advanced solid tumors
Conditions
Brief summary
Phase 1 - Inclusive of all aspects of safety, tolerability, biologic activity, PK, pharmacodynamics (PD) and preliminary efficacy, Phase 1 - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs), Phase 2A - Objective Response Rate (ORR), Phase 2A - Duration of response (DOR), Phase 2A - Disease control rate (DCR), Phase 2A - Progression free survival (PFS), Phase 2A - Frequency and severity of AEs and SAEs
Detailed description
Phase 1 - Objective Response Rate (ORR), Phase 1 - Duration of response (DOR), Phase 1 - Disease control rate (DCR), Phase 1 - Progression free survival (PFS), Phase 1 and 2A- Plasma concentrations of OTP-01 as a function of time post-dosing, Phase 1 and 2A- PK parameters (area under the curve [AUC], maximum plasma concentration [Cmax], minimum plasma concentration [Cmin], time of maximum concentration [Tmax], half-life [t1/2], clearance [CL]) for single (first) dose and multiple doses
Interventions
None listed
Sponsors
Ottimo Pharma Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 - Inclusive of all aspects of safety, tolerability, biologic activity, PK, pharmacodynamics (PD) and preliminary efficacy, Phase 1 - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs), Phase 2A - Objective Response Rate (ORR), Phase 2A - Duration of response (DOR), Phase 2A - Disease control rate (DCR), Phase 2A - Progression free survival (PFS), Phase 2A - Frequency and severity of AEs and SAEs | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1 - Objective Response Rate (ORR), Phase 1 - Duration of response (DOR), Phase 1 - Disease control rate (DCR), Phase 1 - Progression free survival (PFS), Phase 1 and 2A- Plasma concentrations of OTP-01 as a function of time post-dosing, Phase 1 and 2A- PK parameters (area under the curve [AUC], maximum plasma concentration [Cmax], minimum plasma concentration [Cmin], time of maximum concentration [Tmax], half-life [t1/2], clearance [CL]) for single (first) dose and multiple doses | — |
Outcome results
None listed