Combination Of Izalontamab Brengitecan And Adagrasib In Advanced KRAS G12Ci-Refractory Non-Small Cell Lung Cancer - The IZA-A Trial
M.D. Anderson Cancer Center
Summary
This research is being done to test a combination of two drugs, Izalontamab Brengitecan (iza-bren) and Adagrasib, in patients with advanced KRAS G12C-mutant NSCLC that hasn't responded to other treatments. The purpose is to see if this combination works better than existing treatments for people whose cancer keeps growing despite KRAS G12C inhibitors.
Description
Primary Objective: To evaluate the safety and tolerability of iza-bren in combination with adagrasib for treatment of KRAS G12C-mutant NSCLC patients that progressed on KRAS G12C inhibitors. Secondary Objectives: * To evaluate the preliminary efficacy of iza-bren in combination with adagrasib for treatment of KRAS G12C-mutant NSCLC patients that progressed on KRAS G12C inhibitors. * To evaluate the pharmacokinetics of iza-bren upon combination treatment with adagrasib. * To evaluate immunogenicity against iza-bren upon combination treatment with adagrasib. * To evaluate the incidence of ant…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have histologically or cytologically confirmed diagnosis of NSCLC or NSCLC predominant histology. * Patients must have a diagnosis of metastatic or locally advanced NSCLC not amenable to curative therapy * Tumor must harbor a KRAS G12C mutation. Testing available through multigene NGS panels performed in the Molecular Diagnostics Laboratory in UT MD Anderson Cancer Center and can be performed using either tissue or blood assays. Use of standard of care (SOC) results are allowed to meet this requirement. * Patients must have progressed on a prior KRAS G12C i…
Interventions
- DrugAdagrasib
Given by mouth
- DrugIza-bren
Given by IV
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas