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Trial record 1 of 1 for:    NCT05117177
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New Formulation Study of Inupadenant (EOS100850) in Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05117177
Recruitment Status : Recruiting
First Posted : November 11, 2021
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
iTeos Therapeutics

Study Description
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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
Solid Tumor, Adult Drug: Inupadenant Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Arm 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 : July 14, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : November 2023
Arms and Interventions
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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 Name: EOS100850
Experimental: Part 1b
The effect of food on the exposure to inupadenant will be investigated.
 Drug: Inupadenant
Oral administration
Other Name: EOS100850


Outcome Measures
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Primary Outcome Measures :
  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 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 [ Time Frame: Up to 11 months ]
    Determined by inspection of the concentration-time profile

  2. Maximum observed serum concentration (Cmax) [ Time Frame: Up to 11 months ]
    Determined by inspection of the concentration-time profile

  3. Time of maximum observed concentration (Tmax) [ Time Frame: 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)] [ Time Frame: Up to 11 months ]
    Determined by inspection of the concentration-time profile

  5. Plasma concentration half-life (T-HALF) [ Time Frame: 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 [ Time Frame: Through study completion, an average of 3 months ]
    Assessment of preliminary efficacy of inupadenant


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05117177


Contacts
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Contact: Medical Director, MD +32 71 91 99 33 clinical_info@iteostherapeutics.com

Locations
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Belgium
GZA Ziekenhuizen Recruiting
Antwerpen, Belgium
Contact: Tom Van der Mooter, MD PhD         
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Laurence Buisseret, MD, PhD         
Cliniques Universitaires St-Luc Recruiting
Brussels, Belgium, 1200
Contact: Jean-Pierre Machiels, MD, PhD         
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Sylvie Rottey, MD, PhD         
United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6JJ
Contact: Johan DeBono, MD, PhD         
Sponsors and Collaborators
iTeos Therapeutics
Investigators
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Principal Investigator: Jean-Pierre Machiels, MD, PhD Cliniques Universitaires San Luc
More Information
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Responsible Party: iTeos Therapeutics
ClinicalTrials.gov Identifier: NCT05117177    
Other Study ID Numbers: A2A-004
First Posted: November 11, 2021    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No