Monoclonal Antibodies

zirconium Zr 89 crefmirlimab berdoxam for Melanoma

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

- i. Patients with driver mutations that are expected to show significant benefit from first line checkpoint inhibiter treatment (such as KRAS G12C mutations) are eligible if all other I/E criteria are met

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Study Summary

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

Eligible Conditions

Melanoma
Merkel Cell Carcinoma
Kidney Cancer
Non-Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

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

Select...

If you have certain gene mutations like KRAS G12C, which can be effectively treated with the study drug, you may be eligible to participate if you meet all other requirements.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

ImaginAb, Inc.Lead Sponsor

11 Previous Clinical Trials

200 Total Patients Enrolled

3 Trials studying Melanoma

32 Patients Enrolled for Melanoma

Kim Margolin, MDPrincipal Investigator

Providence 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.