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    Summary
    EudraCT Number:2021-005610-33
    Sponsor's Protocol Code Number:IAB-CD8-203
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-06-21
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-005610-33
    A.3Full title of the trial
    iPREDICT Trial: A Phase IIB, Open Label, Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects with Selected Advanced or Metastatic Malignancies including Melanoma, Merkel Cell, Renal Cell and Non-Small Cell Lung
    Cancers, Scheduled to Receive Standard-of-Care Immunotherapy (IOT) as a Single Agent or Combination, to Predict Response to Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    iPREDICT Trial: A study of a new imaging technique that can be used to predict if certain types of cancers will respond to a type of treatment called immunotherapy.
    A.3.2Name or abbreviated title of the trial where available
    iPREDICT
    A.4.1Sponsor's protocol code numberIAB-CD8-203
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05013099
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorImaginAb, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportImaginAb, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImaginAb, Inc.
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street Address423 Hindry Ave. Suite D
    B.5.3.2Town/ cityInglewood, California
    B.5.3.3Post code90301
    B.5.3.4CountryUnited States
    B.5.4Telephone number13106451211
    B.5.6E-mailinfo@imaginab.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameZirconium Zr 89 Crefmirlimab Berdoxam
    D.3.2Product code [89Zr]-Df-IAB22M2C
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN[89Zr]-Df-crefmirlimab
    D.3.9.2Current sponsor code[89Zr]Zr-Df-IAB22M2C
    D.3.9.4EV Substance CodeSUB218013
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    To predict if patients with selected advanced or metastatic malignancies
    including Melanoma, Merkel Cell, Renal Cell and Non-Small Cell Lung
    Cancers, will respond to standard-of-care Immunotherapy as a single agent or combination.
    E.1.1.1Medical condition in easily understood language
    To predict if patients with selected advanced cancers will respond to a type of treatment called Immunotherapy.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10036223
    E.1.2Term Positron emission tomography
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the performance of zirconium Zr 89 crefmirlimab berdoxam positron emission tomography/computed tomography (PET/CT) for predicting patient response to immunotherapy.
    E.2.2Secondary objectives of the trial
    Evaluate the performance of zirconium Zr 89 crefmirlimab berdoxam PET/CT for predicting lesion response to immunotherapy.

    To assess safety of the repeat zirconium Zr 89 crefmirlimab berdoxam administrations.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects will be eligible for enrollment in the study if they meet ONE criteria a, b or c in point 1 and ALL the criteria in points 2-9.

    1. Subjects must meet ONE of the criteria a, b or c below:
    a. For enrollment into Cohort A: Subjects with histologically confirmed advanced or metastatic non-uveal/non-mucosal melanoma or Merkel cell carcinoma (MCPyV positive and negative) who are not amenable to surgical cure and are candidates to receive single- or combined IOT alone (not to include cytotoxic chemotherapy) as first or second line treatment as per the local label/prescribing information at the physicians discretion.

    b. For enrollment into Cohort B: Subjects with histologically confirmed advanced or metastatic clear cell Renal Cell Carcinoma or Renal Cell Carcinoma with sarcomatoid features (regardless of subtype) as defined on pathologic examination by a component of clear cell or sarcomatoid, , who are not amenable to surgical cure and are candidates to receive single- or combined IOT alone or IOT in combination with VEGFR-directed or tyrosine kinase inhibitor (not to include cytotoxic chemotherapy) as first or second line treatment as per the local label/prescribing information at the physicians discretion.

    c. For enrollment into Cohort C: Subjects with histologically confirmed advanced or metastatic non-small cell lung cancer without non-smokers/driver mutations who are not amenable to surgical cure, and are candidates to receive single- or combined IOT alone (not to include cytotoxic chemotherapy) as first or second line treatment as per the label/prescribing information at the physicians discretion.

    i Patients with driver mutations that are expected to show significant benefit from first line checkpoint inhibiter treatment (such as KRAS G12C mutations) are eligible if all other Inclusion/Exclusion criteria are met

    Subjects must meet All of the criteria 2-9 below:
    2. At least 1 RECIST 1.1-measurable. non-irradiated, non-osseous (unless there is an associated measurable soft-tissue component) lesion documented on intravenous (IV) contrast-enhanced CT or MRI (per RECIST criteria 1.1) prior to first zirconium Zr 89 crefmirlimab berdoxam administration.
    3.Has had an adequate amount of time between their prior treatment/procedure and the 1st administration of zirconium Zr 89 crefmirlimab berdoxam as defined by:

    Radiation Washout Period:
    ≥2 weeks (≥4 weeks in the case of large-field abdominal radiation or treatment that includes liver or spleen in the radiation portal) and full recovery from any toxicities of radiation (as judged by the radiation oncologist). Patients undergoing palliative externalradiation within two weeks or during enrollment are eligible if the ALC is over 1000/μl.

    Chemotherapy or Targeted Therapy Washout Period:
    ≥3 weeks (≥2 weeks of 5-fluorouracial-based agents, folinate agents, and/or weekly paclitaxel; ≥2 weeks (or 5 half-lives, whichever is longer) for tyrosine kinase inhibitors; ≥6 weeks for nitrosoureas or mitomycin C).

    Surgery Washout Period:
    Fully recovered and free of complications.

    Adjuvant Therapy Washout Period:
    ≥6 months

    Vaccines Washout Period:
    ≥2 weeks from the last dose

    4. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and anticipated survival of at least 6 months.
    5. Meeting all clinical safety lab values per institution’s standard of care, or investigator’s discretion, for subjects receiving cancer treatment.
    6. Male or female age ≥18 years.
    7. Ability to understand the purposes and risks of the trial and has signed an Institutional Review Board approved informed consent form.
    8. Willingness and ability to comply with all protocol required procedures.
    9. Men and women of child-producing potential, must use highly effective contraceptive methods (methods that can achieve a failure rate of less than 1% per year when used consistently and correctly) as described in Section 6.9 of the protocol for the duration specified in Section 6.9 of the protocol or up to the time period according to the prescribing information for standard of care immuno-oncology therapy including Atezolizumab, whichever is longer.
    E.4Principal exclusion criteria
    Subjects will NOT be eligible for enrollment in the study if they meet ANY of the following criteria:

    1. Bone-only disease without a measurable soft tissue component on conventional imaging (MRI, PET, CT).
    2. Subjects with skin-only (cutaneous) lesions will be excluded from the tumor biopsy assessment.
    3. Serious nonmalignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise the safety of the subject or the protocol objectives.
    4. Subjects with splenic dysfunction or who are status post splenectomy. Post-splenectomy subjects who develop an accessory spleen with clinical and radiographic evidence of splenic function will be allowed with prior approval from the Sponsor.
    5. Corticosteroid therapy is prohibited if used for the treatment of inflammatory or autoimmune conditions. Patients with adrenal insufficiency from prior surgery or immunotherapy toxicity may be on standard chronic replacement doses of hydrocortisone that also require sporadic use of stress doses of steroid .
    6. Pregnant women or nursing mothers.
    E.5 End points
    E.5.1Primary end point(s)
    Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 from 3 (or up to 3) consecutive standard of care imaging assessments (CT and/or MRI) following onset of IOT treatment.

    Receiver operating characteristic (ROC) analysis will be performed to evaluate quantitative measurements from baseline and on-treatment scans as zirconium Zr 89 crefmirlimab berdoxam imaging biomarkers for predicting patient response to treatment. As a minimum the following measurements will be assessed as imaging biomarkers (‘the Biomarkers’).

    SUVmax in tumor/SUVmean aorta
    SUVpeak in tumor/SUVmean aorta
    SUVmean in tumor/SUVmean aorta
    CD8 tumor volume (volume of tumor tissues with increased CD8 uptake with SUV >40% SUVmax)

    This list may be extended to include additional measurements or composite biomarkers based on 2 or more measurements used in combination. Patient level biomarker scores will be calculated based on aggregates of lesion measurements, and these will be clearly defined in a separate document, the Image Analysis Methodology Plan.

    Patients with RECIST 1.1 responses of CR or PR will be considered responders, and patients with stable disease (SD) or PD will be considered non-responders.

    Qualitative interpretation methods will be evaluated for their ability to stratify patients into likely responders or likely non-responders. Estimates for sensitivity, specificity, positive predictive value (PPV) and NPV for predicting a patient response will be calculated and presented with 95% confidence intervals. Qualitative interpretation methods will be clearly defined in the Image Analysis Methodology Plan.
    E.5.1.1Timepoint(s) of evaluation of this end point
    In order to guide the implementation of the expansion cohort an interim analysis is planned once the 80th patient has been enrolled, dosed with the zirconium Zr 89 crefmirlimab berdoxam agent, and has provided 3 (or up to 3) consecutive SOC imaging assessments (CT and/or MRI) following onset of IOT treatment.
    E.5.2Secondary end point(s)
    Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI) following onset of IOT treatment.

    ROC analysis will be performed to evaluate the Biomarkers for prediction of lesion response to treatment. As with the primary endpoint, the baseline and on-treatment scans will be assessed separately as well as the difference in biomarker values between the 2 scans.

    Individual lesion response will be assessed on conventional imaging CT or MRI obtained for purposes of measuring a RECIST 1.1 response with subjects with at least one post treatment SOC CT and/or MRI scan. For ROC analysis, lesions with >30% decrease in the major axis will be considered responders and lesions with <30% decrease OR no change OR increase in the major axis will be considered non-responders.

    Qualitative interpretation methods will also be evaluated for their ability to stratify lesions into likely responders or likely non-responders. Estimates for sensitivity, specificity, PPV and NPV for predicting a lesion response will be presented with 95% confidence intervals. Qualitative interpretation methods will be clearly defined in the Image Analysis Methodology Plan.

    The safety and tolerability of repeat doses of zirconium Zr 89 crefmirlimab berdoxam:

    Incidence and severity of infusion/slow bolus injection reactions occurring during or shortly after administration of the IP.
    Incidence and severity of TEAEs probably or definitely related to zirconium Zr 89 crefmirlimab berdoxam, coded per CTCAE v5.0 TEAEs.
    Incidence of withdrawals from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam-related AEs.
    Laboratory results and clinically significant changes in laboratory test results over the study course.
    12-lead ECG parameters and change in ECG results related to zirconium Zr 89 crefmirlimab berdoxam.
    ADAs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    In order to guide the implementation of the expansion cohort an interim analysis is planned once the 80th patient has been enrolled, dosed with the zirconium Zr 89 crefmirlimab berdoxam agent, and has provided 3 (or up to 3) consecutive SOC imaging assessments (CT and/or MRI) following onset of IOT treatment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    United States
    Switzerland
    Belgium
    Italy
    Netherlands
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2025-01-10
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