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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Solid Tumor, Adult

Intervention / Treatment
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* Drug: Inupadenant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Arm A sequential dose escalation Arm B randomized crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1a<br>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<br>* Oral administration<br>* Other names: EOS100850;|
| Experimental: Part 1b<br>The effect of food on the exposure to inupadenant will be investigated. | Drug: Inupadenant<br>* Oral administration<br>* Other names: EOS100850;|

What is the study measuring?
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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 |