Tarlatamab for Brain Tumor

Overseen By Eric Chen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Must not be taking: Immunosuppressants, Chemotherapy, Radiotherapy, others

Disqualifiers: Other malignancy, Uncontrolled infection, Autoimmune disorders, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks for Cohort 1; Until progression for Cohort 2

44 Participants Needed

Trial Summary

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.

How is the drug Tarlatamab unique for treating brain tumors?

Tarlatamab is unique because it is an immunotherapy drug that may help the immune system target and destroy brain tumor cells, potentially overcoming the challenge of the blood-brain barrier (BBB) that often limits the effectiveness of other treatments. This approach is part of a broader trend in cancer treatment that uses the body's own immune system to fight tumors. ^{1 2 3 4 5}

What is the purpose of this trial?

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 with a mutation in the IDH gene.

Research Team

Eric Chen, MD

Principal Investigator

Princess Margaret Cancer Centre/University Health Network

Eligibility Criteria

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

I am fully active or can carry out light work.

Patients must have a life expectancy ≥ 12 weeks

Provision of informed consent prior to any study specific procedures

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Cohort 2 Experimental Treatment 1 Intervention

Patients with progressive/refractory disease are eligible to receive tarlatamab at every 2 weeks 10 mg dosing in 28 day cycles until documented disease progression, intolerable toxicity or consent withdrawal. Up to 34 patients may be enrolled to Cohort 2.

Group II: Cohort 1 Experimental Treatment 1 Intervention

Patients whose disease is amendable for resection will be treated with up to 3 cycles of tarlatamab prior to surgical resection. These patients can resume tarlatamab treatment post-operatively until disease progression at the discretion of the investigator. Up to 10 patients may be enrolled to Cohort 1.

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

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

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of EGFRvIII as the target for glioma vaccines. Lowenstein, PR., Castro, MG.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Monoclonal antibodies in neuro-oncology: Getting past the blood-brain barrier. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The value of EGFRvIII as the target for glioma vaccines. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Targeted therapy in brain metastasis. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Brain tumor immunotherapy: seeing the brain in the body. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Enhanced brain entry of checkpoint-inhibitory therapeutic antibodies facilitated by intraarterial NEO100 in mouse models of brain-localized malignancies. [2023]