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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. written informed consent. 2. Men and women over 18 years of age. 3. 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. 4. 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. 5. Eastern Cooperative Oncology Group Performance status of 0 or 1. 6. Adequate organ function. 7. Women of childbearing potential must use two forms of reliable contraception before starting 123I-ATT001 treatment, during therapy and for 6 months after receiving the last dose of 123I-ATT001. All male subjects must agree to not donate sperm during the study and for 6 months after the last dose of study drug. 8. Be able to understand and comply with the requirements of the study, as judged by the Investigator.

Exclusion Criteria:

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. 2. 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. 3. Prior anticancer treatments within the following time periods: 1. Chemotherapy within 4 weeks of enrolment or 5 half-lives, whichever is shorter. 2. Targeted small molecule therapy within 4 weeks of enrolment or 5 half-lives, whichever is shorter. 3. Immunotherapy (including monoclonal antibody therapy) or radiation therapy within 4 weeks prior to study day 1. 4. Unresolved NCI-CTCAE grade 2 or higher toxicity (except stable neurological toxicities/deficits related to disease process, alopecia). 5. Patients with a known allergy to Olaparib or Iodine. 6. Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer. 7. Any condition that precludes the proper performance of SPECT and/or MRI scan. 8. Any clinically significant abnormalities in resting ECG at the time of screening including prolonged QTcF (>450 ms for males; >470 ms for females) and cardiac arrhythmias, as judged by the Investigator or designee. 9. Unstable systemic disease (including but not limited to active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). 10. Psychiatric, substance misuse or functional disorders that prevent subjects from providing informed consent, following protocol instructions or cooperating with the requirements of the study. 11. Active infection requiring systemic therapy. 12. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 3 months after the last dose of study treatment. 13. Subject that has a condition or is in a situation, which in the Investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study. 14. History of non- infectious pneumonitis within the last 3 years.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06650605
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Theragnostics Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Paul Mulholland
Principal Investigator Affiliation University College London Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioma Glioblastoma Multiforme
Study Website: View Trial Website
Additional Details

The main goals of this study are to understand if 123I-ATT001 is safe and tolerable to treat participants with relapsed glioblastoma and to determine the maximum tolerated dose that can be given to participants without any unacceptable side effects. The study consists of two parts:

  • - Part 1 is a dose escalation study where three doses of 123I-ATT001 will be tested, starting with the lowest dose.
When a recommended dose (RD) has been declared, a monotherapy expansion cohort will be open at that dose level. In Part 1 participants will receive a 123I-ATT001 dose, once per week, for four weeks (+ two optional extra cycles).
  • - Part 2 is a dose expansion study where one dose of 123I-AT001 will be tested in combination with other therapies.
Part 2 will begin after the Part 1 has completed and a recommended part 2 dose has been chosen. The specific details and combination therapies for Part 2 of the study will be added via a protocol amendment at a later date.

Arms & Interventions

Arms

Experimental: Part 1 Dose Escalation & Dose Expansion

Dose Escalation: 123I-ATT001 Dose Level 1 123I-ATT001 Dose Level 2 123I-ATT001 Dose Level 3 Dose Expansion: 123I-ATT001 Recommended Dose from Dose Escalation

Interventions

Drug: - 123I-ATT001

123I-ATT001

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University College London Hosptial, London, United Kingdom

Status

Recruiting

Address

University College London Hosptial

London, ,

Site Contact

Paul Mulholland, Dr

[email protected]

+44 (0) 20 3355 1546

University Hospital Southampton, Southampton, United Kingdom

Status

Not yet recruiting

Address

University Hospital Southampton

Southampton, ,

Site Contact

Jeng Ching, Dr

[email protected]

+44 (0) 20 3355 1546