44 Participants Needed

Tarlatamab for Brain Tumor

EC
Overseen ByEric Chen, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

EC

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

Patients must have a life expectancy ≥ 12 weeks
I am fully active or can carry out light work.
Provision of informed consent prior to any study specific procedures
See 15 more

Exclusion Criteria

I have had issues with my pituitary gland.
Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational products or interpretation of patient safety or study results
History of allergic reaction attributed to compounds of similar chemical or biologic composition to tarlatamab
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Cohort 1: Up to 3 cycles of tarlatamab prior to surgical resection; Cohort 2: Tarlatamab every 2 weeks in 28-day cycles

12 weeks for Cohort 1; Until progression for Cohort 2

Surgical Resection (Cohort 1)

Patients undergo surgical resection after up to 3 cycles of tarlatamab

1 week

Post-operative Treatment (Cohort 1)

Patients may resume tarlatamab treatment post-operatively until disease progression

Until progression

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tarlatamab
Trial Overview The study is testing Tarlatamab's safety and effectiveness on certain brain cancers. As it's a phase 2 trial, it likely involves patients receiving Tarlatamab under close monitoring to see how well it works and what side effects occur.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Group II: Cohort 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Amgen

Industry Sponsor

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Published Research Related to This Trial

Malignant brain tumors remain difficult to treat, with long-term survival only improving from 6 to 15 months over the last 80 years, despite advancements in surgery, chemotherapy, and radiotherapy.
Immunotherapy, particularly using immune modulators like CTLA-4 and PD-1/PD-L1, is being actively researched in ongoing phase I and III trials, showing promise in targeting glioma antigens, but challenges remain in achieving complete responses and understanding the lack of adverse brain inflammation in these patients.
The value of EGFRvIII as the target for glioma vaccines.Lowenstein, PR., Castro, MG.[2021]

Citations

Real-World Outcomes of Tarlatamab in Small Cell Lung ...After a median follow-up of 6.7 months, the overall response rate (ORR) was 42.9% in SCLC patients. Conclusions. Tarlatamab is a promising treatment option for ...
DeLLphi-300 Trial Update | Journal of Clinical OncologyWith tarlatamab treatment, CNS tumor shrinkage of ≥30% occurred in 62.5% of patients who had baseline CNS lesions ≥10 mm, including in a subset ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40280845/
Real-World Outcomes of Tarlatamab in Small Cell Lung ...We observed higher rates of CRS and ICANS during the first treatment cycle suggesting that real-world safety outcomes may differ from clinical trial data.
Tarlatamab May Offer New SOC for Relapsed ES-SCLC ...Tarlatamab has demonstrated superior efficacy, showing "superior progression-free survival [PFS] and overall survival [OS]" in patients with ...
Investigators Report Efficacy, Safety Analysis of Tarlatamab in ...Tarlatamab demonstrated durable response with promising survival regardless of the presence of treated, stable brain metastases at baseline.
NCT06776250 | Study of How Safe and Effective ...This is a phase 2 study to assess how useful study drug tarlatamab is for the treatment of patients with recurrent/refractory oligodendroglioma or astrocytoma
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