Conditions

Melanoma Merkel Cell Carcinoma, Unspecified Renal Cell Carcinoma Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 tomography/computed tomography (PET/CT)
Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 from 3 (or up to 3) consecutive imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.
Baseline to at least 24 or 27 weeks after the start of IOT, depending on treatment schedule.

Secondary Outcomes (24)

Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI)
Baseline to at least 24 or 27 weeks after the start IOT, depending on treatment schedule.
Incidence and severity of AEs
Up to 48 weeks or end of treatment.
Incidence and severity of infusion or injection reactions
33 days post infusion
Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs
Up to 48 weeks or end of treatment
12-lead ECG ventricular rate (bpm)
baseline to 48 weeks or end of study
+19 more secondary outcomes

Other Outcomes (6)

Evaluate zirconium Zr 89 crefmirlimab berdoxam PET/CT as a discriminator of pseudo-progression.
Up to 48 weeks or end of treatment.
Evaluate zirconium Zr 89 crefmirlimab berdoxam PET/CT in subjects who develop clinical and/or radiographic progression to explore mechanisms for treatment resistance.
Up to 48 weeks or end of treatment.
Evaluate zirconium Zr 89 crefmirlimab berdoxam PET/CT as a predictor or surrogate for IOT immune related adverse events (irAEs).
Up to 48 weeks or end of treatment.
+3 more other outcomes

Study Arms (1)

Subjects with melanoma, Merkel cell, renal cell, or NSCLC

EXPERIMENTAL

Eligible subjects will receive up to three zirconium Zr 89 crefmirlimab berdoxam PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion or slow bolus injection as follows: First scan within 14 days prior to the onset of IOT, and a second scan 4 to 6 weeks after start of immunotherapy. The second zirconium Zr 89 crefmirlimab berdoxam administration and scan should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third zirconium Zr 89 crefmirlimab berdoxam PET scan at the principal investigator's (PI's) discretion.

Biological: zirconium Zr 89 crefmirlimab berdoxam

Interventions

zirconium Zr 89 crefmirlimab berdoxamBiological

Up to three zirconium Zr 89 crefmirlimab berdoxam PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion or slow bolus injection as follows: First (PETbaseline) within 14 days prior to the onset of IOT, and a second (PETEOC1) 4 to 6 weeks after start of immunotherapy. The second zirconium Zr 89 crefmirlimab berdoxam administration and scan (PETEOC1) should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third zirconium Zr 89 crefmirlimab berdoxam PET scan at the principal investigator's (PI's) discretion.

Also known as: 89Zr-Df-crefmirlimab, 89Zr-Df-IAB22M2C

Subjects with melanoma, Merkel cell, renal cell, or NSCLC

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects will be eligible for enrollment in the study if they meet ONE criteria a, b or c in point 1 and ALL the criteria in points 2-9.
Subjects must meet ONE of the criteria a, b or c below:

Sponsors & Collaborators

ImaginAb, Inc.
Industrylead

Study Sites (16)

CARTI Cancer Center

Little Rock, Arkansas, 72205, United States

City of Hope

Duarte, California, 91010, United States

Providence Saint John's Cancer Institute

Santa Monica, California, 90404, United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

University of Washington

Seattle, Washington, 98109, United States

Macquarie University Hospital

Macquarie Park, New South Wales, 2109, Australia

MeSH Terms

Conditions

MelanomaCarcinoma, Merkel CellCarcinoma, Renal CellCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Kim Margolin, MD
Providence Saint John's Cancer Institute
PRINCIPAL INVESTIGATOR

Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (24)

Other Outcomes (6)

Study Arms (1)

Subjects with melanoma, Merkel cell, renal cell, or NSCLC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (16)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (24)

Other Outcomes (6)

Study Arms (1)

Subjects with melanoma, Merkel cell, renal cell, or NSCLC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (16)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations