Clinical trial NCT05117177: New Formulation Study of Inupadenant (EOS100850) in Patients with Cancer
Official title: A Multicenter, Open-Label, Phase I Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Food-Effect of Inupadenant New Formulations in Participants with Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor, Adult
Keywords: Solid Tumor
Advanced Cancers
Phase I
Pharmacokinetics
Safety
Immunotherapy
Adenosine
Inupadenant
Lead sponsor: iTeos Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: iTeos Belgium SA
First posted: 2021-11-11
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Arm 1: sequential dose escalation Arm 2: randomized crossover Arm 3: single treatment assignment
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving inupadenant
timeFrame: During the DLT evaluation period that is cycle 1 (each cycle is 4 weeks)
measure: Incidence and severity of AEs in patients receiving inupadenant
timeFrame: Through study completion, an average of 4 months
Secondary outcomes:
measure: Plasma concentration of inupadenant vs. time profiles
timeFrame: Through study completion, an average of 4 months
measure: Maximum observed serum concentration (Cmax)
timeFrame: Through study completion, an average of 4 months
measure: Time of maximum observed concentration (Tmax)
timeFrame: Through study completion, an average of 4 months
measure: Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]
timeFrame: Through study completion, an average of 4 months
measure: Plasma concentration half-life (T-HALF)
timeFrame: Through study completion, an average of 4 months
measure: Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
timeFrame: Through study completion, an average of 4 months
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: GZA Ziekenhuizen
state: Antwerpen
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: iTeos Belgium SA
name: Iteos Clinical Trials
role: STUDY_DIRECTOR
References: