Positron-Emission TomographyPhase 2iCorrelateNCT03802123
⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for PET/CT in Patients With Metastatic Solid Tumors
A Phase 2 study testing ⁸⁹Zr-Df-IAB22M2C in people with Positron-Emission Tomography and Metastatic Solid Tumors, run by ImaginAb, Inc. at 15 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety of repeat doses ⁸⁹Zr-Df-IAB22M2C and to establish the relationship between ⁸⁹Zr-Df-IAB22M2C PET/CT lesion uptake with CD8+ cells by immunohistochemical staining in patients with selected advanced and metastatic solid malignancies who are scheduled to receive standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Positron-Emission Tomography, Metastatic Solid Tumors
- What is being tested?
- ⁸⁹Zr-Df-IAB22M2C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 15 sitesUnited States
- Study dates
- 18 Dec 2018to 18 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be eligible for enrollment in the study only if they meet ALL of the following criteria:
- 1. Patients with advanced or metastatic Melanoma, Non-Small Cell Lung Cancer, Renal Cell Carcinoma or Squamous Cell Carcinoma of the Head and Neck with at least one non-radiated lesion, who are scheduled to begin standard of care immunotherapy.
- • At least 1 non radiated measurable lesion documented on CT/, MRI (per RECIST criteria 1.1) or are FDG avid on FDG-PET within 45 days prior to first 89Zr-Df-IAB22M2C (CD8 PET Tracer) infusion.
- At least 1 non-cutaneous lesion that is accessible, per investigator's assessment, and eligible for biopsy. If only a single RECIST measurable lesion is present, investigator to determine if the tumor biopsy could interfere with RECIST assessments of response.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Meeting all clinical safety lab values per institution's standard of care, or Investigator's discretion, for patients receiving cancer treatment.
Show all 10Show fewer
- Age ≥ 18 years.
- Ability to understand the purposes and risks of the trial and has signed an IRB-approved informed consent form.
- Willingness and ability to comply with all protocol required procedures.
- For men and women of child-producing potential, use of effective double barrier contraceptive methods during the study, up to 30 days after the last administration of the investigational product.
Who cannot join
- Subjects will NOT be eligible for enrollment in the study if they meet ANY of the following criteria:
- Serious nonmalignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
- Patients with a single RECIST measurable lesion, biopsy of which, per investigator's assessment, is likely to interfere with RECIST assessments of response.
- Patients who have any splenic disorders, or had splenectomy, that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
- Pregnant women or nursing mothers.
- 5. Life expectancy < 6 months
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Alabama-Birmingham Hospital
Birmingham, Alabama, 35294
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02215
Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
CARTI Cancer Center
Little Rock, Arkansas, 72205
Keck Hospital of USC
Los Angeles, California, 90033
LAC + USC Medical Center
Los Angeles, California, 90033
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
University of Pennsylvania, Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
John Wayne Cancer Institute at Providence Saint John's Health Center
Santa Monica, California, 90404
Seattle Cancer Care Alliance/ University of Washington
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase II, Open Label, Multi-Dose Study of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for Positron Emission Tomography (PET/CT) in Patients With Selected Advanced or Metastatic Solid Malignancies Who Are Scheduled to Receive Standard-of-Care Immunotherapy Only, As Single Agent or in Combination
The purpose of this study is to evaluate the safety of repeat doses ⁸⁹Zr-Df-IAB22M2C and to establish the relationship between ⁸⁹Zr-Df-IAB22M2C PET/CT lesion uptake with CD8+ cells by immunohistochemical staining in patients with selected advanced and metastatic solid malignancies who are scheduled to receive standard of care immunotherapy. The study will also evaluate uptake of ⁸⁹Zr-Df-IAB22M2C by PET/CT in patients at baseline and on immunotherapy.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Up to 1 week prior to initiation of immunotherapy, patients will receive an injection of ⁸⁹Zr-Df-IAB22M2C (1.0 mCi) and will undergo PET/CT scanning to determine baseline uptake of ⁸⁹Zr-Df-IAB22M2C in tumor lesions and reference tissues. Patients will receive an additional injection of ⁸⁹Zr-Df-IAB22M2C (1.0 mCi) and PET/CT scan 4-6 weeks after starting immunotherapy (on-therapy) to evaluate uptake of ⁸⁹Zr-Df-IAB22M2C in tumor lesions and reference tissues, and to assess potential changes in uptake of ⁸⁹Zr-Df-IAB22M2C compared to the baseline scan.
- Being tested
- ⁸⁹Zr-Df-IAB22M2C
- Keywords
- PET/CT, ⁸⁹Zr-Df-IAB22M2C, CD8, Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
⁸⁹Zr-Df-IAB22M2CDrug
⁸⁹Zr-Df-IAB22M2C CD8 T cell tracer for Positron Emission Tomography (PET)
| Study group | Role | What they receive |
|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Experimental | A dose of 3 mCi (±20%) of ⁸⁹Zr-Df-IAB22M2C between 0.5 mg to 1.5 mg of API will be administered intravenously over 5-10 minutes, within one week prior to the onset of immunotherapy, and 5 to 6 weeks after start of IOT. Receives: Drug: ⁸⁹Zr-Df-IAB22M2C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of ⁸⁹Zr-Df-IAB22M2C Uptake in Biopsied Tumors With CD8+ Cell Measurement by Immunohistochemistry (IHC)
Analyze ⁸⁹Zr-Df-IAB22M2C uptake in biopsied tumors as determined by SUV-based quantitative measures (SUVmax, SUVpeak, SUVmean, CD8 tumor volume, and tumor:reference tissue ratio) with CD8+ cell measurement determined by IHC from biopsy samples.
Measured: Baseline to 4-5 weeks after the start of immunotherapy
Number of Participants With Adverse Events
Number of participants who experienced any treatment emergent adverse events
Measured: Up to 12 weeks
Participants With Signs and Symptoms of Infusion Reactions
Number of participants with reported signs or symptoms of infusion reactions
Measured: Up to 12 weeks
Change in WBC Absolute Counts
WBC absolute counts
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in Hematocrit (%) Laboratory Values
hematocrit (%) laboratory values
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline
hemoglobin (g/dL) laboratory values compared with baseline results.
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in Platelet Count Laboratory Values Compared With Baseline
platelet count laboratory values compared with baseline results.
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in WBC Count Laboratory Values Compared With Baseline
WBC count laboratory values compared with baseline results.
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in RBC Count Laboratory Values Compared With Baseline
RBC count laboratory values compared with baseline results.
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline
blood glucose (mg/dL) laboratory values compared with baseline results.
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in Chloride Laboratory Values Compared With Baseline
chloride laboratory values compared with baseline results.
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in Potassium Laboratory Values Compared With Baseline
Potassium laboratory values compared with baseline results.
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in Sodium Laboratory Values Compared With Baseline
sodium laboratory values compared with baseline results.
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline
serum creatinine (mg/dL) laboratory values compared with baseline results.
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in GGT (U/L) Laboratory Values Compared With Baseline
GGT (U/L) laboratory values compared with baseline results.
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in BUN (mg/dL) Laboratory Values Compared With Baseline
BUN (mg/dL) laboratory values compared with baseline results.
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in LDH (U/L) Laboratory Values Comapared With Baseline
LDH (U/L) laboratory values compared with baseline results.
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Total Bilirubin (mg/dL) Laboratory Values
Total bilirubin (mg/dL) laboratory values compared with baseline results.
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
ALP Laboratory Values
Change/shifts in ALP (U/L) laboratory values compared with baseline results.
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
ALT Laboratory Values
Change/shifts in ALT (U/L) laboratory values compared with baseline results.
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
AST Laboratory Values
Change/shifts in AST (U/L) laboratory values compared with baseline results.
Measured: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
PR Interval Assessed by 12-Lead Electrocardiogram
PR interval reported in milliseconds (msecs)
Measured: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)
Diastolic Blood Pressure
Diastolic Blood Pressure
Measured: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
Evaluation of Heart Rate (Beats Per Minute)
Changes/shifts in heart rate
Measured: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
Evaluation of Respiration Rate
Changes/shifts in respiration rate
Measured: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
Evaluation of Temperature
Changes/shifts in temperature
Measured: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
QRS Interval Assessed by 12-Lead Electrocardiogram
QRS Interval reported in milliseconds (msec)
Measured: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)
QT Interval Assessed by 12-Lead Electrocardiogram
QT interval reported in milliseconds (msec)
Measured: Baseline, Visit 2 (Day1), Visit 5 (Day 30-51)
QTc Interval Assessed by 12-Lead Electrocardiogram
QTc interval reported in milliseconds (msecs)
Measured: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)
Secondary outcomes (3)
Assessment of Baseline and On-treatment ⁸⁹Zr-Df-IAB22M2C Uptake and Distribution in Lymphoid Organs, and Measurement of Change Between the Paired Observations
Assessment of Baseline and On-treatment ⁸⁹Zr-Df-IAB22M2C uptake and distribution in tumors and lymphoid organs, and measurement of change between the paired observations as determined by:
-SUVs in reference tissues
Measured: 5 weeks
Measurement of Change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake in Biopsied Tumors as Determined by SUV-based Quantitative Analysis
Measurement of change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) uptake in biopsied tumors as determined by SUV-based quantitative analysis (e.g. SUVmax, SUVpeak, SUVmean)
Measured: 7 weeks
Description of Biodistribution Patterns of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) on PETbaseline and PETTx and Any Changes in Biodistribution Between Baseline and On-Treatment.
Description of biodistribution patterns of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) on PETbaseline and PETTx and any changes in biodistribution between baseline and On-Treatment.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start18 Dec 2018
- Primary completion19 Oct 2021
- Study completion18 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Positron-Emission TomographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImaginAb, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Korn, MD, PhD, Study director, ImaginAb, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802123
- Sponsor's protocol ID
- IAB-CD8-201
- Acronym
- iCorrelate
- Status last verified
- Jun 2024
- First submitted
- 19 Dec 2018
- Last updated
- 9 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Multi-Dose Study of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for Positron Emission Tomography (PET/CT) in Patients With Selected Advanced or Metastatic Solid Malignancies Who Are Scheduled to Receive Standard-of-Care Immunotherapy Only, As Single Agent or in Combination
- ClinicalTrials.gov ID
- NCT03802123
- Acronym / sponsor ID
- iCorrelate / IAB-CD8-201
- Keywords
- PET/CT, ⁸⁹Zr-Df-IAB22M2C, CD8, Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- ImaginAb, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Posted 9 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of repeat doses ⁸⁹Zr-Df-IAB22M2C and to establish the relationship between ⁸⁹Zr-Df-IAB22M2C PET/CT lesion uptake with CD8+ cells by immunohistochemical staining in patients with selected advanced and metastatic solid malignancies who are scheduled to receive standard of care immunotherapy. The study will also evaluate uptake of ⁸⁹Zr-Df-IAB22M2C by PET/CT in patients at baseline and on immunotherapy.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Up to 1 week prior to initiation of immunotherapy, patients will receive an injection of ⁸⁹Zr-Df-IAB22M2C (1.0 mCi) and will undergo PET/CT scanning to determine baseline uptake of ⁸⁹Zr-Df-IAB22M2C in tumor lesions and reference tissues. Patients will receive an additional injection of ⁸⁹Zr-Df-IAB22M2C (1.0 mCi) and PET/CT scan 4-6 weeks after starting immunotherapy (on-therapy) to evaluate uptake of ⁸⁹Zr-Df-IAB22M2C in tumor lesions and reference tissues, and to assess potential changes in uptake of ⁸⁹Zr-Df-IAB22M2C compared to the baseline scan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Experimental | Drug: ⁸⁹Zr-Df-IAB22M2CA dose of 3 mCi (±20%) of ⁸⁹Zr-Df-IAB22M2C between 0.5 mg to 1.5 mg of API will be administered intravenously over 5-10 minutes, within one week prior to the onset of immunotherapy, and 5 to 6 weeks after start of IOT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants will be eligible for enrollment in the study only if they meet ALL of the following criteria:
- 1. Patients with advanced or metastatic Melanoma, Non-Small Cell Lung Cancer, Renal Cell Carcinoma or Squamous Cell Carcinoma of the Head and Neck with at least one non-radiated lesion, who are scheduled to begin standard of care immunotherapy.
- • At least 1 non radiated measurable lesion documented on CT/, MRI (per RECIST criteria 1.1) or are FDG avid on FDG-PET within 45 days prior to first 89Zr-Df-IAB22M2C (CD8 PET Tracer) infusion.
- At least 1 non-cutaneous lesion that is accessible, per investigator's assessment, and eligible for biopsy. If only a single RECIST measurable lesion is present, investigator to determine if the tumor biopsy could interfere with RECIST assessments of response.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Key exclusion criteria (6 listed)
- Subjects will NOT be eligible for enrollment in the study if they meet ANY of the following criteria:
- Serious nonmalignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
- Patients with a single RECIST measurable lesion, biopsy of which, per investigator's assessment, is likely to interfere with RECIST assessments of response.
- Patients who have any splenic disorders, or had splenectomy, that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
- Pregnant women or nursing mothers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C⁸⁹Zr-Df-IAB22M2C CD8 T cell tracer for Positron Emission Tomography (PET) | Drug | ⁸⁹Zr-Df-IAB22M2C Infusion |
Primary outcome
Correlation of ⁸⁹Zr-Df-IAB22M2C Uptake in Biopsied Tumors With CD8+ Cell Measurement by Immunohistochemistry (IHC)
Time frame: Baseline to 4-5 weeks after the start of immunotherapy
Analyze ⁸⁹Zr-Df-IAB22M2C uptake in biopsied tumors as determined by SUV-based quantitative measures (SUVmax, SUVpeak, SUVmean, CD8 tumor volume, and tumor:reference tissue ratio) with CD8+ cell measurement determined by IHC from biopsy samples.
Number of Participants With Adverse Events
Time frame: Up to 12 weeks
Number of participants who experienced any treatment emergent adverse events
Participants With Signs and Symptoms of Infusion Reactions
Time frame: Up to 12 weeks
Number of participants with reported signs or symptoms of infusion reactions
Change in WBC Absolute Counts
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
WBC absolute counts
Changes in Hematocrit (%) Laboratory Values
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
hematocrit (%) laboratory values
Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
hemoglobin (g/dL) laboratory values compared with baseline results.
Changes in Platelet Count Laboratory Values Compared With Baseline
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
platelet count laboratory values compared with baseline results.
Changes in WBC Count Laboratory Values Compared With Baseline
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
WBC count laboratory values compared with baseline results.
Changes in RBC Count Laboratory Values Compared With Baseline
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
RBC count laboratory values compared with baseline results.
Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
blood glucose (mg/dL) laboratory values compared with baseline results.
Changes in Chloride Laboratory Values Compared With Baseline
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
chloride laboratory values compared with baseline results.
Changes in Potassium Laboratory Values Compared With Baseline
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Potassium laboratory values compared with baseline results.
Changes in Sodium Laboratory Values Compared With Baseline
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
sodium laboratory values compared with baseline results.
Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
serum creatinine (mg/dL) laboratory values compared with baseline results.
Changes in GGT (U/L) Laboratory Values Compared With Baseline
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
GGT (U/L) laboratory values compared with baseline results.
Changes in BUN (mg/dL) Laboratory Values Compared With Baseline
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
BUN (mg/dL) laboratory values compared with baseline results.
Changes in LDH (U/L) Laboratory Values Comapared With Baseline
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
LDH (U/L) laboratory values compared with baseline results.
Total Bilirubin (mg/dL) Laboratory Values
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Total bilirubin (mg/dL) laboratory values compared with baseline results.
ALP Laboratory Values
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Change/shifts in ALP (U/L) laboratory values compared with baseline results.
ALT Laboratory Values
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Change/shifts in ALT (U/L) laboratory values compared with baseline results.
AST Laboratory Values
Time frame: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Change/shifts in AST (U/L) laboratory values compared with baseline results.
PR Interval Assessed by 12-Lead Electrocardiogram
Time frame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)
PR interval reported in milliseconds (msecs)
Diastolic Blood Pressure
Time frame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
Diastolic Blood Pressure
Evaluation of Heart Rate (Beats Per Minute)
Time frame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
Changes/shifts in heart rate
Evaluation of Respiration Rate
Time frame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
Changes/shifts in respiration rate
Evaluation of Temperature
Time frame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
Changes/shifts in temperature
QRS Interval Assessed by 12-Lead Electrocardiogram
Time frame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)
QRS Interval reported in milliseconds (msec)
QT Interval Assessed by 12-Lead Electrocardiogram
Time frame: Baseline, Visit 2 (Day1), Visit 5 (Day 30-51)
QT interval reported in milliseconds (msec)
QTc Interval Assessed by 12-Lead Electrocardiogram
Time frame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)
QTc interval reported in milliseconds (msecs)
3 secondary outcomes
Assessment of Baseline and On-treatment ⁸⁹Zr-Df-IAB22M2C Uptake and Distribution in Lymphoid Organs, and Measurement of Change Between the Paired Observations
Time frame: 5 weeks
Measurement of Change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake in Biopsied Tumors as Determined by SUV-based Quantitative Analysis
Time frame: 7 weeks
Description of Biodistribution Patterns of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) on PETbaseline and PETTx and Any Changes in Biodistribution Between Baseline and On-Treatment.
Time frame: 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Korn, MD, PhD study director
ImaginAb, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ⁸⁹Zr-Df-IAB22M2C in people with Positron-Emission Tomography and Metastatic Solid Tumors, run by ImaginAb, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of ⁸⁹Zr-Df-IAB22M2C Uptake in Biopsied Tumors With CD8+ Cell Measurement by Immunohistochemistry (IHC) (time frame: Baseline to 4-5 weeks after the start of immunotherapy). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.