Actively Recruiting
Study of How Safe and Effective Tarlatamab is in Brain Cancers
Led by University Health Network, Toronto · Updated on 2025-09-19
44
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of How Safe and Effective Tarlatamab is in Brain Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must provide informed consent before any study procedures
- Must be 18 years of age or older
- Body weight greater than 40 kg
- Have histologically or cytologically confirmed diffuse astrocytic or oligodendroglial tumors with IDH mutation
- May have received up to 2 prior systemic therapy regimens after relapse
- For Cohort 1: tumor must be deemed resectable and surgery clinically indicated
- For Cohort 2: tumor must be unresectable or surgery not clinically indicated
- Must have normal organ and bone marrow function within 14 days before treatment
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy of at least 12 weeks
- Negative pregnancy test within 28 days prior to and on Day 1 of therapy for patients of childbearing potential
- Agree to use two acceptable pregnancy prevention methods during the study
- Willing and able to follow study protocol including treatment and visits
- Must submit archival tumor tissue samples
- Cohort 1 patients must provide fresh tumor samples at surgery or post-treatment biopsy
- Cohort 2 patients must provide tumor samples if undergoing surgery or biopsy after enrollment
- For Cohort 2: must have measurable and progressive disease within 28 days before treatment
- Must be asymptomatic and clinically stable at least 28 days after last CNS treatment
- Must be on stable doses of corticosteroids and/or anti-seizure medications for at least 14 days
You will not qualify if you...
- Concurrent enrollment in another interventional clinical study (non-interventional studies allowed)
- Received any anticancer therapy within 28 days before first dose of tarlatamab
- Prior treatment with tarlatamab
- Other malignancy within last 5 years except certain exceptions
- Receiving systemic chemotherapy or radiotherapy within 28 days before treatment
- Unresolved side effects from prior cancer treatment or surgery
- Major surgery within 28 days before treatment and not fully recovered
- Serious uncontrolled medical disorders or infections
- History of arterial thrombosis within 12 months before treatment
- Pregnant, lactating, or planning pregnancy during study
- Active or uncontrolled systemic infection within 7 days before treatment
- Immunocompromised status including HIV positive or organ transplant
- History of hypophysitis or pituitary dysfunction
- Hepatitis B or C infection based on recent testing
- Whole blood transfusion within 120 days before enrollment
- Use of immunosuppressive medications within 14 days before treatment
- Active or recent autoimmune or inflammatory disorders within last 2 years except certain stable conditions
- Any condition interfering with study evaluation or safety
- Receipt of live attenuated vaccines within 30 days before, during, or 30 days after treatment
- Active tuberculosis infection
- Allergic reaction to compounds similar to tarlatamab
- Unable to stay within one hour of study site or hospital for required monitoring periods after dosing
- Unable to identify a home companion for 72 hours after specific dosing days
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
E
Eric Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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