PET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56
Immuno-PET Imaging of Neuroendocrine Tumors Using 89Zr-DFO-SC16.56, a DLL3-targeting Monoclonal Antibody
1 other identifier
interventional
53
1 country
1
Brief Summary
The purpose of this study is to look at how safe 89Zr-DFO-SC16.56 is, and how it is processed by the body in people with small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2019
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 11, 2019
CompletedFirst Submitted
Initial submission to the registry
December 12, 2019
CompletedFirst Posted
Study publicly available on registry
December 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 11, 2026
January 7, 2026
January 1, 2026
6.5 years
December 12, 2019
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Phase I: Radiation Dosimetry of 89Zr- DFO-SC16.56 PET/CT imaging in participants
The PET and blood data are used to quantify tracer-biodistribution, measuring the amount of radioactivity present in the blood and bodily regions-of-interest
Up to 12 months
Phase I: Safety of 89Zr- DFO-SC16.56 PET/CT imaging in cancer patients by evaluating toxicities
89Zr- DFO-SC16.56 PET/CT will be considered safe if there are no possibly probably, or definitely related grade 3 or higher toxicities (except allergic reactions) among the patients enrolled in the phase I portion
up to 12 months
Phase II: Correlation between tumor uptake of 89Zr- DFO-SC16.56 with expression of DLL3
This is determined by immunohistochemistry and quantitative mass spectrometry.
Up to 12 months
Study Arms (2)
Phase I
EXPERIMENTALUp to 12 participants with tumors that are found to be \>/= 50% positive for DLL3 by IHC
Phase II
EXPERIMENTALUp to 18 participants with tumors that are found to be \>/= 50% positive for DLL3 by IHC
Interventions
Injection of 2 mCi of 89Zr-DFO-SC16.56 for Phase I participants. Dose for Phase II will be determined by results from Phase I.
Eligibility Criteria
You may qualify if:
- Signed, informed consent
- Age 4 or more years
- Histologically confirmed, SCLC, (newly diagnosed or recurrent); small cell carcinoma of unknown or non-lung origin; or other types of neuroendocrine tumor OR
- Histologically confirmed prostate cancer, with suspected or confirmed NEPC based upon clinical assays obtained prior to the trial OR
- Histologically confirmed or suspected primary brain neoplasm
- Desmoplastic small round cell tumors, osteosarcoma, Ewing's sarcoma, rabdomyosarcoma, Wilms tumors, hepatoblastomas, rhabdoid tumors and neuroblastoma patients
- At least one tumor lesion on CT2 or MRI ≥ 0.8 cm OR
- Tumor detectable FDG PET, PSMA PET, DOTATATE PET, MIBG SPECT (or planar MIBG scan if SPECT unavailable) OR
- MRI or bone scan that shows new osseous metastases. The scans should have been obtained in the last 12 weeks
- ECOG performance status 0 to 2
- Performance Status: Subjects must have a Lansky (\<16 years of at least 40)
- Negative serum pregnancy test within 2 weeks of 89Zr- DFO-SC16.56 or women of child-bearing potential
- Available archival tumor specimen suitable for DLL3 IHC or clinician already has plans to obtain tumor specimen as part of standard of care (unrelated to patient participation in 19-292) which will yield sufficient tumor specimen to allow for DLL3 IHC
- For the prostate cancer patient cohort with only bone metastases, a recent PET scan (FDG or PSMA-targeted) that shows tracer-avid osseous metastases, a recent MRI that shows new osseous metastases, a bone scan that shows new osseous metastases, or have recent PET or SPECT scans that demonstrate tumors that are evaluable by PET or SPECT. The scans should have been obtained in the last 8 weeks.
- Patients with SCLC will be the primary study population, however patients with other types of neuroendocrine tumors may be included at the PI's discretion.
- +2 more criteria
You may not qualify if:
- History of anaphylactic reaction to humanize or human antibodies
- Pregnant or breast feeding
- Psychiatric illness that would interfere with compliance with the study procedures
- Inability to undergo PET scan due to weight limit
- Patients who require anesthesia or monitored sedation to tolerate PET scan procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Publications (2)
Tendler S, Dunphy MP, Agee M, O'Donoghue J, Aly RG, Choudhury NJ, Kesner A, Kirov A, Mauguen A, Baine MK, Schoder H, Weber WA, Rekhtman N, Lyashchenko SK, Bodei L, Morris MJ, Lewis JS, Rudin CM, Poirier JT. Imaging with [89Zr]Zr-DFO-SC16.56 anti-DLL3 antibody in patients with high-grade neuroendocrine tumours of the lung and prostate: a phase 1/2, first-in-human trial. Lancet Oncol. 2024 Aug;25(8):1015-1024. doi: 10.1016/S1470-2045(24)00249-3. Epub 2024 Jun 28.
PMID: 38950555DERIVEDTully KM, Tendler S, Carter LM, Sharma SK, Samuels ZV, Mandleywala K, Korsen JA, Delos Reyes AM, Piersigilli A, Travis WD, Sen T, Pillarsetty N, Poirier JT, Rudin CM, Lewis JS. Radioimmunotherapy Targeting Delta-like Ligand 3 in Small Cell Lung Cancer Exhibits Antitumor Efficacy with Low Toxicity. Clin Cancer Res. 2022 Apr 1;28(7):1391-1401. doi: 10.1158/1078-0432.CCR-21-1533.
PMID: 35046060DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark P Dunphy, DO
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2019
First Posted
December 16, 2019
Study Start
December 11, 2019
Primary Completion (Estimated)
June 11, 2026
Study Completion (Estimated)
June 11, 2026
Last Updated
January 7, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
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.