NCT07382726

Phase 1 Study Of Izalontamab Brengitecan + Adagrasib In NSCLC - The IZA-A Trial

Combination Of Izalontamab Brengitecan And Adagrasib In Advanced KRAS G12Ci-Refractory Non-Small Cell Lung Cancer - The IZA-A Trial

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 anti-drug antibody (ADA) formation to Iza-bren when it is administered in combination with adagrasib, and to assess the potential effect of ADA on PK, PD and safety. * To evaluate EGFR and HER3 tumor expression as determinants of clinical outcomes to study regimen. * To evaluate circulating tumor DNA (ctDNA) as a determinant of clinical outcome to study regimen. * To evaluate mechanisms of resistance to study regimen.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Adagrasib	Given by mouth
DRUG	Iza-bren	Given by IV

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-12-24
• Completion: 2029-12-24
• First posted: 2026-02-03
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study