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

Last updated: July 19, 2024
Sponsor: ImaginAb, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Melanoma

Cancer/tumors

Kidney Cancer

Treatment

zirconium Zr 89 crefmirlimab berdoxam

Clinical Study ID

NCT05013099
IAB-CD8-203
  • Ages > 18
  • All Genders

Study 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.

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

  2. 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.

  3. 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

  4. 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:

  5. 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.

  6. Has an adequate amount of time between their prior treatment/procedure and the 1st administration of zirconium Zr 89 crefmirlimab berdoxam.

  7. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and anticipatedsurvival of at least 6 months.

  8. Meeting all clinical safety lab values per institution's SOC, or investigator'sdiscretion, for subjects receiving cancer treatment.

  9. Male or female age ≥18 years.

  10. Ability to understand the purposes and risks of the trial and has signed anInstitutional Review Board (IRB) approved informed consent form.

  11. Willingness and ability to comply with all protocol required procedures.

  12. 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:
  1. Bone-only disease without a measurable soft tissue component on conventionalimaging (MRI, PET, CT).

  2. Subjects with skin-only (cutaneous) lesions will be excluded from the tumorbiopsy assessment.

  3. Serious nonmalignant disease, additional active malignant disease or conditionsthat in the opinion of the investigator and/or ImaginAb could compromiseprotocol objectives.

  4. 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.

  5. 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 .

  6. Pregnant women or nursing mothers.

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: zirconium Zr 89 crefmirlimab berdoxam
Phase: 2
Study Start date:
December 09, 2021
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Macquarie University Hospital

    Macquarie Park, New South Wales 2109
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Olivia Newton-John Cancer Research Insititute

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria
    Australia

    Site Not Available

  • University Hospitals Leuven

    Leuven,
    Belgium

    Site Not Available

  • Radboud University Medical Center

    Nijmegen, Gelderland 6525
    Netherlands

    Site Not Available

  • Leiden University Medical Center

    Leiden,
    Netherlands

    Site Not Available

  • Lausanne University Hospital

    Lausanne,
    Switzerland

    Site Not Available

  • Northern Centre for Cancer Care and Newcastle University

    Newcastle Upon Tyne,
    United Kingdom

    Site Not Available

  • CARTI Cancer Center

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • HOAG Cancer Center

    Irvine, California 92618
    United States

    Site Not Available

  • Providence Saint John's Cancer Institute

    Santa Monica, California 90404
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98109
    United States

    Site Not Available

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