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Monoclonal Antibodies

Imaging with Zirconium Zr 89 Crefmirlimab Berdoxam for Cancer (iPREDICT Trial)

Phase 2

Recruiting

Led By Kim Margolin, MD

Research Sponsored by ImaginAb, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and anticipated survival of at least 6 months

Subjects with histologically confirmed advanced or metastatic non-uveal/non-mucosal melanoma or merkel cell carcinoma (MCPyV positive and negative) who are not amenable to surgical cure and are candidates to receive single- or combined IOT alone (not to include cytotoxic chemotherapy) as first or second line treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to at least 24 or 27 weeks after the start iot, depending on treatment schedule.

Awards & highlights

iPREDICT Trial Summary

This trial will test whether a new imaging tool can predict which cancer patients are likely to respond to immunotherapy.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects aren't specified here but generally include reactions related to the injection site such as pain or swelling, allergic reactions to the tracer substance used in imaging scans, and any risks associated with additional exposure to radiation from the PET/CT scan.

iPREDICT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself and doctors expect me to live at least 6 more months.

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I have advanced melanoma or Merkel cell carcinoma and can't be treated with surgery.

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I have a measurable cancer lesion that has not been treated with radiation.

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My cancer has a mutation like KRAS G12C that responds well to specific immune treatments.

Select...

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

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I am 18 years old or older.

iPREDICT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to at least 24 or 27 weeks after the start of iot, depending on treatment schedule.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to at least 24 or 27 weeks after the start of iot, depending on treatment schedule.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to at least 24 or 27 weeks after the start of iot, depending on treatment schedule. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 tomography/computed tomography (PET/CT)

Secondary outcome measures

12-lead ECG Overall Result

12-lead ECG PR interval (msec)

12-lead ECG QRS interval (msec)

+21 more

Other outcome measures

Positron-Emission Tomography

Zirconium

Evaluate zirconium Zr 89 crefmirlimab berdoxam PET/CT as a predictor of duration of response (DoR).

+3 more

iPREDICT Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects with melanoma, Merkel cell, renal cell, or NSCLCExperimental Treatment1 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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

ImaginAb, Inc.Lead Sponsor

12 Previous Clinical Trials

220 Total Patients Enrolled

3 Trials studying Melanoma

32 Patients Enrolled for Melanoma

Kim Margolin, MDPrincipal InvestigatorProvidence Saint John's Cancer Institute

1 Previous Clinical Trials

123 Total Patients Enrolled

Media Library

Crefmirlimab Berdoxam (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05013099 — Phase 2

Melanoma Research Study Groups: Subjects with melanoma, Merkel cell, renal cell, or NSCLC

Melanoma Clinical Trial 2023: Crefmirlimab Berdoxam Highlights & Side Effects. Trial Name: NCT05013099 — Phase 2

Crefmirlimab Berdoxam (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05013099 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are signing up to be a part of this clinical trial?

"The sponsor, ImaginAb, Inc., needs to recruit 80 eligible individuals from City of Hope (City of Hope National Medical Center and City of Hope Medical Center) in Duarte, Arkansas and CARTI Cancer Center in Little Rock, Washington."

Answered by AI

Is zirconium Zr 89 crefmirlimab berdoxam a drug that has been cleared for use by the FDA?

"Zirconium Zr 89 crefmirlimab berdoxam is a medication that is currently being trialled in Phase 2 clinical trials. This means that while there is some data supporting its safety, there is none yet affirming its efficacy."

Answered by AI

Are we still enrolling participants for this research?

"Yes, as reflected on clinicaltrials.gov, this study is still open to patient recruitment. The trial was initially posted on December 9th 2021 and edited for the 8th time on August 23rd, 2022."

Answered by AI

What is the proposed outcome of this experiment?

"According to the trial sponsor, ImaginAb, Inc., the primary objective of this study is to measure Best overall response (BOR) using conventional imaging CT and/or MRI over a period of 24-27 weeks. Secondary objectives include Change in blood ALT levels (U/L), incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs, and Change in blood BUN levels (mg/dL)."

Answered by AI

How many research centers are conducting this clinical trial?

"At the moment, there are 5 sites where this trial is taking place. They are situated in Duarte, Little Rock and Irvine as well as a couple other places. It would be practical to choose the centre that is closest to you when enrolling to reduce travel time commitments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05013099.

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