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

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

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

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Drug: Inupadenant

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Medical Director, MD; Phone Number: +32 71 91 99 33; Email: clinical_info@iteostherapeutics.com

Study Locations

• Belgium
  • Antwerpen, Belgium
    • Recruiting
    • GZA Ziekenhuizen
    • Contact: Tom Van der Mooter, MD PhD
  • Brussels, Belgium, 1000
    • Recruiting
    • Institut Jules Bordet
    • Contact: Laurence Buisseret, MD, PhD
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires St-Luc
    • Contact: Jean-Pierre Machiels, MD, PhD
  • Ghent, Belgium, 9000
    • Recruiting
    • University Hospital Ghent
    • Contact: Sylvie Rottey, MD, PhD
• United Kingdom
  • London, United Kingdom, SW3 6JJ
    • Recruiting
    • Royal Marsden NHS Foundation Trust
    • Contact: Johan DeBono, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving inupadenant	Incidence of adverse events (AEs), serious adverse events (SAEs), DLTs, AEs leading to discontinuation, deaths, electrocardiogram (ECG) abnormalities, and clinically significant laboratory abnormalities	During the DLT evaluation period that is cycle 1 (each cycle is 4 weeks)
Incidence and severity of AEs in patients receiving inupadenant	To assess safety and tolerability as measured by incidence and severity of AEs	Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration of inupadenant vs. time profiles	Determined by inspection of the concentration-time profile	Up to 11 months
Maximum observed serum concentration (Cmax)	Determined by inspection of the concentration-time profile	Up to 11 months
Time of maximum observed concentration (Tmax)	Determined by inspection of the concentration-time profile	Up to 11 months
Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]	Determined by inspection of the concentration-time profile	Up to 11 months
Plasma concentration half-life (T-HALF)	Determined by inspection of the concentration-time profile	Up to 11 months
Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1	Assessment of preliminary efficacy of inupadenant	Through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: iTeos Therapeutics
• Investigators: Principal Investigator: Jean-Pierre Machiels, MD, PhD, Cliniques Universitaires San Luc

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: A2A-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No