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

Completed · Phase 2

Conditions studied: Positron-Emission Tomography, Metastatic Solid Tumors

In brief

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.

Key facts

Study ID

NCT03802123

Run by

ImaginAb, Inc.

People needed

52

Starts

2018-12-18

Expected to finish

2022-07-18

Last updated by the study team

2024-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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.
• 5. Life expectancy < 6 months

Where it is running

• University of Alabama-Birmingham Hospital — Birmingham, Alabama, United States
• CARTI Cancer Center — Little Rock, Arkansas, United States
• City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California, United States
• Keck Hospital of USC — Los Angeles, California, United States
• LAC + USC Medical Center — Los Angeles, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• John Wayne Cancer Institute at Providence Saint John's Health Center — Santa Monica, California, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Dana-Farber Cancer Institute (DFCI) — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Pennsylvania, Perelman School of Medicine — Philadelphia, Pennsylvania, United States
• Seattle Cancer Care Alliance/ University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.