infusion

Other names: carboplatin and paclitaxel

Primary outcomes

  1. Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving EOS100850

    Time frame: During the DLT evaluation period that is cycle 1 (each cycle is 3 or 4 weeks)

    To define the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) of EOS100850 in patients receiving EOS100850

  2. Incidence and severity of AEs in patients receiving EOS100850

    Time frame: Up to 30 months

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

Secondary outcomes

  1. Plasma concentration of EOS100850 vs. time profiles

    Time frame: Up to 30 months

    Determined by inspection of the concentration-time profile

  2. Maximum observed serum concentration (Cmax)

    Time frame: Up to 30 months

    Determined by inspection of the concentration-time profile

  3. Time of maximum observed concentration (Tmax)

    Time frame: Up to 30 months

    Determined by inspection of the concentration-time profile

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

    Time frame: Up to 30 months

    Determined by inspection of the concentration-time profile

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

    Time frame: Up to 30 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: Up to 30 months

    Assessment of preliminary efficacy of EOS100850

Sponsors and collaborators

Lead sponsor

iTeos Therapeutics

Industry

Collaborators

  • Merck Sharp & Dohme LLC
  • iTeos Belgium SA

Registry information

Official study title

Phase I/Ib First-in-Human Study of EOS100850 (Inupadenant) As a Single Agent and in Combination with Pembrolizumab And/or Chemotherapy in Participants with Advanced Cancers

Acronym: IO-001

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Mar 14, 2019
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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