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Zr89 + PET Companion Trial

Primary Purpose

Melanoma (Skin)

Status

Enrolling by invitation

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Zirconium Zr 89 Crefmirlimab Berdoxa

About this trial

This is an interventional diagnostic trial for Melanoma (Skin) focused on measuring Positron Emission Tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Perleman Center for Advanced Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET imaging

Arm Description

This is a single institution, prospective cohort study of 89Zr-Df-IAB22M2C PET/CT as an early measure of response in patients with melanoma.

Outcomes

Primary Outcome Measures

Zirconium Zr 89 Crefmirlimab Berdoxa uptake

Zirconium Zr 89 Crefmirlimab Berdoxa measured uptake *(by standard uptake value) on Baseline and post-Treatment PET/CT scans in tumor lesions and lymphoid organs.

Change in uptake post therapy

Measurement of change in Zirconium Zr 89 Crefmirlimab Berdoxa uptake between Baseline and post-Treatment PET/CT scans in tumor lesions and lymphoid organs.

Secondary Outcome Measures

Post therapy outcomes

Association between change in tumor Zirconium Zr 89 Crefmirlimab Berdoxa uptake and objective response, progression free survival, and overall survival.

CD8+ TIL density in tumor

Association between tumor Zirconium Zr 89 Crefmirlimab Berdoxa uptake and CD8+ TIL density in biopsied tumors.

Full Information

NCT ID

NCT05279027

First Posted

March 8, 2022

Last Updated

August 14, 2023

Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

ImaginAb, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05279027

Brief Title

Zr89 + PET Companion Trial

Official Title

Zirconium Zr 89 Crefmirlimab Berdoxam (Anti-CD8 Minibody) PET/CT Imaging as a Measure of Response in Patients With Advanced Melanoma on Immunotherapy Plus Hydroxychloroquine.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

March 8, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

ImaginAb, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 study is a companion study to the "LIMIT Melanoma Trial." Patients with melanoma who are potentially eligible for the LIMIT Melanoma Trial and have at least one site of measurable disease based on RECIST 1.1 are potentially eligible. Associations with progression-free survival (PFS) and overall survival (OS) will be tested.

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 to the "LIMIT Melanoma Trial". Patients with melanoma who are candidates for the LIMIT Melanoma treatment trial and are at least 18 years of age may be eligible. All participants will be receiving care at the clinical practices of the University of Pennsylvania. Patients will be approached about study participation regardless of race or ethnic background. We anticipate enrolling up to 20 evaluable participants with melanoma who meet eligibility requirements for this study. An evaluable patient has completed Baseline and at the post-Treatment Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT scans. Accrual is estimated to occur over approximately 3 years. After undergoing screening assessments and verifying eligibility for study participation subjects will be scheduled to undergo a BaselineZirconium Zr 89 Crefmirlimab Berdoxa PET/CT scan prior to starting immunotherapy + HCQ therapy. For the Baseline study, subjects will be injected with Zirconium Zr 89 Crefmirlimab Berdoxa up to 8 days prior to starting therapy (Day -8 to 0), and will undergo PET/CT imaging 24 ± 4 hours post injection, and prior to therapy administration. Subjects will then undergo a Post-Treatment Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT scan at day 14 (± 4 days) post therapy, which will require administration of Zirconium Zr 89 Crefmirlimab Berdoxa on the day prior to the scan. Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT scans will be acquired with an interval of ≥ 10 days between scans, to ensure that the signal from the previous injection of Zirconium Zr 89 Crefmirlimab Berdoxa has decayed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma (Skin)

Keywords

Positron Emission Tomography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PET imaging

Arm Type

Experimental

Arm Description

This is a single institution, prospective cohort study of 89Zr-Df-IAB22M2C PET/CT as an early measure of response in patients with melanoma.

Intervention Type

Drug

Intervention Name(s)

Zirconium Zr 89 Crefmirlimab Berdoxa

Intervention Description

Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT scans pre and post therapy initiation

Primary Outcome Measure Information:

Title

Zirconium Zr 89 Crefmirlimab Berdoxa uptake

Description

Zirconium Zr 89 Crefmirlimab Berdoxa measured uptake *(by standard uptake value) on Baseline and post-Treatment PET/CT scans in tumor lesions and lymphoid organs.

Time Frame

21 days

Title

Change in uptake post therapy

Description

Measurement of change in Zirconium Zr 89 Crefmirlimab Berdoxa uptake between Baseline and post-Treatment PET/CT scans in tumor lesions and lymphoid organs.

Time Frame

21 days

Secondary Outcome Measure Information:

Title

Post therapy outcomes

Description

Association between change in tumor Zirconium Zr 89 Crefmirlimab Berdoxa uptake and objective response, progression free survival, and overall survival.

Time Frame

until the end of the study, usually about 3 years

Title

CD8+ TIL density in tumor

Description

Association between tumor Zirconium Zr 89 Crefmirlimab Berdoxa uptake and CD8+ TIL density in biopsied tumors.

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Facility Information:

Facility Name

Perleman Center for Advanced Medicine

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

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Zr89 + PET Companion Trial

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