Imaging with Zirconium Zr 89 Crefmirlimab Berdoxam for Cancer

(iPREDICT Trial)

Recruiting at 18 trial locations

Overseen by Kim Margolin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: ImaginAb, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a special imaging test to see if it can predict how well treatments are working for patients with serious types of cancer.

Research Team

Kim Margolin, MD

Principal Investigator

Providence Saint John's Cancer Institute

Eligibility Criteria

Adults with advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma, or non-small cell lung cancer who can't be cured by surgery. They should have a life expectancy of at least 6 months, meet safety lab values for treatment, and not be pregnant or breastfeeding. Participants must agree to use effective contraception and have measurable tumors that haven't been treated with radiation.

Inclusion Criteria

I have advanced kidney cancer that can't be removed by surgery and am eligible for certain drug treatments.

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

I have waited long enough since my last treatment to start zirconium Zr 89 crefmirlimab berdoxam.

Exclusion Criteria

I am not on corticosteroids for inflammation or autoimmune issues, but may use them for adrenal insufficiency.

I have had my spleen removed or it doesn't work properly, but I might have a functioning accessory spleen.

My cancer is only in the bones and doesn't show up in soft tissues on scans.

Treatment Details

Interventions

• Crefmirlimab Berdoxam (Monoclonal Antibodies)

Trial Overview The trial is testing if a PET/CT scan using zirconium Zr 89 crefmirlimab berdoxam can predict how well these cancers will respond to immunotherapy treatments. It's for patients who are receiving immunotherapy as their first or second line of treatment.

Participant Groups

Group I: Subjects with melanoma, Merkel cell, renal cell, or NSCLC Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

ImaginAb, Inc.

Lead Sponsor

Trials

13

Recruited

280+