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

Sponsor
iTeos Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05117177
Collaborator
(none)
64
Enrollment
4
Locations
2
Arms
16.6
Anticipated Duration (Months)
16
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Arm A sequential dose escalation Arm B randomized crossoverArm A sequential dose escalation Arm B randomized crossover
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label, Phase I Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Food-Effect of Inupadenant New Formulation in Participants With Advanced Solid Tumors
Actual Study Start Date :
Jul 14, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1a

Part 1A will evaluate the safety as well as to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of inupadenant in participants with advanced solid tumors.

Drug: Inupadenant
Oral administration
Other Names:
  • EOS100850

    		•
    Experimental: Part 1b

    The effect of food on the exposure to inupadenant will be investigated.

    Drug: Inupadenant
    Oral administration
    Other Names:
  • EOS100850

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving inupadenant [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 [Through study completion, an average of 3 months]

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

    Secondary Outcome Measures

    1. Plasma concentration of inupadenant vs. time profiles [Up to 11 months]

      Determined by inspection of the concentration-time profile

    2. Maximum observed serum concentration (Cmax) [Up to 11 months]

      Determined by inspection of the concentration-time profile

    3. Time of maximum observed concentration (Tmax) [Up to 11 months]

      Determined by inspection of the concentration-time profile

    4. Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] [Up to 11 months]

      Determined by inspection of the concentration-time profile

    5. Plasma concentration half-life (T-HALF) [Up to 11 months]

      Determined by inspection of the concentration-time profile

    6. Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 [Through study completion, an average of 3 months]

      Assessment of preliminary efficacy of inupadenant

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut Jules Bordet Brussels Belgium 1000
    2 Cliniques Universitaires St-Luc Brussels Belgium 1200
    3 University Hospital Ghent Ghent Belgium 9000
    4 Royal Marsden NHS Foundation Trust London United Kingdom SW3 6JJ

    Sponsors and Collaborators

    • iTeos Therapeutics

    Investigators

    • Principal Investigator: Jean-Pierre Machiels, MD, PhD, Cliniques Universitaires San Luc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    iTeos Therapeutics
    ClinicalTrials.gov Identifier:
    NCT05117177
    Other Study ID Numbers:
    • A2A-004
    First Posted:
    Nov 11, 2021
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 2, 2022