Phase
Condition
Melanoma
Cancer/tumors
Kidney Cancer
Treatment
zirconium Zr 89 crefmirlimab berdoxam
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects will be eligible for enrollment in the study if they meet ONE criteria a, bor 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 confirmedadvanced or metastatic non-uveal/non-mucosal melanoma or merkel cellcarcinoma (MCPyV positive and negative) who are not amenable to surgicalcure and are candidates to receive single- or combined IOT alone (not toinclude cytotoxic chemotherapy) as first or second line treatment.
For enrollment into Cohort B: Subjects with histologically confirmedadvanced or metastatic clear cell Renal Cell Carcinoma or Renal CellCarcinoma with sarcomatoid features (regardless of subtype) as defined onpathologic examination by a component of clear cell or sarcomatoid, whoare not amenable to surgical cure and are candidates to receive single- orcombined IOT alone or IOT in combination with VEGFR-directed or tyrosinekinase inhibitor (not to include cytotoxic chemotherapy) as first orsecond line treatment
For enrollment into Cohort C: Subjects with histologically confirmedadvanced or metastatic non-small cell lung cancer withoutnon-smoker/driver mutations who are not amenable to surgical cure, and arecandidates to receive single- or combined IOT alone (not to includecytotoxic chemotherapy) as first or second line treatment as per thelabel/prescribing information at the physicians discretion. i. Patients with driver mutations that are expected to show significant benefitfrom 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 isan associated measurable soft-tissue component) lesion documented onintravenous (IV) contrast-enhanced CT or MRI (per RECIST criteria 1.1) prior tofirst 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 anticipatedsurvival of at least 6 months.
Meeting all clinical safety lab values per institution's SOC, or investigator'sdiscretion, for subjects receiving cancer treatment.
Male or female age ≥18 years.
Ability to understand the purposes and risks of the trial and has signed anInstitutional 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 barriercontraceptive methods during the study, up to 30 days after the lastadministration of the investigational product.
Exclusion
Exclusion Criteria:
- Subjects will NOT be eligible for enrollment in the study if they meet ANY of thefollowing criteria:
Bone-only disease without a measurable soft tissue component on conventionalimaging (MRI, PET, CT).
Subjects with skin-only (cutaneous) lesions will be excluded from the tumorbiopsy assessment.
Serious nonmalignant disease, additional active malignant disease or conditionsthat in the opinion of the investigator and/or ImaginAb could compromiseprotocol objectives.
Subjects with splenic dysfunction or who are status post splenectomy.Post-splenectomy subjects who develop an accessory spleen with clinical andradiographic evidence of splenic function will be allowed with prior approvalfrom the Sponsor.
Corticosteroid therapy is prohibited if used for the treatment of inflammatoryor autoimmune conditions. Patients with adrenal insufficiency from priorsurgery or immunotherapy toxicity may be on standard chronic replacement dosesof hydrocortisone that also require sporadic use of stress doses of steroid .
Pregnant women or nursing mothers.
Study Design
Connect with a study center
Macquarie University Hospital
Macquarie Park, New South Wales 2109
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, Queensland
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaSite Not Available
Olivia Newton-John Cancer Research Insititute
Heidelberg, Victoria 3084
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne, Victoria
AustraliaSite Not Available
University Hospitals Leuven
Leuven,
BelgiumSite Not Available
Radboud University Medical Center
Nijmegen, Gelderland 6525
NetherlandsSite Not Available
Leiden University Medical Center
Leiden,
NetherlandsSite Not Available
Lausanne University Hospital
Lausanne,
SwitzerlandSite Not Available
Northern Centre for Cancer Care and Newcastle University
Newcastle Upon Tyne,
United KingdomSite Not Available
CARTI Cancer Center
Little Rock, Arkansas 72205
United StatesSite Not Available
City of Hope
Duarte, California 91010
United StatesSite Not Available
HOAG Cancer Center
Irvine, California 92618
United StatesSite Not Available
Providence Saint John's Cancer Institute
Santa Monica, California 90404
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
UT Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
University of Washington
Seattle, Washington 98109
United StatesSite Not Available
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