⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for PET/CT in Patients With Metastatic Solid Tumors

NCT03802123 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IAB-CD8-201
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Positron-Emission Tomography; Metastatic Solid Tumors

Keywords

PET/CT; ⁸⁹Zr-Df-IAB22M2C; CD8; Imaging

Outcome Measures

Primary Outcomes (29)

• 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.

  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

  Up to 12 weeks

• Participants With Signs and Symptoms of Infusion Reactions

  Number of participants with reported signs or symptoms of infusion reactions

  Up to 12 weeks

• Change in WBC Absolute Counts

  WBC absolute counts

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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)

  Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)

• Diastolic Blood Pressure

  Diastolic Blood Pressure

  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

  Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)

• Evaluation of Respiration Rate

  Changes/shifts in respiration rate

  Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)

• Evaluation of Temperature

  Changes/shifts in temperature

  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)

  Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)

• QT Interval Assessed by 12-Lead Electrocardiogram

  QT interval reported in milliseconds (msec)

  Baseline, Visit 2 (Day1), Visit 5 (Day 30-51)

• QTc Interval Assessed by 12-Lead Electrocardiogram

  QTc interval reported in milliseconds (msecs)

  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

  5 weeks

• Measurement of Change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake in Biopsied Tumors as Determined by SUV-based Quantitative Analysis

  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.

  7 weeks

Other Outcomes (4)

• Correlation of Visual and Quantitative ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake in Tumor Lesions With Change in CD8+ T Cells as Determined by IHC From Biopsy Samples Obtained Prior to and 4 to 7 Weeks After the Start of Immunotherapy.

  7 weeks

• Estimation of Positive Predictive Value, Negative Predictive Value, Sensitivity and Specificity of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) PET for Detecting CD8+ T Cells as Determined by IHC.

  7 weeks

• Assessment of Changes in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake and Distribution From Baseline to 5-7 Days Start of Immunotherapy if Available.

  7 weeks

Study Arms (1)

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.

Drug: ⁸⁹Zr-Df-IAB22M2C

Interventions

⁸⁹Zr-Df-IAB22M2C DRUG

⁸⁹Zr-Df-IAB22M2C CD8 T cell tracer for Positron Emission Tomography (PET)

⁸⁹Zr-Df-IAB22M2C Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be eligible for enrollment in the study only if they meet ALL of the following criteria:
• \. 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.

You may not qualify if:

• 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.
• \. Life expectancy \< 6 months

Sponsors & Collaborators

• ImaginAb, Inc.: lead

Study Sites (15)

University of Alabama-Birmingham Hospital

Birmingham, Alabama, 35294, United States

Location

CARTI Cancer Center

Little Rock, Arkansas, 72205, United States

Location

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, 91010, United States

Location

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

LAC + USC Medical Center

Los Angeles, California, 90033, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

John Wayne Cancer Institute at Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Dana-Farber Cancer Institute (DFCI)

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Pennsylvania, Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Seattle Cancer Care Alliance/ University of Washington

Seattle, Washington, 98109, United States

Location

Results Point of Contact

• Title: Director, Regulatory Affairs
• Organization: ImaginAb

ethomas@imaginab.com

: +1.310.730.5869

Study Officials

• Ron Korn, MD, PhD

  ImaginAb, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 14, 2019
• Study Start: December 18, 2018
• Primary Completion: October 19, 2021
• Study Completion: July 18, 2022
• Last Updated: July 9, 2024
• Results First Posted: July 9, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)