Relapsed / Refractory Metastatic or Advanced Solid Tumors
Conditions
Brief summary
Part 1 (Phase I), dose escalation cohorts/Part 2 Group E: • Frequency and nature of AEs, SAEs and DLTs. • Determination of the RP2D., Part 2 (Phase II): safety expansion and efficacy groups: • Frequency and nature of AEs and SAEs. The following will be assessed locally by RECIST v1.1, where applicable: • ORR • DoR • PFS • OS • CBR • CPR, when applicable
Detailed description
Part 1 (Phase I), dose escalation cohorts/Part 2 Group E The following will be assessed locally by RECIST v1.1, where applicable: • ORR • DoR • PFS • OS • CBR • CPR, when applicable PK variables including: • Cmax, Cmin, Tmax, t1/2, AUCtau, Part 2 (Phase II): safety expansion and efficacy groups •Using population PK modelling and subgroup analysis, PK variables including, as possible, Cmax, Cmin, Tmax, t1/2, and AUCtau
Interventions
Sponsors
Ryvu Therapeutics S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 (Phase I), dose escalation cohorts/Part 2 Group E: • Frequency and nature of AEs, SAEs and DLTs. • Determination of the RP2D., Part 2 (Phase II): safety expansion and efficacy groups: • Frequency and nature of AEs and SAEs. The following will be assessed locally by RECIST v1.1, where applicable: • ORR • DoR • PFS • OS • CBR • CPR, when applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 (Phase I), dose escalation cohorts/Part 2 Group E The following will be assessed locally by RECIST v1.1, where applicable: • ORR • DoR • PFS • OS • CBR • CPR, when applicable PK variables including: • Cmax, Cmin, Tmax, t1/2, AUCtau, Part 2 (Phase II): safety expansion and efficacy groups •Using population PK modelling and subgroup analysis, PK variables including, as possible, Cmax, Cmin, Tmax, t1/2, and AUCtau | — |
Countries
Poland, Spain
Outcome results
None listed