Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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:

For enrollment into Cohort A: Subjects with histologically confirmed advanced or metastatic non-uveal/non-mucosal melanoma or merkel cell carcinoma (MCPyV positive and negative) who are not amenable to surgical cure and are candidates to receive single- or combined IOT alone (not to include cytotoxic chemotherapy) as first or second line treatment.
For enrollment into Cohort B: Subjects with histologically confirmed advanced or metastatic clear cell Renal Cell Carcinoma or Renal Cell Carcinoma with sarcomatoid features (regardless of subtype) as defined on pathologic examination by a component of clear cell or sarcomatoid, who are not amenable to surgical cure and are candidates to receive single- or combined IOT alone or IOT in combination with VEGFR-directed or tyrosine kinase inhibitor (not to include cytotoxic chemotherapy) as first or second line treatment
For enrollment into Cohort C: Subjects with histologically confirmed advanced or metastatic non-small cell lung cancer without non-smoker/driver mutations who are not amenable to surgical cure, and are candidates to receive single- or combined IOT alone (not to include cytotoxic chemotherapy) as first or second line treatment as per the label/prescribing information at the physicians discretion.

i. Patients with driver mutations that are expected to show significant benefit from first line checkpoint inhibiter treatment (such as KRAS G12C mutations) are eligible if all other I/E criteria are met

Subjects must meet All of the criteria 2-9 below:

At least 1 RECIST 1.1-measurable. non-irradiated, non-osseous (unless there is an associated measurable soft-tissue component) lesion documented on intravenous (IV) contrast-enhanced CT or MRI (per RECIST criteria 1.1) prior to first zirconium Zr 89 crefmirlimab berdoxam administration.
Has an adequate amount of time between their prior treatment/procedure and the 1st administration of zirconium Zr 89 crefmirlimab berdoxam.
Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and anticipated survival of at least 6 months.
Meeting all clinical safety lab values per institution's SOC, or investigator's discretion, for subjects receiving cancer treatment.
Male or female age ≥18 years.
Ability to understand the purposes and risks of the trial and has signed an Institutional Review Board (IRB) approved informed consent form.
Willingness and ability to comply with all protocol required procedures.
For men and women of child-producing potential, use of effective double barrier contraceptive methods during the study, up to 30 days after the last administration of the investigational product.

Exclusion Criteria:

Subjects will NOT be eligible for enrollment in the study if they meet ANY of the following criteria:

Bone-only disease without a measurable soft tissue component on conventional imaging (MRI, PET, CT).
Subjects with skin-only (cutaneous) lesions will be excluded from the tumor biopsy assessment.
Serious nonmalignant disease, additional active malignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
Subjects with splenic dysfunction or who are status post splenectomy. Post-splenectomy subjects who develop an accessory spleen with clinical and radiographic evidence of splenic function will be allowed with prior approval from the Sponsor.
Corticosteroid therapy is prohibited if used for the treatment of inflammatory or autoimmune conditions. Patients with adrenal insufficiency from prior surgery or immunotherapy toxicity may be on standard chronic replacement doses of hydrocortisone that also require sporadic use of stress doses of steroid .
Pregnant women or nursing mothers.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT05013099

Recruitment Status:

Recruiting

Sponsor:

ImaginAb, Inc.

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There are 10 Locations for this study

See Locations Near You

CARTI Cancer Center
Little Rock Arkansas, 72205, United States More Info
Kelsey Williams
Contact
[email protected]
David Hays, MD
Principal Investigator
City of Hope
Duarte California, 91010, United States More Info
Jennifer Simpson
Contact
[email protected]
Jeffrey Wong, MD
Principal Investigator
Providence Saint John's Cancer Institute
Santa Monica California, 90404, United States More Info
Kelly Garver
Contact
[email protected]
Kim Margolin, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Sonya Brisbane
Contact
[email protected]
Neeta Pandit-Taskar, MD
Principal Investigator
UT Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Vida Rhodes
Contact
[email protected]
James Brugarolas, MD
Principal Investigator
University of Washington
Seattle Washington, 98109, United States More Info
Elsa Roberts, MD
Contact
[email protected]
Delphine Chen, MD
Principal Investigator
Macquarie University Hospital
Macquarie Park New South Wales, 2109, Australia More Info
Harrison O'Brien
Contact
[email protected]
Alison Zhang, MD
Principal Investigator
Princess Alexandra Hospital
Woolloongabba Queensland, , Australia More Info
Maria Vatca
Contact
[email protected]
Wen Xu, MD
Principal Investigator
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia More Info
Jesikah Logan
Contact
[email protected]
Michael Brown, MD
Principal Investigator
Olivia Newton-John Cancer Research Insititute
Heidelberg Victoria, 3084, Australia More Info
Tina Chen
Contact
[email protected]
Andrew Scott, MD
Principal Investigator
Peter MacCallum Cancer Centre
Melbourne Victoria, , Australia More Info
Leeanne Pasanen
Contact
[email protected]
Ramin Alipour
Principal Investigator
University Hospitals Leuven
Leuven , , Belgium More Info
Christophe Deroose, MD
Principal Investigator
Radboud University Medical Center
Nijmegen Gelderland, 6525, Netherlands More Info
Michel de Groot
Contact
[email protected]
Erik Aarntzen, MD
Principal Investigator
Leiden University Medical Center
Leiden , , Netherlands More Info
Ellen Kapiteijn, MD
Principal Investigator
Lausanne University Hospital
Lausanne , , Switzerland More Info
Niklaus Schaefer
Principal Investigator
Northern Centre for Cancer Care and Newcastle University
Newcastle Upon Tyne , , United Kingdom More Info
Rachel Pearson, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT05013099

Recruitment Status:

Recruiting

Sponsor:


ImaginAb, Inc.

How clear is this clinincal trial information?

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