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Trial Title:
Phase 1 Open-label Study of 123I-ATT001 in Subjects with Relapsed Glioblastoma
NCT ID:
NCT06650605
Condition:
Glioma Glioblastoma Multiforme
Conditions: Official terms:
Glioblastoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
123I-ATT001
Description:
123I-ATT001
Arm group label:
Part 1 Dose Escalation & Dose Expansion
Summary:
Phase I open-label trial of 123I-ATT001 monotherapy and in combination with treatment
therapies in subjects with relapsed glioblastoma.
Detailed description:
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University College London Hosptial
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Paul Mulholland, Dr
Facility:
Name:
University Hospital Southampton
Address:
City:
Southampton
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Jeng Ching, Dr
Start date:
July 4, 2024
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Theragnostics Ltd
Agency class:
Industry
Source:
Theragnostics Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06650605
https://ariceum-therapeutics.com/pipeline/rparpi/
