Status:
COMPLETED
⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for PET/CT in Patients With Metastatic Solid Tumors
Lead Sponsor:
ImaginAb, Inc.
Conditions:
Positron-Emission Tomography
Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 immunohistochemi...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03802123
Start Date
December 18 2018
End Date
July 18 2022
Last Update
July 9 2024
Active Locations (15)
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1
University of Alabama-Birmingham Hospital
Birmingham, Alabama, United States, 35294
2
CARTI Cancer Center
Little Rock, Arkansas, United States, 72205
3
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States, 91010
4
Keck Hospital of USC
Los Angeles, California, United States, 90033