PET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56

January 5, 2026 updated by: Memorial Sloan Kettering Cancer Center

Immuno-PET Imaging of Neuroendocrine Tumors Using 89Zr-DFO-SC16.56, a DLL3-targeting Monoclonal Antibody

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

53

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Charles Rudin, MD, PhD
  • Phone Number: 646-888-4527
  • Email: rudinc@mskcc.org

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Mark Dunphy, DO
          • Phone Number: 212-639-8131

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Patients who meet the above inclusion and exclusion criteria will be invited to participate in the study by a designated consenting professional, which in most cases is likely to be their primary oncologist. Men and women, and all minorities will be considered for participation on an equal basis.

Description

Inclusion Criteria:

  • 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.

      1. 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. Criterion is intended to demonstrate presence of imageable disease. A low-dose CT (e.g. from a PET/CT scan) may be used at PI's discretion.
      3. While willingness to undergo the biopsy is required if archival tissue is not available, PET/CT guided biopsy is not a mandatory study assessment. As described in section 9.3, the guided biopsy may be waived at the discretion of the principal investigator if the DLL3 PET/CT reveals no sites of DLL3 tracer-avid tumor or if the principal investigator deems it is not in the best interest of the patient, according to best clinical judgement. The pediatric population would not be approached for an optional PET/CT-guided biopsy

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase I
Up to 12 participants with tumors that are found to be >/= 50% positive for DLL3 by IHC
Drug: 89Zr-DFO-SC16.56
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.
Drug: SC16.56, Phase I, Cohort 2
7.5mg
Drug: SC16.56, Phase I, Cohort 3
22.5mg
Experimental: Phase II
Up to 18 participants with tumors that are found to be >/= 50% positive for DLL3 by IHC
Drug: 89Zr-DFO-SC16.56
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.
Drug: SC16.56, Phase II
Dose for Phase II will be determined by results from Phase I.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase I: Radiation Dosimetry of 89Zr- DFO-SC16.56 PET/CT imaging in participants
Time Frame: Up to 12 months
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
Time Frame: up to 12 months
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
Time Frame: Up to 12 months
This is determined by immunohistochemistry and quantitative mass spectrometry.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Mark P Dunphy, DO, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

December 11, 2019

Primary Completion (Estimated)

June 11, 2026

Study Completion (Estimated)

June 11, 2026

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 16, 2019

Study Record Updates

Last Update Posted (Estimated)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Small Cell Lung Carcinoma

Clinical Trials on 89Zr-DFO-SC16.56

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe