Advanced solid tumors
Conditions
Brief summary
Part 1 – Dose Finding: Incidence and frequency of adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), AEs leading to discontinuation, deaths, vital signs, electrocardiogram (ECG) abnormalities, LVEF, and clinically significant laboratory abnormalities., Part 2 – Expansion: Overall Response Rate (ORR) will be defined according to RECIST v1.1., Part 2 – Expansion: Incidence and frequency of AEs, SAEs, DLTs, AEs leading to discontinuation, deaths, vital signs, ECG abnormalities, LVEF, and clinically significant laboratory abnormalities.
Detailed description
Part 1 – Dose Finding: Overall Response Rate (ORR) will be defined according to RECIST v1.1., Part 1 and Part 2: Duration of Response (DOR), Disease Control Rate (DCR defined as the proportion of participants with a best response of partial response [PR], complete response [CR] or prolonged stable disease [SD]), progression-free-survival (PFS, time from starting treatment until disease progression or death for any reason) will be defined according to RECIST v1.1., Part 1 and Part 2: Summary measures of PK parameters of EOS-448 and incidence of anti-drug antibodies (ADA) to EOS-448., Part 1 and Part 2: Summary measures of PK parameters of inupadenant., Part 1 and Part 2: Summary measures of PK parameters of dostarlimab and incidence of anti-drug antibodies (ADA) to dostarlimab.
Interventions
DRUGJEMPERLI 500 mg concentrate for solution for infusion
DRUGInupadenant
DRUGInupadenant HCl
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
iTeos Belgium
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 – Dose Finding: Incidence and frequency of adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), AEs leading to discontinuation, deaths, vital signs, electrocardiogram (ECG) abnormalities, LVEF, and clinically significant laboratory abnormalities., Part 2 – Expansion: Overall Response Rate (ORR) will be defined according to RECIST v1.1., Part 2 – Expansion: Incidence and frequency of AEs, SAEs, DLTs, AEs leading to discontinuation, deaths, vital signs, ECG abnormalities, LVEF, and clinically significant laboratory abnormalities. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 – Dose Finding: Overall Response Rate (ORR) will be defined according to RECIST v1.1., Part 1 and Part 2: Duration of Response (DOR), Disease Control Rate (DCR defined as the proportion of participants with a best response of partial response [PR], complete response [CR] or prolonged stable disease [SD]), progression-free-survival (PFS, time from starting treatment until disease progression or death for any reason) will be defined according to RECIST v1.1., Part 1 and Part 2: Summary measures of PK parameters of EOS-448 and incidence of anti-drug antibodies (ADA) to EOS-448., Part 1 and Part 2: Summary measures of PK parameters of inupadenant., Part 1 and Part 2: Summary measures of PK parameters of dostarlimab and incidence of anti-drug antibodies (ADA) to dostarlimab. | — |
Countries
Belgium, France, Italy, Spain
Outcome results
None listed