Astrocytic TumorPhase 2NCT06776250
Study of How Safe and Effective Tarlatamab is in Brain Cancers
A Phase 2 study testing Tarlatamab in people with Astrocytic Tumor and Oligodendroglial Tumor, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astrocytic Tumor, Oligodendroglial Tumor
- What is being tested?
- Tarlatamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 18 Aug 2025to 3 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures.
- Must be 18 years of age or older.
- Body weight > 40 kg.
- Patients must have histologically or cytologically confirmed diffuse astrocytic or oligodendroglial tumors by World Health Organization 2016 classification which are IDH mutant.
- Patients could have received up to 2 regimens of systemic therapy after relapse.
- For Cohort 1: Patient must be clinically deemed resectable and a resection is clinically indicated.
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- For Cohort 2: Patient must be unresectable or a resection is not clinically indicated at the time of enrollment.
- Patients must have normal organ and bone marrow function measured within 14 days prior to administration of study treatment
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients must have a life expectancy ≥ 12 weeks.
- Patients of childbearing potential must have a negative serum pregnancy test within 28 days prior to start of therapy and Day 1 prior to start of therapy.
- All participants must agree to use 2 acceptable methods to prevent pregnancy for study required duration.
- Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- All patients in Cohort 1 and Cohort 2 are required to submit archival tissue. In addition,
- Patients in Cohort 1 must be willing to provide fresh tumor samples at the time of clinically indicated surgical resection/debulking, or willing to undergo post-treatment tumor biopsy.
- Patients in Cohort 2 must be willing to provide tumor samples should they require surgical resection/debulking or undergo clinically indicated tumor biopsy after enrollment in trial.
- Patients in Cohort 2 must have measurable and progressive disease documented within 28 days of start of study treatment
- Patients must be asymptomatic and meet the following criteria:
- At least 28 days after the most recent CNS treatment, clinically stable.
- At least 14 days on stable doses of corticosteroids and/or anti-seizure medications.
Who cannot join
- Concurrent enrollment in another clinical study, unless it is an observational (non-intervention) clinical study or the follow-up period of an interventional study.
- Receipt of any conventional or investigational anticancer therapy within 28 days prior to the first dose of tarlatamab.
- Any previous treatment with tarlatamab.
- Other malignancy within the last 5 years with exceptions.
- Patients receiving any systemic chemotherapy or radiotherapy within 28 days prior to study treatment.
- Unresolved toxicity from prior anti-tumor therapy or prior surgery.
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- Major surgery within 28 days of starting study treatment and patients must have recovered from any effects of any major surgery.
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
- History of arterial thrombosis within 12 months of first dose of tarlatamab.
- Patients who are pregnant, lactating, or intend to become pregnant during their participation in this study.
- Patients with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of tarlatamab.
- Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV), or those who have had a solid organ transplant or allogeneic transplant.
- History of hypophysitis or pituitary dysfunction.
- Exclusion of hepatitis infection based on the following results and/or criteria (within 3 months prior to the first dose of tarlatamab):
- Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B).
- Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.
- Positive hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.
- Whole blood transfusions within 120 days prior to enrollment to the study (packed red blood cells and platelet transfusions are acceptable outside of 28 days prior to treatment).
- Current or prior use of immunosuppressive medications within 14 days before the 1st dose of tarlatamab. Patients receiving systemic corticosteroids must have been on a stable dose of corticosteroids for at least 14 days prior to the 1st dose of tarlatamab.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, celiac disease, and Wegner syndrome) within the last 2 years. Patients with vitiligo, alopecia, Grave's disease, hypothyroidism stable on hormone replacement, or psoriasis not requiring systemic treatment (within the past 3 years) are not excluded.
- 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.
- Receipt of live attenuated vaccines within 30 days prior to the 1st dose of tarlatamab, during the study and for 30 days after the last dose of tarlatamab. Examples include, but are not limited to, vaccines for measles, mumps, and rubella, live attenuated influenza vaccine (nasal), chicken pox vaccine, oral polio vaccine, rotavirus vaccine, yellow fever vaccine, BCG vaccine, typhoid vaccine and typhus vaccine.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice).
- History of allergic reaction attributed to compounds of similar chemical or biologic composition to tarlatamab.
- Patients unable to remain within one hour of study site for additional 48 hours after hospitalization on cycle 1 day 1 and cycle 1 day 8.
- Patients unable to remain within one hour of any hospital for 72 hours after infusion of tarlatamab on cycle 1 day 1 and cycle 1 day 8.
- Patients unable to identify home companion who will cohabitate with subject for 72 hours after infusion of tarlatamab on cycle 1 day 1 and cycle 1 day 8.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Eric Chen, MD, 416-946-2263, eric.chen@uhn.ca
Eric Chen, MD
About this study
Official title: A Phase II Study Evaluating the Safety, Efficacy, and Intracranial Activity of Tarlatamab in Recurrent/Refractory Gliomas With IDH Mutation (TARGID)
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.
Read the detailed description
There will be 2 cohorts in the study.
- Cohort 1, 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.
- Cohort 2, patients with progressive/refractory disease are eligible to receive tarlatamab at Q2W 10 mg dosing in 28 day cycles until documented disease progression, intolerable toxicity or consent withdrawal. The Simon's 2 stage design will be used. In stage 1, 13 patients will be enrolled. Based on an interim analysis of efficacy, stage 2 will aim to enroll an additional 21 patients for a total of 34 patients.
- Conditions
- Astrocytic Tumor, Oligodendroglial Tumor
- Being tested
- Tarlatamab
- Medical subject headings
- Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarlatamabDrug
Tarlatamab is a BiTE molecule designed to direct T effector cells toward DLL3-expressing cells.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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. Receives: Drug: Tarlatamab |
| Cohort 2 | Experimental | 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. Receives: Drug: Tarlatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in CD8+ T cell infiltrate
Measured: 3 years
Secondary outcomes (5)
Percent change in CD3/CD45RA/RO T cells
Measured: 3 years
Percent change in T cell subsets
Measured: 3 years
Percentage change in M1 vs M2 macrophage populations
Measured: 3 years
Tumour concentrations of tarlatamab
Measured: 3 years
Serum concentrations of tarlatamab
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start18 Aug 2025
- Primary completion3 Mar 2028 (estimated)
- Study completion3 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Astrocytic TumorStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Eric Chen, MD, Principal investigator, Princess Margaret Cancer Centre/University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776250
- Sponsor's protocol ID
- TARGID
- Other IDs
- CAPCR 24-5801
- Status last verified
- Sep 2025
- First submitted
- 9 Jan 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating the Safety, Efficacy, and Intracranial Activity of Tarlatamab in Recurrent/Refractory Gliomas With IDH Mutation (TARGID)
- ClinicalTrials.gov ID
- NCT06776250
- Acronym / sponsor ID
- TARGID
- Conditions
- Astrocytic Tumor, Oligodendroglial Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 3 Mar 2028 (estimated)
- Study completion
- 3 Mar 2028 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There will be 2 cohorts in the study.
- Cohort 1, 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.
- Cohort 2, patients with progressive/refractory disease are eligible to receive tarlatamab at Q2W 10 mg dosing in 28 day cycles until documented disease progression, intolerable toxicity or consent withdrawal. The Simon's 2 stage design will be used. In stage 1, 13 patients will be enrolled. Based on an interim analysis of efficacy, stage 2 will aim to enroll an additional 21 patients for a total of 34 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: TarlatamabPatients 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. |
| Cohort 2 | Experimental | Drug: TarlatamabPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Provision of informed consent prior to any study specific procedures.
- Must be 18 years of age or older.
- Body weight > 40 kg.
- Patients must have histologically or cytologically confirmed diffuse astrocytic or oligodendroglial tumors by World Health Organization 2016 classification which are IDH mutant.
- Patients could have received up to 2 regimens of systemic therapy after relapse.
Key exclusion criteria (27 listed)
- Concurrent enrollment in another clinical study, unless it is an observational (non-intervention) clinical study or the follow-up period of an interventional study.
- Receipt of any conventional or investigational anticancer therapy within 28 days prior to the first dose of tarlatamab.
- Any previous treatment with tarlatamab.
- Other malignancy within the last 5 years with exceptions.
- Patients receiving any systemic chemotherapy or radiotherapy within 28 days prior to study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TarlatamabTarlatamab is a BiTE molecule designed to direct T effector cells toward DLL3-expressing cells. | Drug | Cohort 1, Cohort 2 |
Primary outcome
Percent change in CD8+ T cell infiltrate
Time frame: 3 years
5 secondary outcomes
Percent change in CD3/CD45RA/RO T cells
Time frame: 3 years
Percent change in T cell subsets
Time frame: 3 years
Percentage change in M1 vs M2 macrophage populations
Time frame: 3 years
Tumour concentrations of tarlatamab
Time frame: 3 years
Serum concentrations of tarlatamab
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Chen, MD principal investigator
Princess Margaret Cancer Centre/University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tarlatamab in people with Astrocytic Tumor and Oligodendroglial Tumor, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Chen, MD (416-946-2263, eric.chen@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in CD8+ T cell infiltrate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.