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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005861-15 | EudraCT Number |
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| Name | Class |
|---|---|
| iTeos Belgium SA | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inupadenant sequential dose escalation (Part 1A) | Experimental | 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. |
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| Inupadenant randomized crossover (Part 1B) | Experimental | The effect of food on the exposure to inupadenant will be investigated in participants with advanced solid tumors. |
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| Inupadenant single treatment assignment (Part 1C) | Experimental | Part 1C will investigate an additional formulation of inupadenant in participants with advanced solid tumors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inupadenant | Drug | Oral administration |
|
| 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 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of inupadenant vs. time profiles | Determined by inspection of the concentration-time profile | Through study completion, an average of 4 months |
| Maximum observed serum concentration (Cmax) |
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For more information regarding participation in the Trial, please refer to your physician
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iteos Clinical Trials | iTeos Belgium SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GZA Ziekenhuizen | Wilrijk | Antwerpen | 2610 | Belgium | ||
| Cliniques Universitaires St-Luc |
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Arm 1: sequential dose escalation Arm 2: randomized crossover Arm 3: single treatment assignment
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| Inupadenant | Drug | Oral administration |
|
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| Inupadenant | Drug | Oral administration |
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Determined by inspection of the concentration-time profile
| Through study completion, an average of 4 months |
| Time of maximum observed concentration (Tmax) | Determined by inspection of the concentration-time profile | Through study completion, an average of 4 months |
| Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] | Determined by inspection of the concentration-time profile | Through study completion, an average of 4 months |
| Plasma concentration half-life (T-HALF) | Determined by inspection of the concentration-time profile | Through study completion, an average of 4 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 4 months |
| Brussels |
| Brussels Capital |
| 1200 |
| Belgium |
| University Hospital Ghent | Ghent | Ghent | 9000 | Belgium |
| Institut Jules Bordet | Anderlecht | 1070 | Belgium |
| Royal Marsden NHS Foundation Trust | Sutton | Surrey | SM2 5PT | United Kingdom |