Status:
COMPLETED
Zr89 + PET Companion Trial
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
ImaginAb, Inc.
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Study of Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT as an imaging biomarker for assessing an early response to therapy in patients with advanced melanoma on immunotherapy and hydroxychloroquine. This...
Detailed Description
This is a single institution, prospective cohort study of Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT as an early measure of response in patients with melanoma. This study is a companion imaging study...
Eligibility Criteria
Inclusion
- Adult patients, at least 18 years of age
- History of histologically confirmed melanoma as assessed per medical record review.
- At least one site of measurable disease (per RECIST 1.1) that is seen on CT, MRI, or FDG PET/CT.
- Potentially eligible to participate in the LIMIT Melanoma Trial.
- Patients must have adequate baseline organ function as determined per LIMIT Melanoma Trial (IRB 835033) (these tests will be completed as part of LIMIT trial screening and will not be repeated for the imaging companion study)
- Adequate organ function: per LIMIT Melanoma Trial (IRB 35033)
- System Laboratory Values Hematologic Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L Hemoglobin ≥ 9 g/dL Platelet Count ≥ 100 x 109/L PT/INRa and PTT ≤ 1.3 x ULN Hepatic Total Bilirubinb ≤ 1.5 x ULN AST and ALT ≤ 2.5 x ULN Renal Serum Creatinine ≤ 1.5 mg/dL Abbreviations: ALT = alanine transaminase; ANC = absolute neutrophil count; AST = aspartate aminotransferase; INR = international normalized ratio; LLN = lower limit of normal; PT = prothrombin time; PTT = partial thromboplastin time; ULN = upper limit of normal.
- a Subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to enrollment.
- b Subjects with known Gilbert's syndrome must have a total bilirubin \< 3.0 x ULN).
- c If serum creatinine is \> 1.5 mg/dL, calculate creatinine clearance using standard Cockcroft-Gault formula. Creatinine clearance must be ≥ 50 mL/min to be eligible.
- Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
Exclusion
- Females who report they are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine pregnancy test prior to infusion of the study radiotracer to confirm they are not pregnant.
- Patients who have any splenic disorders, or had splenectomy, that in the opinion of an investigator could compromise protocol objectives.
- Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
- Ineligible for the LIMIT Melanoma Trial.
Key Trial Info
Start Date :
March 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2025
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05279027
Start Date
March 8 2022
End Date
May 6 2025
Last Update
September 19 2025
Active Locations (1)
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1
Perleman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104