iPREDICT
Research type
Research Study
Full title
iPREDICT Trial: A Phase IIB, Open Label, Study of 89Zr-Df-Crefmirlimab PET/CT in Subjects with Selected Advanced or Metastatic Malignancies including Melanoma, Merkel Cell, Renal Cell and Non-Small Cell LungCancers, Scheduled to Receive Standard-of-Care Immunotherapy (IOT) as a Single Agent or Combination, to Predict Response to Therapy
IRAS ID
1004980
Contact name
Katherine Young
Contact email
Sponsor organisation
ImaginAb, Inc.
Eudract number
2021-005610-33
Clinicaltrials.gov Identifier
Research summary
This is a Phase IIb study to investigate if the Investigational Imaging Agent (IIA), [89]Zr-Df-Crefmirlimab, with positron emission tomography/computed tomography (PET/CT) scans can be used to predict if certain types of advanced cancers will respond to immunotherapy treatment (IOT). The types of cancers under investigation in this trial are; Skin (both Melanoma and Merkel Cell), Kidney and Non-Small Cell Lung. Up to 30 days after the screening visit the first infusion of the IIA will be administered. The PET/CT scan will take place approximately 24 hours after this. Patients will then be initiated on their Standard of Care (SOC) IOT within two weeks of this scan. A second administration of IIA will take place four to six weeks after the IOT has been initiated. Again, patients will undergo a PET/CT scan approximately 24 hours after this. Patients will receive SOC imaging (CTs or MRIs) whilst they are receiving their IOT to determine the status of their disease. If the physician determines that a patient is not responding to IOT treatment they will be given the option to receive one further administration of IIA and a PET/CT scan to gather additional data. Patients responding to IOT will be followed up to 48 weeks after the start of IIA. Any CT or MRI scans undertaken as SOC will be collected. A final visit will take place after 48 weeks of IOT or when the IOT ends (whichever occurs first). This will only involve safety assessments. No further administration of IIA or scans will take place at this visit. This study will include a total of 80 subjects from different countries. In the UK, it is expected that about 30 subjects will take part. The study will be open to recruitment for approximately 18 months. Each patient will be in the study for up to 12 months and have 6 or 8 visits depending on their health status. The study already started in the United States at the end of 2021 and should complete by mid-2024.
REC name
London - Harrow Research Ethics Committee
REC reference
22/LO/0283
Date of REC Opinion
6 May 2022
REC opinion
Further Information Favourable Opinion