Pancreatic CancerPhase 1NCT05737615
PET Imaging Using 64Cu-Tz-SarAr and hu5B1-TCO in People With Pancreatic, Colorectal, Bladder Cancer or Cancers With Elevated CA19.9
A Phase 1 study testing PET Scan, hu5B1-TCO and 64Cu-Tz-SarAr in people with Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma
- What is being tested?
- PET Scan, hu5B1-TCO and 64Cu-Tz-SarAr
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2023to 7 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be eligible for enrollment if they fulfill the following criteria:
- Signed informed consent
- 18 years of age or older
- 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
- Patient with solid tumors increased serum CA19-9 serum level greater than ULN or CA19-9 positive biopsy
- 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
Who cannot join
- Patients will be excluded from the study if they fulfill any of the following criteria:
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Major surgery other than diagnostic surgery within 4 weeks of Study Day 1
- History of anaphylactic reaction to human, or humanized, antibody
- Other on-going cancer therapy with investigational agents
- Known history of HIV
Show all 9Show fewer
- Pregnant or currently breast-feeding
- Subjects and their partners with reproductive potential must agree to use an effective form of contraception during the study and for 1 week following the study treatment.
- Psychiatric illness/social situations that would interfere with compliance with study requirements.
About this study
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
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.
- Conditions
- Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Primary Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer
- Being tested
- PET Scan, hu5B1-TCO, 64Cu-Tz-SarAr, Pharmacokinetics
- Keywords
- 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
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET ScanDiagnostic test
Participants will be imaged up to 4 time points post-injection to allow for biodistribution and dosimetry determination
hu5B1-TCODrug
On study day 0, a single slow infusion of hu5B1-TCO will be administered intravenously. Subsequently, either 3 days (n = 3) or 5 days (n = 3) later, a single slow infusion of 64Cu-Tz-SarAr will be administered intravenously.
64Cu-Tz-SarArDrug
On study day 0, a single slow infusion of hu5B1-TCO will be administered intravenously. Subsequently, either 3 days (n = 3) or 5 days (n = 3) later, a single slow infusion of 64Cu-Tz-SarAr will be administered intravenously.
PharmacokineticsDiagnostic test
All participants receiving 64Cu-Tz-SarAr will have serial blood samples drawn.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Pancreatic Cancer | Experimental | Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma Receives: Diagnostic Test: PET Scan; Drug: hu5B1-TCO; Drug: 64Cu-Tz-SarAr; Diagnostic Test: Pharmacokinetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV mean measurement
The serial quantitative data obtained over the various organs of interest (heart, liver, spleen, kidney, lung and any other organ that exhibits uptake) will be collected
Measured: 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start10 Feb 2023
- Primary completion7 Aug 2026
- Study completion7 Aug 2026
Why it stopped: Study tracer is currently unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Somali Gavane, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737615
- Sponsor's protocol ID
- 20-409
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05737615
- Acronym / sponsor ID
- 20-409
- Conditions
- Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Primary Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Primary Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, hu5B1-TCO, 64Cu-Tz-SarAr, 20-409
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study tracer is currently unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 7 Aug 2026 (actual)
- Study completion
- 7 Aug 2026 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Pancreatic Cancer | Experimental | Diagnostic Test: PET Scan, Drug: hu5B1-TCO, Drug: 64Cu-Tz-SarAr, Diagnostic Test: PharmacokineticsParticipants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent
- 18 years of age or older
- 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
- Patient with solid tumors increased serum CA19-9 serum level greater than ULN or CA19-9 positive biopsy
- 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
Key exclusion criteria (9 listed)
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Major surgery other than diagnostic surgery within 4 weeks of Study Day 1
- History of anaphylactic reaction to human, or humanized, antibody
- Other on-going cancer therapy with investigational agents
- Known history of HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET ScanParticipants will be imaged up to 4 time points post-injection to allow for biodistribution and dosimetry determination | Diagnostic test | Participants with Pancreatic Cancer |
| hu5B1-TCOOn study day 0, a single slow infusion of hu5B1-TCO will be administered intravenously. Subsequently, either 3 days (n = 3) or 5 days (n = 3) later, a single slow infusion of 64Cu-Tz-SarAr will be administered intravenously. | Drug | Participants with Pancreatic Cancer |
| 64Cu-Tz-SarArOn study day 0, a single slow infusion of hu5B1-TCO will be administered intravenously. Subsequently, either 3 days (n = 3) or 5 days (n = 3) later, a single slow infusion of 64Cu-Tz-SarAr will be administered intravenously. | Drug | Participants with Pancreatic Cancer |
| PharmacokineticsAll participants receiving 64Cu-Tz-SarAr will have serial blood samples drawn. | Diagnostic test | Participants with Pancreatic Cancer |
Primary outcome
SUV mean measurement
Time frame: 28 months
The serial quantitative data obtained over the various organs of interest (heart, liver, spleen, kidney, lung and any other organ that exhibits uptake) will be collected
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Somali Gavane, MD principal investigator
Memorial Sloan Kettering Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PET Scan, hu5B1-TCO and 64Cu-Tz-SarAr in people with Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUV mean measurement (time frame: 28 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.