Advanced solid tumors
Conditions
Brief summary
Incidence of DLTs during Cycle 1 of treatment (Phase 1), Incidence and severity of AEs, SAEs and TEAEs; safety parameters variations from baseline (Phase 1), Tolerability – Frequency of dose interruptions, dose reductions and dose intensity achieved (Phase 1), ORR assessed using RECIST v1.1 (Phase 2), Safety - Incidence and severity of AEs, SAEs and TEAEs; safety parameters variations from baseline (Phase 2), Tolerability – Frequency of dose interruptions, dose reductions and dose intensity achieved (Phase 2), Adherence – treatment diary(Phase 2)
Detailed description
Plasma and urine GTAEXS617 PK parameters including but not limited to: • Cmax, tmax, AUC0-last, AUC(0-inf), AUC(0-tau), accumulation of Cmax (Rcmax) and AUC(0-tau) (RAUC(0-tau)), t1/2, CL/F, and Vz/F (Phase 1 and 2) • By-interval and cumulative GTAEXS617 excretion in urine (Ae and fe), and CLr, GTAEXS617 as monotherapy and in combination with SoC • Plasma GTAEXS617 PK concentrations and, if appropriate, plasma PK parameters DCR, PFS, and DOR, assessed using RECIST (Phase 1 and 2), ORR, according to RECIST v1.1 Phase 1 (monotherapy & combination):
Interventions
DRUGFulvestrant Ribosepharm 250 mg Injektionslösung in einer Fertigspritze
DRUGGTAEXS617
DRUGPaclitaxel Kabi 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Sponsors
Exscientia AI Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of DLTs during Cycle 1 of treatment (Phase 1), Incidence and severity of AEs, SAEs and TEAEs; safety parameters variations from baseline (Phase 1), Tolerability – Frequency of dose interruptions, dose reductions and dose intensity achieved (Phase 1), ORR assessed using RECIST v1.1 (Phase 2), Safety - Incidence and severity of AEs, SAEs and TEAEs; safety parameters variations from baseline (Phase 2), Tolerability – Frequency of dose interruptions, dose reductions and dose intensity achieved (Phase 2), Adherence – treatment diary(Phase 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma and urine GTAEXS617 PK parameters including but not limited to: • Cmax, tmax, AUC0-last, AUC(0-inf), AUC(0-tau), accumulation of Cmax (Rcmax) and AUC(0-tau) (RAUC(0-tau)), t1/2, CL/F, and Vz/F (Phase 1 and 2) • By-interval and cumulative GTAEXS617 excretion in urine (Ae and fe), and CLr, GTAEXS617 as monotherapy and in combination with SoC • Plasma GTAEXS617 PK concentrations and, if appropriate, plasma PK parameters DCR, PFS, and DOR, assessed using RECIST (Phase 1 and 2), ORR, according to RECIST v1.1 Phase 1 (monotherapy & combination): | — |
Countries
Belgium
Outcome results
None listed