Clinical Trial · NCT06650605

Phase 1 Open-label Study of 123I-ATT001 in Subjects With Relapsed Glioblastoma

Overview

Phase I open-label trial of 123I-ATT001 monotherapy and in combination with treatment therapies in subjects with relapsed glioblastoma.

Sponsor

Ariceum Therapeutics GmbH

Phase

Phase 1

Contacts

Paul Mulholland (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

Drug / Compound

Isotope(s):

Target(s):

Eligibility

Documented recurrent disease (radiological, based on RANO v.1.0) within 3 months prior to first study drug administration with no suitable standard of care options available.
1. written informed consent
Eastern Cooperative Oncology Group Performance status of 0 or 1.
Histologically confirmed recurrent glioblastoma (grade IV) as per WHO criteria 2021 (IDH- wild type only) where the subjects have an Ommaya reservoir in an intralesional cavity of at least 5 mL volume.
Men and women over 18 years of age.

Prior anticancer treatments within the following time periods:
Chemotherapy within 4 weeks of enrolment or 5 half-lives, whichever is shorter.
1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
Targeted small molecule therapy within 4 weeks of enrolment or 5 half-lives, whichever is shorter.
Diagnosis of immunodeficiency or receiving systemic steroid therapy of up to 4 mg/ day dexamethasone or equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.