New Imaging Technique for Pancreatic Cancer

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

4 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new imaging substance called 89Zr-DFO-HuMab-5B1. It aims to help doctors see pancreatic tumors more clearly during scans. The study focuses on people with pancreatic cancer to improve how well these tumors can be seen.

Research Team

Neeta Pandit-Taskar, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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