Imaging with Zirconium Zr 89 Crefmirlimab Berdoxam for Cancer

(iPREDICT Trial)

Not currently recruiting at 19 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special imaging technique using zirconium Zr 89 crefmirlimab berdoxam (an experimental imaging agent) can predict the response of certain cancers to new immune-based treatments. The focus is on advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma, and non-small cell lung cancer. Participants will undergo up to three PET scans to monitor treatment progress. This trial may suit individuals with these specific cancers who are not candidates for surgery but are eligible for immune therapy. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but corticosteroid therapy for inflammatory or autoimmune conditions is not allowed. If you are on such medications, you may need to stop them to participate.

What prior data suggests that zirconium Zr 89 crefmirlimab berdoxam is safe for imaging in cancer patients?

Research has shown that zirconium Zr 89 crefmirlimab berdoxam is generally well-tolerated in human studies. This treatment serves as a special imaging agent in PET scans, enhancing the visibility of immune cells in the body.

In earlier studies, patients who received this imaging treatment did not report major safety issues. The amount of radioactive zirconium used remains low enough to be safe for imaging. The zirconium Zr 89 component emits a small amount of radiation, which is typical for PET scans and aligns with medical safety guidelines.

As the treatment undergoes further testing in clinical trials, its safety continues to be evaluated. However, earlier studies have shown promising results, warranting continued research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about zirconium Zr 89 crefmirlimab berdoxam because it offers a novel way to visualize cancer activity in real-time. Unlike standard treatments for cancers like melanoma, Merkel cell carcinoma, renal cell carcinoma, or non-small cell lung cancer (NSCLC) that focus on directly attacking the cancer cells, this approach uses a PET scan with a radioactive tracer to provide detailed images of how cancer responds to immunotherapy. This imaging technique allows for better monitoring of the treatment's effectiveness, potentially leading to more personalized and timely adjustments in therapy. By visualizing the cancer's response early in the treatment process, doctors can make more informed decisions and adjust therapies to improve patient outcomes.

What evidence suggests that zirconium Zr 89 crefmirlimab berdoxam PET/CT is effective for predicting the response of cancer tumors to immuno-oncology therapy?

Research is exploring whether zirconium Zr 89 crefmirlimab berdoxam can predict how well certain cancers respond to immunotherapy, a treatment that uses the body's defense system to fight cancer. In studies with renal cell carcinoma, a type of kidney cancer, this imaging technique has shown promise in identifying immune cells that might indicate a patient's response to cancer treatment. In this trial, participants with melanoma, Merkel cell carcinoma, renal cell carcinoma, and non-small cell lung cancer will undergo up to three zirconium Zr 89 crefmirlimab berdoxam PET scans to assess this potential. The goal is to better understand which patients might benefit most from their treatment. Early findings suggest that this imaging method could guide treatment decisions for these cancers. ^{6 7 8 9 10}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05013099

NCT05013099 | Study of Zirconium Zr 89 Crefmirlimab ... The purpose of this study is to evaluate whether zirconium Zr 89 crefmirlimab berdoxam (other names 89Zr-crefmirlimab berdoxam, 89Zr-Df-crefmirlimab, ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/study/NCT05013099

Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/​CT ... The purpose of this study is to evaluate whether zirconium Zr 89 crefmirlimab berdoxam (other names 89Zr-crefmirlimab berdoxam, 89Zr-Df-crefmirlimab, ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.4551

CD8 cell PET imaging with 89-Zr-crefmirlimab berdoxam ... This is the first series in RCC to demonstrate that functional imaging of immune cells (here, CD8s) may segregate response to CPIs.

4. aacrjournals.org aacrjournals.org/cancerres/article/82/12_Supplement/CT132/703178/Abstract-CT132-iPREDICT-trial-A-phase-IIb-open

Abstract CT132: iPREDICT trial: A phase IIb, open label study ... iPREDICT trial: A phase IIb, open label study of 89Zr-Crefmirlimab Berdoxam PET/CT in subjects with selected advanced malignancies (melanoma, ...

5. trialx.com trialx.com/clinical-trials/listings/227180/study-of-zirconium-zr-89-crefmirlimab-berdoxam-petct-in-subjects-with-advanced-or-metastatic-malignancies/

Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in ... Overview. The purpose of this study is to evaluate whether zirconium Zr 89 crefmirlimab berdoxam (other names 89Zr-crefmirlimab berdoxam, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05013099

NCT05013099 | Study of Zirconium Zr 89 Crefmirlimab ... 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 ...

7. uclahealth.org uclahealth.org/clinical-trials/zr-89-crefmirlimab-berdoxam-and-immuno-positron-emission

Zr-89 Crefmirlimab Berdoxam and Immuno-Positron ... This phase I trial studies how well zirconium (Zr)-89 crefmirlimab berdoxam and immuno-positron emission tomography (PET) identifies areas of immune cell ...

8. jnm.snmjournals.org jnm.snmjournals.org/content/65/supplement_2/241595

The Scientific and Clinical Potentials of Imaging Cytotoxic ... Zr-89 crefmirlimab berdoxam provides an imaging technology with sufficient sensitivity and whole-body coverage to evaluate CD8 cell (re-)distribution and ...

9. clinicaltrials.eu clinicaltrials.eu/inn/zirconium-89zr-crefmirlimab-berdoxam/

Zirconium (89Zr) Crefmirlimab Berdoxam The zirconium-89 component of the compound emits a small amount of radiation that can be detected by a PET scanner, allowing doctors to see where these ...

10. cancer.gov cancer.gov/publications/dictionaries/cancer-drug/def/zirconium-zr-89-crefmirlimab-berdoxam

Definition of zirconium Zr 89 crefmirlimab berdoxam Upon administration, zirconium Zr 89 crefmirlimab berdoxam specifically targets and binds to the CD8 antigen expressed on T cells. This enables PET detection of ...