Tarlatamab for Brain Tumor
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of a new drug, tarlatamab, for treating certain brain tumors. It targets tumors called oligodendroglioma and astrocytoma, which have a specific gene mutation known as IDH. The trial includes two groups: one for patients eligible for surgery and another for those who are not. This trial may suit individuals with these specific brain tumors who experience tumor growth despite previous treatments. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you must be on stable doses of corticosteroids and/or anti-seizure medications for at least 14 days before starting the study treatment.
Is there any evidence suggesting that tarlatamab is likely to be safe for humans?
Research has shown that tarlatamab caused some side effects in earlier studies. Patients who took tarlatamab for other conditions reported issues like cytokine release syndrome (CRS), which can cause fever and tiredness, and ICANS, a condition affecting the brain that can lead to confusion. These side effects appeared more frequently at the beginning of treatment.
On the positive side, promising evidence indicates that tarlatamab can shrink brain tumors, reducing their size by at least 30% in many patients. This suggests the treatment is effective, despite some side effects.
It's important to note that these findings come from studies with patients who had different types of cancer. In this trial, researchers are testing tarlatamab specifically for brain tumors with an IDH mutation. For questions or concerns, discussing with a doctor can provide more understanding of the potential risks and benefits.12345Why do researchers think this study treatment might be promising for brain tumors?
Researchers are excited about tarlatamab for brain tumors because it represents a novel approach compared to traditional treatments like surgery, radiation, and chemotherapy. Unlike these standard options, which generally aim to remove or kill tumor cells directly, tarlatamab works by engaging the body's immune system to specifically target and attack cancer cells. This immunotherapy approach could potentially lead to more precise and effective treatments with fewer side effects. Moreover, tarlatamab's ability to be administered both before and after surgical resection provides flexibility in treatment and could enhance outcomes by addressing residual disease.
What evidence suggests that tarlatamab might be an effective treatment for brain tumors?
Research has shown that tarlatamab yields promising results in treating certain cancers. One study found that it helped shrink brain tumors by 30% or more in 62.5% of patients with specific initial tumor characteristics. This trial will evaluate tarlatamab in two different cohorts: Cohort 1 involves patients whose disease is amenable to resection, receiving up to 3 cycles of tarlatamab before surgical resection, while Cohort 2 includes patients with progressive or refractory disease receiving tarlatamab every 2 weeks. In small cell lung cancer, tarlatamab demonstrated a response rate of 42.9%, indicating its potential in treating cancers that affect the brain. Overall, these findings highlight tarlatamab's potential effectiveness in treating brain tumors with genetic mutations.23456
Who Is on the Research Team?
Eric Chen, MD
Principal Investigator
Princess Margaret Cancer Centre/University Health Network
Are You a Good Fit for This Trial?
This trial is for patients with recurrent or refractory oligodendroglioma or astrocytoma brain cancers that have a specific mutation in the IDH gene. Details about who can join are not fully provided, but typically participants need to meet certain health standards and may be required to have tried other treatments first.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Cohort 1: Up to 3 cycles of tarlatamab prior to surgical resection; Cohort 2: Tarlatamab every 2 weeks in 28-day cycles
Surgical Resection (Cohort 1)
Patients undergo surgical resection after up to 3 cycles of tarlatamab
Post-operative Treatment (Cohort 1)
Patients may resume tarlatamab treatment post-operatively until disease progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tarlatamab
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Amgen
Industry Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London