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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503844-14-00 | EU Trial (CTIS) Number |
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APT-008 is an open-label, Phase I/Ib, dose escalation and expansion cohort study to evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and preliminary efficacy of EOS301984 as monotherapy and in combination with other anticancer therapies in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A dose escalation | Experimental | EOS301984 dose escalation as monotherapy |
|
| Part 1B dose escalation | Experimental | EOS301984 in combination with other cancer therapies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EOS301984 | Drug | Multiple doses of EOS301984 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the safety and tolerability of EOS301984 alone and in combination with other anticancer agents in participants with advanced solid tumors | From first study treatment administration to last participant last follow-up (Up to 4 years) | |
| Incidence and severity of AEs in patients receiving EEOS301984 | From first study treatment administration to last participant last follow-up (Up to 4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean and median Area under the curve (AUC) of EOS301984 following first dose and repeated administration at each dose level | From first dose up to 21 days repeated cycles | |
| Mean and median Maximum concentration (Cmax) of EOS301984 following first dose and repeated administration at each dose level |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Iteos Clinical Trials | iTeos Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Brussels | 1070 | Belgium | |||
| Cliniques Universitaires Saint-Luc |
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| Anti-PD-1 monoclonal antibody | Drug | Multiple doses of EOS301984 in combination with Anti-PD-1 |
|
| From first dose up to 21 days repeated cycles |
| Define the recommended Phase 2 dose (RP2D) in participants with advanced tumors. | From first study treatment administration to last participant last follow-up (Up to 4 years) |
| Percentage of participants with Objective Response as determined by Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | From first study treatment administration to last participant last follow-up (Up to 4 years) |
| Brussels |
| 1200 |
| Belgium |
| Grand Hopital de Charleroi | Charleroi | 6060 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| CHU de Liège | Liège | 4000 | Belgium |
| GZA Ziekenhuizen campus Sint-Augustinus | Wilrijk | 2610 | Belgium |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
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