Iza-bren + Adagrasib for Lung Cancer

MV
Overseen ByMarcelo V Negrao, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of two drugs, Izalontamab Brengitecan and Adagrasib, to determine if they outperform current treatments for a specific type of lung cancer. It targets individuals with advanced non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation and has not responded to other treatments. This trial may suit those whose lung cancer continues to progress despite using KRAS G12C inhibitors. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.

Will I have to stop taking my current medications?

The trial requires that your most recent systemic therapy, like chemotherapy or immunotherapy, be stopped at least 2 weeks before starting the study drugs. If you are on other medications, the protocol does not specify if they need to be stopped, so it's best to discuss this with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of Izalontamab Brengitecan (iza-bren) and Adagrasib is under evaluation for safety in patients with advanced lung cancer. Previous studies have primarily assessed how well patients tolerate these drugs together.

Adagrasib has demonstrated promising results in past studies, with patients living about 14.74 months on average, suggesting it is somewhat effective and generally manageable.

Izalontamab Brengitecan, a drug targeting cancer cells, has been effective in 45% of patients in certain studies. While specific side effects weren't detailed, this success rate often indicates reasonable tolerability.

As this is an early-phase trial, the primary goal is to ensure treatment safety. Although these drugs remain under study, findings so far suggest they are manageable for patients. However, safety and side effects continue to be closely monitored.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Izalontamab Brengitecan (Iza-bren) and Adagrasib for lung cancer because it brings a fresh approach to treatment. While many existing treatments target specific genetic mutations or use chemotherapy, Adagrasib is a KRAS inhibitor, working directly to block a common mutation driving cancer growth. Meanwhile, Iza-bren, administered intravenously, has shown promise in enhancing the immune system's response to cancer. Together, they offer a novel way to tackle lung cancer by both stopping cancer cell growth and boosting the body's natural defenses.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research has shown that Adagrasib targets a specific change in the KRAS G12C gene, often found in some lung cancers. This change promotes cancer growth, and Adagrasib works to block it. Studies indicate that Adagrasib can effectively slow tumor growth in patients with this gene change. Izalontamab Brengitecan, a bispecific antibody-drug conjugate, targets two proteins, EGFR and HER3, which are often involved in cancer growth. In this trial, participants will receive a combination of these two drugs to address different ways cancer cells survive. While promising evidence exists for each drug individually, the effectiveness of using them together to treat lung cancer remains under study.12367

Who Is on the Research Team?

MV

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
See 17 more

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
See 11 more

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?

1

Treatment groups

Experimental Treatment

Group I: Combo Treatment with Izalontamab Brengitecan (IV) + Adagrasib (PO) Q3WExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Phase 1 Study Of Izalontamab Brengitecan + Adagrasib In ...

Primary Objective: To evaluate the safety and tolerability of iza-bren in combination with adagrasib for treatment of KRAS G12C-mutant NSCLC ...

Global advances and future directions in lung cancer care - PMC

The bispecific ADC Izalontamab Brengitecan (EGFR/HER3) reached an ORR of 45%. Additional targets under study include seizure related 6 ...

Bristol Myers Squibb to Present Data at ESMO® 2025 ...

Key data to be presented by Bristol Myers Squibb and its collaborators at ESMO include: First disclosure of results from a global Phase 1 study of izalontamab ...

First-in-Human Data Support Izalontamab in Advanced ...

Izalontamab showed safety and preliminary efficacy in advanced epithelial tumors, with a 4% objective response rate and mild adverse events.

What's new in oncology

With a median follow-up of 17 months, the two groups experienced similar progression-free survival (9.4 versus 8.7 months) and overall survival ...

Adagrasib and Iza-bren in Non-small Cell Lung Cancer - Clinical ...

Primary Objective: To evaluate the safety and tolerability of iza-bren in combination with adagrasib for treatment of KRAS G12C-mutant NSCLC patients that ...

Clinical outcomes and safety profile of adagrasib in KRAS ...

Adagrasib showed a median overall survival (OS) of 14.74 months (95% CI: 12.06–17.42, I² = 40.4%) and progression-free survival (PFS) of 6.80 months (95% CI: ...