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

iTeos Therapeutics57 enrolled

Overview

A2A-004 is a three-part multicenter, open-label, Phase I clinical trial intended to evaluate the safety and tolerability, and the pharmacokinetics (PK) and food effect of new formulations of inupadenant (formerly known as EOS100850), in participants with advanced solid tumors.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumor, Adult

Interventions

InupadenantDRUG

Oral administration

InupadenantDRUG

Oral administration

InupadenantDRUG

Oral administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

GZA Ziekenhuizen

Wilrijk, Antwerpen, Belgium

Cliniques Universitaires St-Luc

Brussels, Brussels Capital, Belgium

University Hospital Ghent

Ghent, Ghent, Belgium

Institut Jules Bordet

Anderlecht, Belgium

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Through study completion, an average of 4 months