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

Solid Tumor, Adult Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05117177
• Other study ID #: A2A-004
• Status: Recruiting
• Phase: Phase 1
• Start date: July 14, 2021
• Est. completion date: November 2023

Study information

• Verified date: May 2023
• Source: iTeos Therapeutics
• Contact: Medical Director, MD
• Phone: +32 71 91 99 33
• Email: clinical_info[@]iteostherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: November 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumor, Adult

Intervention

Drug:
• Inupadenant
Oral administration

Locations

Country	Name	City	State
Belgium	GZA Ziekenhuizen	Antwerpen
Belgium	Cliniques Universitaires St-Luc	Brussels
Belgium	Institut Jules Bordet	Brussels
Belgium	University Hospital Ghent	Ghent
United Kingdom	Royal Marsden NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
iTeos Therapeutics

Countries where clinical trial is conducted

Belgium,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Plasma concentration of inupadenant vs. time profiles	Determined by inspection of the concentration-time profile	Up to 11 months
Secondary	Maximum observed serum concentration (Cmax)	Determined by inspection of the concentration-time profile	Up to 11 months
Secondary	Time of maximum observed concentration (Tmax)	Determined by inspection of the concentration-time profile	Up to 11 months
Secondary	Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]	Determined by inspection of the concentration-time profile	Up to 11 months
Secondary	Plasma concentration half-life (T-HALF)	Determined by inspection of the concentration-time profile	Up to 11 months
Secondary	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