Solid Tumors
Conditions
Brief summary
• Incidence of DLTs (Part 1 and Part 2 safety lead-ins only), • Incidence of AEs, TRAEs, SAEs, and clinically significant changes in laboratory test values and vital signs
Detailed description
• RAS(ON) inhibitor concentrations over time as applicable, • ORR and DOR per RECIST v1.1, • DCR, TTR and PFS per RECIST v1.1, • Ivonescimab serum concentrations over time as applicable, • Number and percentage of patients with detectable anti-ivonescimab antibody (ADA) at baseline and post treatment
Interventions
Sponsors
Revolution Medicines Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Incidence of DLTs (Part 1 and Part 2 safety lead-ins only), • Incidence of AEs, TRAEs, SAEs, and clinically significant changes in laboratory test values and vital signs | — |
Secondary
| Measure | Time frame |
|---|---|
| • RAS(ON) inhibitor concentrations over time as applicable, • ORR and DOR per RECIST v1.1, • DCR, TTR and PFS per RECIST v1.1, • Ivonescimab serum concentrations over time as applicable, • Number and percentage of patients with detectable anti-ivonescimab antibody (ADA) at baseline and post treatment | — |
Outcome results
None listed