Phase 2
Completed N=52
⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for PET/CT in Patients With Metastatic Solid Tumors
Positron-Emission Tomography · Solid Tumors
Source: ClinicalTrials.gov NCT03802123 ↗
Enrolled (actual)
52
Serious AEs
21.2%
Results posted
Jul 2024
Primary outcomePrimary: Correlation of ⁸⁹Zr-Df-IAB22M2C Uptake in Biopsied Tumors With CD8+ Cell Measurement by Immunohistochemistry (IHC) — 0.3902; 0.7848 r
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 of care immunotherapy. The study will also evaluate uptake of ⁸⁹Zr-Df-IAB22M2C by PET/CT in patients at baseline and on immunotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation of ⁸⁹Zr-Df-IAB22M2C Uptake in Biopsied Tumors With CD8+ Cell Measurement by Immunohistochemistry (IHC) |
0.3902; 0.7848 | — |
| PRIMARY Number of Participants With Adverse Events |
40 | — |
| PRIMARY Participants With Signs and Symptoms of Infusion Reactions |
— | — |
| PRIMARY Change in WBC Absolute Counts |
7.6; 7.7; 6.3; 6.2; 6.4; 6.4 | — |
| PRIMARY Changes in Hematocrit (%) Laboratory Values |
38.2; 37.7; 37.2; 38.7; 36.6; 36.5 | — |
| PRIMARY Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline |
12.5; 12.4; 12.1; 12.8; 12.1; 12.1 | — |
| PRIMARY Changes in Platelet Count Laboratory Values Compared With Baseline |
270.1; 224.5; 227.2; 227.0; 249.7; 242.1 | — |
| PRIMARY Changes in WBC Count Laboratory Values Compared With Baseline |
7.6; 7.7; 6.3; 6.2; 6.4; 6.4 | — |
| PRIMARY Changes in RBC Count Laboratory Values Compared With Baseline |
4.3; 4.1; 4.2; 4.3; 4.1; 4.1 | — |
| PRIMARY Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline |
115.986; 119.114; 115.534; 295.466; 108.651; 113.208 | — |
| PRIMARY Changes in Chloride Laboratory Values Compared With Baseline |
102.255; 102.769; 102.364; 103.900; 103.059; 102.419 | — |
| PRIMARY Changes in Potassium Laboratory Values Compared With Baseline |
4.314; 4.038; 4.223; 4.080; 4.333; 4.233 | — |
| PRIMARY Changes in Sodium Laboratory Values Compared With Baseline |
137.510; 137.154; 137.227; 138.000; 137.556; 137.326 | — |
| PRIMARY Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline |
0.930; 0.958; 0.934; 0.961; 0.834; 0.935 | — |
| PRIMARY Changes in GGT (U/L) Laboratory Values Compared With Baseline |
36.957; 60.500; 56.333; 77.700; 17.333; 88.200 | — |
| PRIMARY Changes in BUN (mg/dL) Laboratory Values Compared With Baseline |
16.720; 15.417; 17.140; 17.778; 13.353; 17.119 | — |
| PRIMARY Changes in LDH (U/L) Laboratory Values Comapared With Baseline |
236.821; 281.000; 310.375; 432.500; 271.000; 327.750 | — |
| PRIMARY Total Bilirubin (mg/dL) Laboratory Values |
0.497; 0.562; 0.553; 0.511; 0.559; 0.545 | — |
| PRIMARY ALP Laboratory Values |
98.980; 111.000; 102.341; 123.400; 97.357; 114.163 | — |
| PRIMARY ALT Laboratory Values |
23.336; 25.615; 29.615; 37.700; 27.071; 31.628 | — |
| PRIMARY AST Laboratory Values |
25.740; 32.769; 31.932; 50.700; 23.143; 36.116 | — |
| PRIMARY PR Interval Assessed by 12-Lead Electrocardiogram |
157.4; 159.1; 154.3; 159.2 | — |
| PRIMARY Diastolic Blood Pressure |
74.9; 74.1; 75.3; 74.9; 73.2 | — |
| PRIMARY Evaluation of Heart Rate (Beats Per Minute) |
794; 75.6; 78.7; 76.5; 84.0 | — |
| PRIMARY Evaluation of Respiration Rate |
16.8; 17.2; 16.9; 16.7; 17.1 | — |
| PRIMARY Evaluation of Temperature |
36.7; 36.7; 36.7; 36.7; 36.6 | — |
| PRIMARY QRS Interval Assessed by 12-Lead Electrocardiogram |
89.7; 90.4; 89.9; 90.5 | — |
| PRIMARY QT Interval Assessed by 12-Lead Electrocardiogram |
387.6; 394.0; 386.3; 398.3 | — |
| PRIMARY QTc Interval Assessed by 12-Lead Electrocardiogram |
428.8; 431.5; 430.3; 430.3 | — |
| SECONDARY Assessment of Baseline and On-treatment ⁸⁹Zr-Df-IAB22M2C Uptake and Distribution in Lymphoid Organs, and Measurement of Change Between the Paired Observations |
63.5; 58.7; 7.6; 7.4 | — |
| SECONDARY Measurement of Change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake in Biopsied Tumors as Determined by SUV-based Quantitative Analysis |
3.1; 5.1; 3.6; 4.0; 6.5; 4.6 | — |
| SECONDARY 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. |
34; 3; 6; 16; 2; 8 | — |
Eligibility Criteria
Inclusion Criteria
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.
- 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.
Exclusion Criteria
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
Data sourced from ClinicalTrials.gov (NCT03802123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.