New Imaging Technique for Pancreatic Cancer

No longer recruiting at 9 trial locations

Overseen By Jason Lewis, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Cancer therapy, Investigational agents

Disqualifiers: Infections, Major surgery, HIV, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how well a new imaging agent, 89Zr-DFO-HuMab-5B1, adheres to pancreatic tumors and whether it produces clearer cancer images in PET/CT scans. The research targets individuals with confirmed or suspected pancreatic cancer. It suits those with pancreatic ductal adenocarcinoma, a common type of pancreatic cancer, who plan to undergo surgery or a biopsy as part of their regular care. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new imaging agent.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that ongoing cancer therapy or investigational agents are not allowed, except for MVT-5873.

What prior data suggests that this imaging technique is safe for pancreatic cancer patients?

Research has shown that the imaging agent 89Zr-DFO-HuMab-5B1, used in this trial, is safe for humans. In earlier studies, this agent was used in PET/CT scans and effectively identified certain types of cancer. Importantly, these studies found no major safety issues, and participants did not experience significant side effects, indicating that the treatment is safe for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this new imaging technique for pancreatic cancer because it uses a novel compound, 89Zr-DFO-HuMab-5B1, which is radiolabeled to help visualize tumors more effectively. Unlike traditional imaging methods, this technique targets a specific protein found on pancreatic cancer cells, potentially allowing for more precise detection and monitoring of the disease. By improving the accuracy of tumor imaging, this method could lead to better treatment planning and outcomes for patients, which is a significant advancement over current imaging options.

What evidence suggests that this imaging technique is effective for pancreatic cancer?

Research has shown that 89Zr-DFO-HuMab-5B1, the imaging agent under study in this trial, may aid in detecting pancreatic cancer. This agent binds to a cancer marker called CA19-9, commonly found in pancreatic tumors. Early results suggest that using this agent in PET/CT scans enhances tumor visibility. These scans have effectively identified cancers with the CA19-9 marker, potentially aiding in early pancreatic cancer detection. Early studies found this method safe, offering hope for improved cancer detection. ^{1 2 3 6 7}

Who Is on the Research Team?

Neeta Pandit-Taskar, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced pancreatic cancer or tumors that show a marker called CA19-9. They must be scheduled for surgery, have certain blood and organ function levels within set limits, and not be pregnant or breastfeeding. People with major recent surgeries, uncontrolled infections, HIV, or severe psychiatric issues cannot join.

Inclusion Criteria

Signed, informed consent

My CA19-9 levels are above normal, or my biopsy was CA19-9 positive.

I have a tumor that is at least 2 cm large, visible on CT or MRI.

Exclusion Criteria

You had a severe allergic reaction to a specific type of medication made from human or humanized antibodies.

Prior entry onto this protocol 3 or more times (e.g., subjects may enter this protocol and be imaged up to 3 times)

Pregnant or currently breast-feeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive a single, fixed, intravenous dose of MVT-2163 for imaging purposes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for treatment-related adverse events and biodistribution of MVT-2163

1 year

What Are the Treatments Tested in This Trial?

Interventions

• 89Zr-DFO-HuMab-5B1

Trial Overview The study tests an experimental imaging agent named 89Zr-DFO-HuMab-5B1 to see how well it attaches to pancreatic tumors during PET/CT scans. The goal is to improve the quality of tumor images in patients who are about to undergo surgery.

How Is the Trial Designed?

Group I: 89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging Experimental Treatment 2 Interventions

All subjects will receive a single, fixed, intravenous dose of MVT-2163, consisting of 3 mg (nominal mass - actual mass administered will likely vary between 2.0 and 2.5 mg) of MVT-2163 radiolabeled from 5 mCi to no less than 1.0 mCi (adjusted as of 16-Mar 2017) of 89Zr.Cohort 1 subjects will receive MVT-2163, with no MVT-5873 pre-dosing. Subjects in subsequent cohorts 2 and 3 will receive a dose of MVT-5873 15 minutes, \~ 2 hours, and \~4 hours prior to administration of MVT-2163. Future cohorts 4 and 5 may evaluate alternate time frames. Other cohorts may evaluate administration of MVT-5873 one week prior (D-7) to the day of MVT-2163 administration and a second administration of MVT-5873 the day of (D0) MVT-2163 administration. The re-entry (RE) and pre-surgery (PS) cohorts will administer MVT-2163 3 ± 1 hour after administration of MVT-5873.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

BioNTech SE

Industry Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02687230

Phase 1 Imaging Study of 89Zr-DFO-HuMab-5B1 With ... Open label, nonrandomized, dose-escalation trial of MVT-2163 and MVT-5873 used in performing PET scans. The study is designed to determine the best time and ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/58/supplement_1/385

First-in-Human Study of 89 Zr-DFO-HuMab-5B1 (MVT-2163 ... 89 Zr-DFO-HuMab-5B1 PET/CT imaging with HuMab-5B1 is safe and demonstrates promising results for the detection of CA 19-9 positive malignancies.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7052809/

Phase I Assessment of the High-Affinity CA19-9 Antibody ... We evaluated if immuno-PET with the radiolabeled high-affinity antibody HuMab-5B1 (MVT-2163), binding to the cancer antigen CA19-9, can identify the source of ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31540979/

Phase I Assessment of the High-Affinity CA19-9 Antibody ... Our study shows that the tumor antigen CA19-9 secreted to the circulation can be used for sensitive detection of primary tumors and ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/58/supplement_1/837

Biodistribution and radiation rose estimates for 89Zr-DFO ... First-in-Human Study of 89Zr-DFO-HuMab-5B1 (MVT-2163) PET/CT imaging with and without HuMab-5B1 (MVT-5873) in patients with pancreatic cancer ...

6. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT02687230/

Clinical Trial: NCT02687230 The ability of MVT-2163 to detect sites of disease (localized and metastatic) in pancreatic cancer and/or other CA19-9 positive malignancies.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04883775

Study of a New Technique for Imaging Pancreatic Cancer The purpose of this study is to see how well the experimental imaging agent 89Zr-DFO-HuMab-5B1 attaches to pancreatic tumors, and to find out whether PET/CT ...