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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

December 9, 2021

Primary Completion Date

July 31, 2025

Study Completion Date

July 31, 2025

Conditions
MelanomaMerkel Cell Carcinoma, UnspecifiedRenal Cell CarcinomaNon Small Cell Lung Cancer
Interventions
BIOLOGICAL

zirconium Zr 89 crefmirlimab berdoxam

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.

Trial Locations (16)

2109

Macquarie University Hospital, Macquarie Park

3084

Olivia Newton-John Cancer Research Insititute, Heidelberg

5000

Royal Adelaide Hospital, Adelaide

6525

Radboud University Medical Center, Nijmegen

10065

Memorial Sloan Kettering Cancer Center, New York

72205

CARTI Cancer Center, Little Rock

75390

UT Southwestern Medical Center, Dallas

90404

Providence Saint John's Cancer Institute, Santa Monica

91010

City of Hope, Duarte

98109

University of Washington, Seattle

Unknown

Princess Alexandra Hospital, Woolloongabba

Peter MacCallum Cancer Centre, Melbourne

University Hospitals Leuven, Leuven

Leiden University Medical Center, Leiden

Lausanne University Hospital, Lausanne

Northern Centre for Cancer Care and Newcastle University, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ImaginAb, Inc.

INDUSTRY