Positron-Emission TomographyPhase 1NCT03107663
⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's Lymphoma
A Phase 1 study testing ⁸⁹Zr-Df-IAB22M2C Infusion in people with Positron-Emission Tomography and Immunomodulation, run by ImaginAb, Inc. at 3 sites in United States.
Trial summary
To determine the safety and feasibility of 89Zr-Df-IAB22M2C as an immunoPET tracer; determine the best time window and protein dose for imaging; determine the pharmacokinetic (PK) and biodistribution of the probe; and to determine imaging parameters for optimal lymphoid and tumor visualization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Positron-Emission Tomography, Immunomodulation, Metastatic Solid Malignancies
- What is being tested?
- ⁸⁹Zr-Df-IAB22M2C Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Jun 2017to 16 Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients with selected solid malignancies (NSCLC, SCLC, SqCCHN, melanoma, merkel cell tumor, renal, bladder, hepatocellular, triple negative breast, or gastroesophageal cancer) or Hodgkin's lymphoma
- At least 1 measurable lesion documented on CT/MRI (RECIST criteria 1.1)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix B: ECOG Scoring)
- Age ≥ 18 years
- Ability to understand the purposes and risks of the trial and has signed a IRB-approved informed consent form
- Willingness and ability to comply with all protocol required procedures
- For men and women of child-bearing potential, use of effective contraceptive methods during the study
Who cannot join
- Patients meeting any of the following criteria will not be eligible for study entry:
- Known infection with human immunodeficiency virus (HIV)
- Serious nonmalignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives
- Patients who have had splenectomy.
- Patients who have any splenic disorders that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
- Patients who are currently receiving any other investigational agent
Show all 12Show fewer
- Pregnant women or nursing mothers
- Hepatic laboratory values:
- Bilirubin > 1.5 x ULN (institutional upper limits of normal)
- Albumin < 2 g/dL
- Other local safety laboratory test results (clinical chemistry and hematology) are determined to be exclusionary by the Investigator.
- Known sensitivity to glutamic acid or glutamate.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Honor Health and Imaging Endpoints
Scottsdale, Arizona, 85258
About this study
Official title: A Phase I Study of Positron Emission Tomography (PET/CT) With ⁸⁹Zr-Df-IAB22M2C in Patients With Selected Solid Malignancies (Non Small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC), Squamous Cell Carcinoma Head and Neck (SqCCHN), Melanoma, Merkel Cell Tumor, Renal, Bladder, Hepatocellular, Triple Negative Breast, or Gastroesophageal Cancer) or Hodgkin's Lymphoma
To determine the safety and feasibility of 89Zr-Df-IAB22M2C as an immunoPET tracer; determine the best time window and protein dose for imaging; determine the pharmacokinetic (PK) and biodistribution of the probe; and to determine imaging parameters for optimal lymphoid and tumor visualization.
Read the detailed description
This is a phase I study of positron emission tomography (PET/CT) with ⁸⁹Zr-Df-IAB22M2C in patients with selected solid malignancies (NSCLC, SCLC, SqCCHN, melanoma, merkel cell tumor, renal, bladder, hepatocellular, triple negative breast, or gastroesophageal cancer) or Hodgkin's lymphoma. Up to 24 subjects are planned to be enrolled in this clinical study.
This phase 1 study is a dose escalation study of ⁸⁹Zr-Df-IAB22M2C to evaluate safety, tolerability, optimal time window and protein dose for imaging, biodistribution, radiation dosimetry, as well as the ability of ⁸⁹Zr-Df-IAB22M2C to detect CD8+ expressing T cells. The investigational imaging agent to be administered in this study will be 3.0 (±20%) mCi dose of ⁸⁹Zr-Df-IAB22M2C injected intravenously. Up to six cohorts of up to 6 patients each will be studied sequentially with dose escalation at 0.2 mg, 0.5 mg, 1.0 mg, 1.5 mg, 5.0 mg, and 10.0 mg total protein doses followed by an optimal dose expansion cohort. Safety as well as lymphoid visualization (LV) on imaging (i.e. signal in tumor and lymphoid organs including spleen, lymph nodes and bone marrow) will be evaluated to drive dose escalation/de-escalation.
At least 2 weeks will separate the ⁸⁹Zr-Df-IAB22M2C administration in the first patient and subsequent patients of each dose cohort to provide an opportunity to detect any acute reaction to the study drug and any adverse events. Tracer administration for subsequent patients in each cohort will be separated by a minimum of 24 hours
Each patient will undergo five (5) post infusion PET/CT scans ( 1 - 2 hours, 6-8 hrs (optional), 24 ± 4 hours, 48 ± 4 hours and 92 - 144 hours).
Pharmacokinetic blood samples will be drawn at the following timepoints: pre-infusion; then post-infusion at 5-10 min, 30 (+/-10) min, 60 (+/- 10) min, 120 (+/- 10) min, 240 (+/- 10) min, 350-490 (+/- 10) min (optional), 24 hrs (visit 3), 48 hrs (visit 4), 92-144 hrs (visit 5). The imaging data collected across the dosing cohort and time series of PET/CT scans will assess biodistribution, dosimetry, and be used to recommend a protein dose and an optimal time window for imaging in future studies
- Conditions
- Positron-Emission Tomography, Immunomodulation, Metastatic Solid Malignancies, Hodgkin Lymphoma
- Being tested
- ⁸⁹Zr-Df-IAB22M2C Infusion
- Keywords
- PET/CT, Imaging, ⁸⁹Zr-Df-IAB22M2C, CD8 + T Cells, Standard of Care
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
⁸⁹Zr-Df-IAB22M2C InfusionDrug
A single dose of 3.0 (±20%) mCi of ⁸⁹Zr-Df-IAB22M2C (with 0.2 mg, 0.5 mg, 1.0mg, 1.5 mg, 5.0 mg, or 10.0 mg of protein) will be administered intravenously over 5-10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Experimental | 3.0 (±20%) mCi of ⁸⁹Zr-Df-IAB22M2C (with 0.2 mg, 0.5 mg, 1.0mg, 1.5 mg, 5.0 mg, or 10.0 mg of protein) will be administered intravenously over 5-10 minutes Receives: Drug: ⁸⁹Zr-Df-IAB22M2C Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ⁸⁹Zr-Df-IAB22M2C assessed by local and systemic signs and symptoms of infusion reactions,incidence of adverse events,changes in laboratory test results,dose limiting toxicities,vital signs and 12-lead electrocardiogram findings
Measured: From infusion of ⁸⁹Zr-Df-IAB22M2C up to 12 weeks
Secondary outcomes (4)
Evaluate imaging time window with ⁸⁹Zr-Df-IAB22M2C
Measured: From infusion of ⁸⁹Zr-Df-IAB22M2C through up to Day 6
Evaluate protein dose for imaging with ⁸⁹Zr-Df-IAB22M2C
Measured: From infusion of ⁸⁹Zr-Df-IAB22M2C through up to Day 6
Evaluate the radioactive pharmacokinetics of ⁸⁹Zr-Df-IAB22M2C by determining the time-activity curves for serum (% injected dose/liter), AUC, clearance, volume of distribution, Tmax and Cmax.
The data from the actual concentration and the parameters will be summarized descriptively and also presented as subject specific listings.
Measured: From infusion of ⁸⁹Zr-Df-IAB22M2C through up to Day 6
Evaluate the dosimetry of a single dose of ⁸⁹Zr-Df-IAB22M2C
Dosimetry will be determined from the ⁸⁹Zr-Df-IAB22M2C PET/CT scans obtained during the course of this study at 1-2 hours, 6-8 hours (optional), 24 (± 4 hours), 48 (± 4 hours) hours and 92-144 hours post infusion in patients at the optimal dosing cohort. Regions of interest will be drawn at each PET/CT time point to capture target and major organ uptakes. Once all five PET/CT scans are analyzed, the biologic clearance will be evaluated from the "dynamic" sequence of the scans and the final estimated radiation dose calculated using the clearance seen in the images. The data for dosimetry also comes from Imaging Endpoints. Patterns of radiotracer uptake and estimates of semi-quantitative measurements, using typical SUV (Standardized uptake value) estimates (SUV max; SUV peak; SUV mean) will be presented. The data will be summarized descriptively and will also be presented as subject specific listings.
Measured: From infusion of ⁸⁹Zr-Df-IAB22M2C through up to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start19 Jun 2017
- Primary completion16 Aug 2018
- Study completion16 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImaginAb, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107663
- Sponsor's protocol ID
- 2015-22M2C-01.02
- Status last verified
- Sep 2018
- First submitted
- 16 Jan 2017
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farwell MD, Gamache RF, Babazada H, Hellmann MD, Harding JJ, Korn R, Mascioni A, Le W, Wilson I, Gordon MS, Wu AM, Ulaner GA, Wolchok JD, Postow MA, Pandit-Taskar N. CD8-Targeted PET Imaging of Tumor-Infiltrating T Cells in Patients with Cancer: A Phase I First-in-Humans Study of 89Zr-Df-IAB22M2C, a Radiolabeled Anti-CD8 Minibody. J Nucl Med. 2022 May;63(5):720-726. doi: 10.2967/jnumed.121.262485. Epub 2021 Aug 19.
PubMed 34413145
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Positron Emission Tomography (PET/CT) With ⁸⁹Zr-Df-IAB22M2C in Patients With Selected Solid Malignancies (Non Small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC), Squamous Cell Carcinoma Head and Neck (SqCCHN), Melanoma, Merkel Cell Tumor, Renal, Bladder, Hepatocellular, Triple Negative Breast, or Gastroesophageal Cancer) or Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT03107663
- Acronym / sponsor ID
- 2015-22M2C-01.02
- Conditions
- Positron-Emission Tomography, Immunomodulation, Metastatic Solid Malignancies, Hodgkin Lymphoma
- Keywords
- PET/CT, Imaging, ⁸⁹Zr-Df-IAB22M2C, CD8 + T Cells, Standard of Care
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- ImaginAb, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 16 Aug 2018 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and feasibility of 89Zr-Df-IAB22M2C as an immunoPET tracer; determine the best time window and protein dose for imaging; determine the pharmacokinetic (PK) and biodistribution of the probe; and to determine imaging parameters for optimal lymphoid and tumor visualization.
Detailed description
This is a phase I study of positron emission tomography (PET/CT) with ⁸⁹Zr-Df-IAB22M2C in patients with selected solid malignancies (NSCLC, SCLC, SqCCHN, melanoma, merkel cell tumor, renal, bladder, hepatocellular, triple negative breast, or gastroesophageal cancer) or Hodgkin's lymphoma. Up to 24 subjects are planned to be enrolled in this clinical study.
This phase 1 study is a dose escalation study of ⁸⁹Zr-Df-IAB22M2C to evaluate safety, tolerability, optimal time window and protein dose for imaging, biodistribution, radiation dosimetry, as well as the ability of ⁸⁹Zr-Df-IAB22M2C to detect CD8+ expressing T cells. The investigational imaging agent to be administered in this study will be 3.0 (±20%) mCi dose of ⁸⁹Zr-Df-IAB22M2C injected intravenously. Up to six cohorts of up to 6 patients each will be studied sequentially with dose escalation at 0.2 mg, 0.5 mg, 1.0 mg, 1.5 mg, 5.0 mg, and 10.0 mg total protein doses followed by an optimal dose expansion cohort. Safety as well as lymphoid visualization (LV) on imaging (i.e. signal in tumor and lymphoid organs including spleen, lymph nodes and bone marrow) will be evaluated to drive dose escalation/de-escalation.
At least 2 weeks will separate the ⁸⁹Zr-Df-IAB22M2C administration in the first patient and subsequent patients of each dose cohort to provide an opportunity to detect any acute reaction to the study drug and any adverse events. Tracer administration for subsequent patients in each cohort will be separated by a minimum of 24 hours
Each patient will undergo five (5) post infusion PET/CT scans ( 1 - 2 hours, 6-8 hrs (optional), 24 ± 4 hours, 48 ± 4 hours and 92 - 144 hours).
Pharmacokinetic blood samples will be drawn at the following timepoints: pre-infusion; then post-infusion at 5-10 min, 30 (+/-10) min, 60 (+/- 10) min, 120 (+/- 10) min, 240 (+/- 10) min, 350-490 (+/- 10) min (optional), 24 hrs (visit 3), 48 hrs (visit 4), 92-144 hrs (visit 5). The imaging data collected across the dosing cohort and time series of PET/CT scans will assess biodistribution, dosimetry, and be used to recommend a protein dose and an optimal time window for imaging in future studies
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-IAB22M2C Infusion3.0 (±20%) mCi of ⁸⁹Zr-Df-IAB22M2C (with 0.2 mg, 0.5 mg, 1.0mg, 1.5 mg, 5.0 mg, or 10.0 mg of protein) will be administered intravenously over 5-10 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with selected solid malignancies (NSCLC, SCLC, SqCCHN, melanoma, merkel cell tumor, renal, bladder, hepatocellular, triple negative breast, or gastroesophageal cancer) or Hodgkin's lymphoma
- At least 1 measurable lesion documented on CT/MRI (RECIST criteria 1.1)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix B: ECOG Scoring)
- Age ≥ 18 years
- Ability to understand the purposes and risks of the trial and has signed a IRB-approved informed consent form
Key exclusion criteria (12 listed)
- Known infection with human immunodeficiency virus (HIV)
- Serious nonmalignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives
- Patients who have had splenectomy.
- Patients who have any splenic disorders that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
- Patients who are currently receiving any other investigational agent
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-IAB22M2C InfusionA single dose of 3.0 (±20%) mCi of ⁸⁹Zr-Df-IAB22M2C (with 0.2 mg, 0.5 mg, 1.0mg, 1.5 mg, 5.0 mg, or 10.0 mg of protein) will be administered intravenously over 5-10 minutes. | Drug | ⁸⁹Zr-Df-IAB22M2C Infusion |
Primary outcome
Safety and tolerability of ⁸⁹Zr-Df-IAB22M2C assessed by local and systemic signs and symptoms of infusion reactions,incidence of adverse events,changes in laboratory test results,dose limiting toxicities,vital signs and 12-lead electrocardiogram findings
Time frame: From infusion of ⁸⁹Zr-Df-IAB22M2C up to 12 weeks
4 secondary outcomes
Evaluate imaging time window with ⁸⁹Zr-Df-IAB22M2C
Time frame: From infusion of ⁸⁹Zr-Df-IAB22M2C through up to Day 6
Evaluate protein dose for imaging with ⁸⁹Zr-Df-IAB22M2C
Time frame: From infusion of ⁸⁹Zr-Df-IAB22M2C through up to Day 6
Evaluate the radioactive pharmacokinetics of ⁸⁹Zr-Df-IAB22M2C by determining the time-activity curves for serum (% injected dose/liter), AUC, clearance, volume of distribution, Tmax and Cmax.
Time frame: From infusion of ⁸⁹Zr-Df-IAB22M2C through up to Day 6
Evaluate the dosimetry of a single dose of ⁸⁹Zr-Df-IAB22M2C
Time frame: From infusion of ⁸⁹Zr-Df-IAB22M2C through up to Day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Derived from this study: PubMed 34413145Farwell MD, Gamache RF, Babazada H, Hellmann MD, Harding JJ, Korn R, Mascioni A, Le W, Wilson I, Gordon MS, Wu AM, Ulaner GA, Wolchok JD, Postow MA, Pandit-Taskar N. CD8-Targeted PET Imaging of Tumor-Infiltrating T Cells in Patients with Cancer: A Phase I First-in-Humans Study of 89Zr-Df-IAB22M2C, a Radiolabeled Anti-CD8 Minibody. J Nucl Med. 2022 May;63(5):720-726. doi: 10.2967/jnumed.121.262485. Epub 2021 Aug 19.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ⁸⁹Zr-Df-IAB22M2C Infusion in people with Positron-Emission Tomography and Immunomodulation, run by ImaginAb, Inc. at 3 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 7 inclusion and 12 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 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability of ⁸⁹Zr-Df-IAB22M2C assessed by local and systemic signs and symptoms of infusion reactions,incidence of adverse events,changes in laboratory test results,dose limiting toxicities,vital signs and 12-lead electrocardiogram findings (time frame: From infusion of ⁸⁹Zr-Df-IAB22M2C up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03107663, which also lists 1 linked publication.
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 18 Sep 2018; AzTrials last refreshed its copy on 6 Nov 2026.