Study of How Safe and Effective Tarlatamab is in Brain Cancers

NCT06776250 | Recruiting Phase 2 DMC

• 2 other identifiers: TARGIDCAPCR 24-5801
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Astrocytic Tumor; Oligodendroglial Tumor

Outcome Measures

Primary Outcomes (1)

• Percent change in CD8+ T cell infiltrate

  3 years

Secondary Outcomes (5)

• Percent change in CD3/CD45RA/RO T cells

  3 years

• Percent change in T cell subsets

  3 years

• Percentage change in M1 vs M2 macrophage populations

  3 years

• Tumour concentrations of tarlatamab

  3 years

• Serum concentrations of tarlatamab

  3 years

Study Arms (2)

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.

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.

Drug: Tarlatamab

Interventions

Tarlatamab DRUG

Tarlatamab is a BiTE molecule designed to direct T effector cells toward DLL3-expressing cells.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Amgen: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Astrocytoma

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Eric Chen, MD

  Princess Margaret Cancer Centre/University Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Chen, MD

CONTACT

416-946-2263; eric.chen@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 15, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): March 3, 2028
• Study Completion (Estimated): March 3, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)