Imaging with Zirconium Zr 89 Crefmirlimab Berdoxam for Cancer

(iPREDICT Trial)

Recruiting at 18 trial locations

Overseen By Kristin Schmiedehausen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ImaginAb, Inc.

Must be taking: Immuno-oncology therapy

Must not be taking: Corticosteroids

Disqualifiers: Bone-only disease, Skin-only lesions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

70 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Kim Margolin, MD

Principal Investigator

Providence Saint John's Cancer Institute

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Treatment Initiation

Participants receive the first zirconium Zr 89 crefmirlimab berdoxam PET scan within 14 days prior to the onset of immunotherapy, followed by a second scan 4 to 6 weeks after the start of immunotherapy.

6-8 weeks

2 visits (in-person)

Ongoing Treatment and Monitoring

Participants continue immunotherapy with optional third PET scan if progression is determined. Monitoring includes blood tests and imaging assessments.

Up to 48 weeks

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Crefmirlimab Berdoxam

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.

How Is the Trial Designed?

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+