Solid Tumor, Adult
Conditions
Keywords
Solid Tumor, Advanced Cancers, Phase I, Pharmacokinetics, Safety, Immunotherapy, Adenosine, Inupadenant
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.
Interventions
DRUGInupadenant
Oral administration
Sponsors
iTeos Belgium SA
iTeos Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Arm 1: sequential dose escalation Arm 2: randomized crossover Arm 3: single treatment assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 of inupadenant vs. time profiles | 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 |
| Plasma concentration half-life (T-HALF) | 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 |
Countries
Belgium, United Kingdom
Outcome results
None listed