Zr89 Imaging for Melanoma

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Must be taking: Immunotherapy, Hydroxychloroquine

Disqualifiers: Pregnancy, Splenic disorders, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assess treatment effectiveness for advanced melanoma, a type of skin cancer. It employs a special imaging technique using Zirconium Zr 89 Crefmirlimab Berdoxa to evaluate early responses to treatments like immunotherapy and hydroxychloroquine. This approach could help doctors understand the disease's response to treatment sooner. Individuals with melanoma who may qualify for the LIMIT Melanoma Trial and have visible signs of the disease could be suitable candidates for this study. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to benefit from this innovative approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since the study involves patients already on immunotherapy and hydroxychloroquine, it seems likely you can continue these treatments.

What prior data suggests that this imaging technique is safe for assessing melanoma?

Research has shown that Zirconium Zr 89 Crefmirlimab Berdoxa has been used in studies with cancer patients who met specific safety criteria, indicating the treatment was considered safe for them. In other studies, participants needed to perform daily activities and have an expected survival time of at least six months, suggesting the treatment is generally well-tolerated. However, as this is an early-stage trial, safety continues to be closely monitored. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Crefmirlimab Berdoxa for melanoma because it offers a unique approach to monitoring treatment response. Unlike conventional treatments like immune checkpoint inhibitors and targeted therapies, this method uses a novel imaging technique called 89Zr-Df-IAB22M2C PET/CT. This technique allows doctors to visualize how well the treatment is working much earlier than traditional methods, potentially leading to faster and more personalized adjustments in patient care. By providing early feedback, it could revolutionize how treatment progress is assessed in melanoma patients.

What evidence suggests that Zirconium Zr 89 Crefmirlimab Berdoxa is effective for imaging in melanoma?

Research has shown that Zirconium Zr 89 Crefmirlimab Berdoxa, administered to participants in this trial for PET/CT scans, helps doctors assess treatment effectiveness in advanced melanoma. Related studies have used this imaging method to detect early tumor changes after treatment begins. This capability is crucial for adjusting therapies to improve patient outcomes. While primarily focused on detecting therapy responses, it may also identify side effects early. This imaging agent aids in tracking tumor progress, potentially leading to better treatment decisions. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Adults with advanced melanoma who are eligible for the LIMIT Melanoma Trial, have at least one measurable disease site, and proper organ function. Pregnant or breastfeeding women, those unable to tolerate imaging procedures, with serious medical conditions, ineligible for the LIMIT trial or with splenic disorders are excluded.

Inclusion Criteria

My organs are functioning well enough for the LIMIT Melanoma Trial.

I have at least one tumor that can be measured on scans.

My melanoma diagnosis has been confirmed by a tissue examination.

Exclusion Criteria

Ineligible for the LIMIT Melanoma Trial

I have a spleen condition or had my spleen removed that may affect the study.

Inability to tolerate imaging procedures in the opinion of the investigator or treating physician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Imaging

Participants undergo a Baseline Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT scan prior to starting therapy

1 week

1 visit (in-person)

Treatment Imaging

Participants undergo a Post-Treatment Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT scan at day 14 post therapy

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Crefmirlimab Berdoxa
• Zirconium Zr 89 Crefmirlimab Berdoxa

Trial Overview The study tests Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT as a marker for early response in melanoma patients receiving immunotherapy and hydroxychloroquine. It aims to correlate imaging results with progression-free survival (PFS) and overall survival (OS).

How Is the Trial Designed?

Group I: PET imaging Experimental Treatment 1 Intervention

This is a single institution, prospective cohort study of 89Zr-Df-IAB22M2C PET/CT as an early measure of response in patients with melanoma.

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

ImaginAb, Inc.

Industry Sponsor

Trials

13

Recruited

280+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05279027

Study Details | Zr89 + PET Companion Trial This is a single institution, prospective cohort study of Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT as an early measure of response in patients with melanoma.

2. 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 ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-early-detection-of-side-effects-in-metastatic-melanoma-patients-using-zirconium-89zr-crefmirlimab-berdoxam-imaging/

Study on Early Detection of Side Effects in Metastatic ... Study on Early Detection of Side Effects in Metastatic Melanoma Patients Using Zirconium (89Zr) Crefmirlimab Berdoxam Imaging.

4. withpower.com withpower.com/trial/early-phase-1-melanoma-2-2022-e93b0

Zr89 Imaging for Melanoma · Info for Participants Study of Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT as an imaging biomarker for assessing an early response to therapy in patients with advanced melanoma ...

5. bepartofresearch.nihr.ac.uk bepartofresearch.nihr.ac.uk/trial-details/trial-detail?trialId=42742&location=&distance=

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

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

NCT05013099 | Study of Zirconium Zr 89 Crefmirlimab ... Meeting all clinical safety lab values per institution's SOC, or investigator's discretion, for subjects receiving cancer treatment. Male or female age ≥18 ...

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

Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/​CT ... Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and anticipated survival of at least 6 months. Meeting all clinical safety lab values per ...

8. trials.braintumor.org trials.braintumor.org/trials/NCT05279027

Zr89 + PET Companion Trial - National Brain Tumor Society This is a single institution, prospective cohort study of Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT as an early measure of response in patients with melanoma.

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

Zirconium (89Zr) Crefmirlimab Berdoxam This clinical trial focuses on patients with metastatic melanoma, a type of skin cancer that has spread to other parts of the body. The study is investigating a ...

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 ...