Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
zirconium Zr 89 crefmirlimab berdoxam · 1 trial · 4 indications
Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 from 3 (or up to 3) consecutive imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.
| Arm | Type | Description |
|---|---|---|
| Subjects with melanoma, Merkel cell, renal cell, or NSCLC | EXPERIMENTAL | Eligible subjects will receive 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 scan within 14 days prior to the onset of IOT, and a second scan 4 to 6 weeks after start of immunotherapy. The second zirconium Zr 89 crefmirlimab berdoxam administration and scan 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. |
| Name | Type | Description |
|---|---|---|
| zirconium Zr 89 crefmirlimab berdoxam | BIOLOGICAL | 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. |
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 ...
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Zirconium Zr 89 crefmirlimab berdoxam is an investigational monoclonal antibody being studied for use in melanoma and other advanced or metastatic malignancies. It is a diagnostic imaging agent designed for PET/CT scans to detect certain cancers. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Zirconium Zr 89 crefmirlimab berdoxam is a monoclonal antibody that binds to CD8, a protein found on the surface of cytotoxic T cells. By targeting CD8, it allows PET/CT imaging to visualize the presence and distribution of these immune cells within tumors, potentially helping to assess the immune response in cancer patients.
Zirconium Zr 89 crefmirlimab berdoxam is being developed by Telix Pharmaceuticals Limited, a biopharmaceutical company listed on the Australian Securities Exchange under the ticker TLX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational imaging agent in patients with advanced or metastatic cancers.
Zirconium Zr 89 crefmirlimab berdoxam is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 2 trial is active but not recruiting participants, and it is being studied in patients with melanoma and other advanced solid tumors.
Zirconium Zr 89 crefmirlimab berdoxam is being studied in a Phase 2 clinical trial registered as NCT05013099. This trial is titled 'Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies' and is enrolling approximately 70 participants with melanoma, Merkel cell carcinoma, renal cell carcinoma, or non-small cell lung cancer.
Zirconium Zr 89 crefmirlimab berdoxam is the radiolabeled form of crefmirlimab berdoxam, where the antibody is conjugated to the radioactive isotope zirconium-89 for PET imaging. The compound is often referred to by its full name to distinguish it from the unlabeled antibody, but they are related as the imaging agent and its precursor.