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

Overview

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.

Eligibility

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.
  1. Subjects must meet ONE of the criteria a, b or c below:
     1. 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.
     2. 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
     3. 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.
     4. 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:

               2. 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.
               3. Has an adequate amount of time between their prior treatment/procedure and the
                  1st administration of zirconium Zr 89 crefmirlimab berdoxam.
               4. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and anticipated
                  survival of at least 6 months.
               5. Meeting all clinical safety lab values per institution's SOC, or investigator's
                  discretion, for subjects receiving cancer treatment.
               6. Male or female age ≥18 years.
               7. Ability to understand the purposes and risks of the trial and has signed an
                  Institutional Review Board (IRB) approved informed consent form.
               8. Willingness and ability to comply with all protocol required procedures.
               9. 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:
               1. Bone-only disease without a measurable soft tissue component on conventional
                  imaging (MRI, PET, CT).
               2. Subjects with skin-only (cutaneous) lesions will be excluded from the tumor
                  biopsy assessment.
               3. Serious nonmalignant disease, additional active malignant disease or conditions
                  that in the opinion of the investigator and/or ImaginAb could compromise protocol
                  objectives.
               4. 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.
               5. 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 .
               6. Pregnant women or nursing mothers.