PET Imaging Using 64Cu-Tz-SarAr and hu5B1-TCO in People With Pancreatic, Colorectal, Bladder Cancer or Cancers With Elevated CA19.9

Overseen By Neeta Pandit-Taskar, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: 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: Unknown

Duration: 28 months

22 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find the highest safe dose of hu5B1-TCO and the best dosing schedule of hu5B1-TCO and 64Cu-Tz-SarAr for finding cancer cells that are CA19-9 positive. This study will also help to find out how much radiation the body is exposed to when 64Cu-Tz-SarAr is used, and provide information on the way the body absorbs, distributes, and gets rid of 64Cu-Tz-SarAr.

Research Team

Neeta Pandit-Taskar, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Inclusion Criteria

Individuals eligible for surgery to remove tumors, biopsy or those with metastatic disease who need a biopsy before receiving standard care.

Eligible patients are those who have undergone neoadjuvant chemotherapy or radiation therapy prior to a surgical procedure.

You have an ECOG performance status between 0 and 2.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hu5B1-TCO and 64Cu-Tz-SarAr to determine the highest safe dose and best dosing schedule

28 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 64Cu-Tz-SarAr
• hu5B1-TCO

Participant Groups

Group I: Participants with Pancreatic Cancer Experimental Treatment 4 Interventions

Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+