Patients with advanced solid malignancies that have progressed following standard therapy
Conditions
Brief summary
Phase 1: - Frequency of dose-limiting toxicities (DLTs) - Frequency and severity of AEs, including abnormal ECG parameters, and serious adverse events (SAEs), Phase 2: Objective response rate
Detailed description
Phase 1: -Plasma concentrations of ETX-19477 as a function of time post-dosing -PK parameters for single (first) dose and multiple doses, Phase 1: - Objective response rate (ORR) - Duration of response (DOR) - Disease control rate (DCR) - Progression-free survival (PFS), Phase 2: - Frequency and severity of AEs and SAEs., Phase 2: - Duration of response (DOR) - Disease control rate (DCR) - Progression-free survival (PFS)
Interventions
DRUGETX-19477
Sponsors
858 Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: - Frequency of dose-limiting toxicities (DLTs) - Frequency and severity of AEs, including abnormal ECG parameters, and serious adverse events (SAEs), Phase 2: Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1: -Plasma concentrations of ETX-19477 as a function of time post-dosing -PK parameters for single (first) dose and multiple doses, Phase 1: - Objective response rate (ORR) - Duration of response (DOR) - Disease control rate (DCR) - Progression-free survival (PFS), Phase 2: - Frequency and severity of AEs and SAEs., Phase 2: - Duration of response (DOR) - Disease control rate (DCR) - Progression-free survival (PFS) | — |
Countries
France, Italy, Spain
Outcome results
None listed