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ACTIVE NOT RECRUITING
NCT05013099
PHASE2

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

Sponsor: ImaginAb, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate whether zirconium Zr 89 crefmirlimab berdoxam (other names 89Zr-crefmirlimab berdoxam, 89Zr-Df-crefmirlimab, 89Zr-Df-IAB22M2C) PET/CT can predict the response of advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma, or non-small cell lung cancer tumors to immuno-oncology therapy.

Official title: A Phase IIB, Open Label, Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies, Scheduled to Receive Immunotherapy (IOT) as a Single Agent or Combination, to Predict Response to Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2021-12-09

Completion Date

2025-07

Last Updated

2024-07-22

Healthy Volunteers

No

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.

Locations (16)

CARTI Cancer Center

Little Rock, Arkansas, United States

City of Hope

Duarte, California, United States

Providence Saint John's Cancer Institute

Santa Monica, California, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

UT Southwestern Medical Center

Dallas, Texas, United States

University of Washington

Seattle, Washington, United States

Macquarie University Hospital

Macquarie Park, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Olivia Newton-John Cancer Research Insititute

Heidelberg, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

University Hospitals Leuven

Leuven, Belgium

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Leiden University Medical Center

Leiden, Netherlands

Lausanne University Hospital

Lausanne, Switzerland

Northern Centre for Cancer Care and Newcastle University

Newcastle upon Tyne, United Kingdom