Advanced ROS1-positive NSCLC and other advanced ROS1-positive solid tumors
Conditions
Brief summary
Phase 1 • RP2D and, if applicable, the MTD as determined by incidence of DLTs during Cycle 1, overall safety profile, PK, PD, and preliminary efficacy Phase 2 • ORR per RECIST 1.1.
Detailed description
• Incidence and severity of treatment-emergent adverse events (TEAEs) and changes in clinically relevant laboratory parameters • Pharmacokinetic parameters of NVL-520 − Maximum plasma concentration (Cmax); Cmax – dose normalized, plasma concentration at the end of the dosing interval (Ctau); average plasma concentration (Cavg); time of maximum concentration (Tmax); Please refer to protocol for further end points due to word limitation.
Interventions
DRUGNVL-520
Sponsors
Nuvalent Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 • RP2D and, if applicable, the MTD as determined by incidence of DLTs during Cycle 1, overall safety profile, PK, PD, and preliminary efficacy Phase 2 • ORR per RECIST 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Incidence and severity of treatment-emergent adverse events (TEAEs) and changes in clinically relevant laboratory parameters • Pharmacokinetic parameters of NVL-520 − Maximum plasma concentration (Cmax); Cmax – dose normalized, plasma concentration at the end of the dosing interval (Ctau); average plasma concentration (Cavg); time of maximum concentration (Tmax); Please refer to protocol for further end points due to word limitation. | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain
Outcome results
None listed