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

Phase 1

Recruiting

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Inupadenant single treatment assignment (Part 1C)	Inupadenant	Part 1C will investigate an additional formulation of inupadenant in participants with advanced solid tumors.
Inupadenant sequential dose escalation (Part 1A)	Inupadenant	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.
Inupadenant randomized crossover (Part 1B)	Inupadenant	The effect of food on the exposure to inupadenant will be investigated in participants with advanced solid tumors.

Primary Outcome Measures

Name	Time	Method
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
Incidence and severity of AEs in patients receiving inupadenant	Through study completion, an average of 4 months	To assess safety and tolerability as measured by incidence and severity of AEs

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of inupadenant vs. time profiles	Through study completion, an average of 4 months	Determined by inspection of the concentration-time profile
Maximum observed serum concentration (Cmax)	Through study completion, an average of 4 months	Determined by inspection of the concentration-time profile
Time of maximum observed concentration (Tmax)	Through study completion, an average of 4 months	Determined by inspection of the concentration-time profile
Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]	Through study completion, an average of 4 months	Determined by inspection of the concentration-time profile
Plasma concentration half-life (T-HALF)	Through study completion, an average of 4 months	Determined by inspection of the concentration-time profile
Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1	Through study completion, an average of 4 months	Assessment of preliminary efficacy of inupadenant

Locations (5): GZA Ziekenhuizen
🇧🇪
Wilrijk, Antwerpen, Belgium
Institut Jules Bordet
🇧🇪
Anderlecht, Belgium
Cliniques Universitaires St-Luc
🇧🇪
Brussels, Belgium
University Hospital Ghent
🇧🇪
Ghent, Belgium
Royal Marsden NHS Foundation Trust
🇬🇧
Sutton, Surrey, United Kingdom