RECRUITING

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

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Conditions

Pancreatic CancerPancreatic Ductal AdenocarcinomaMetastatic Pancreatic Ductal AdenocarcinomaPrimary Pancreatic Ductal AdenocarcinomaMetastatic Pancreatic Cancerhu5B1-TCO64Cu-Tz-SarAr20-409Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I Study of Pretargeted PET Imaging Using 64Cu-Tz-SarAr and a Trans-Cyclooctene-Modified Humanized 5B1 Immunoconjugate (hu5B1-TCO) in Patients With Pancreatic, Bladder Cancer, Gastrointestinal Malignancies or Solid Tumors With Elevated CA19-9

Quick Facts

Study Start:2023-02-10
Study Completion:2025-02-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05737615

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Signed informed consent
  2. 2. 18 years of age or older
  3. 3. Histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma/bladder carcinoma / gastrointestinal tumor reviewed at MSK - includes patients with biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (PDAC) or histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) of
  4. 4. At least one lesion by CT or MRI ≥ 2 cm unless determined otherwise for presurgery subjects 5. ECOG performance status of 0 to 2 6. Adequate laboratory parameters including: i. Absolute neutrophil count (ANC) ≥1.5 x 109/L ii. Hemoglobin ≥ 9.0 g/dL iii. Platelet count \>75,000/ mm3 iv. AST/SGOT, ALT/SGPT ≤2.5 x ULN, unless liver metastases are clearly present, then ≤5.0 x ULN v. Total bilirubin ≤ 1.5x the upper limit of normal unless considered due to Gilbert's syndrome in which case, ≤3x the upper limit of normal vi. Creatinine clearance (CLcr) (\> 60 mL/min) estimated by the Cockcroft-Gault (C-G) equation or estimated glomerular filtration rate (eGFR) 10. Willingness to participate in collection of pharmacokinetic samples
  1. 1. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  2. 2. Major surgery other than diagnostic surgery within 4 weeks of Study Day 1
  3. 3. History of anaphylactic reaction to human, or humanized, antibody
  4. 4. Other on-going cancer therapy with investigational agents
  5. 5. Known history of HIV
  6. 6. Pregnant or currently breast-feeding
  7. 7. Psychiatric illness/social situations that would interfere with compliance with study requirements.

Contacts and Locations

Study Contact

Neeta Pandit-Taskar, MD
CONTACT
2126393046
pandit-n@MSKCC.ORG
Eileen O'Reilly, MD
CONTACT
6468884182
oreillye@MSKCC.ORG

Principal Investigator

Neeta Pandit-Taskar, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Neeta Pandit-Taskar, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-10
Study Completion Date2025-02-10

Study Record Updates

Study Start Date2023-02-10
Study Completion Date2025-02-10

Terms related to this study

Keywords Provided by Researchers

  • Pancreatic Cancer
  • Pancreatic Ductal Adenocarcinoma
  • Metastatic Pancreatic Ductal Adenocarcinoma
  • Primary Pancreatic Ductal Adenocarcinoma
  • Metastatic Pancreatic Cancer
  • hu5B1-TCO
  • 64Cu-Tz-SarAr
  • 20-409
  • Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

  • Pancreatic Cancer
  • Pancreatic Ductal Adenocarcinoma
  • Metastatic Pancreatic Ductal Adenocarcinoma
  • Primary Pancreatic Ductal Adenocarcinoma
  • Metastatic Pancreatic Cancer