Iza-bren + Adagrasib for Lung Cancer

Overseen By Marcelo V Negrao, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Investigational agents

Disqualifiers: Untreated brain metastases, Pneumonitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Marcelo V Negrao, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced KRAS G12C-mutant non-small cell lung cancer (NSCLC) that has not improved with previous treatments. Participants must have tried a KRAS G12C inhibitor before and their cancer should still be growing.

Inclusion Criteria

I stopped my last cancer treatment at least 2 weeks ago.

Patients must have measurable disease per RECIST v1.1

Patients with a history of hepatitis C virus (HCV) infection must have documentation of undetectable HCV viral load

Exclusion Criteria

Patients who are receiving any other investigational agents

Patients with psychiatric illness/social situations that would limit compliance with study requirements

History of allergic reactions attributed to compounds of similar chemical or biologic composition to adagrasib and iza-bren

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Izalontamab Brengitecan (IV) and Adagrasib (PO) in a 21-day cycle

12 months

IV on Day 1 and Day 8 (+3 days) every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adagrasib
• Izalontamab Brengitecan

Trial Overview

The study tests combining Izalontamab Brengitecan (iza-bren) and Adagrasib to see if they work better than current treatments for NSCLC patients who haven't responded well to KRAS G12C inhibitors.

How Is the Trial Designed?

Group I: Combo Treatment with Izalontamab Brengitecan (IV) + Adagrasib (PO) Q3W Experimental Treatment 2 Interventions

Adagrasib will be administered at 400mg PO BID continuously. Iza-bren will be administered IV on Day 1 and Day 8 (+3 days) in a 21-day cycle.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+