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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I | Experimental | Up to 12 participants with tumors that are found to be >/= 50% positive for DLL3 by IHC |
|
| Phase II | Experimental | Up to 18 participants with tumors that are found to be >/= 50% positive for DLL3 by IHC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 89Zr-DFO-SC16.56 | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Subject Inclusion Criteria for Adult population
Signed, informed consent
Age 18 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 OR 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
Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for 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, as an alternative if archival tissue is not available, patients must be willing to undergo PET/CT guided biopsy3 as described in section 9.3.
Subject Inclusion Criteria for Pediatric population
Exclusion Criteria:
Subject Exclusion Criteria for the Adult population
Subject Exclusion Criteria for the Pediatric population
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark P Dunphy, DO | Contact | 212-639-8131 | dunphym@mskcc.org | |
| Charles Rudin, MD, PhD | Contact | 646-888-4527 | rudinc@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Mark P Dunphy, DO | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38950555 | Derived | 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. | |
| 35046060 |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D017321 | Clinical Trials, Phase I as Topic |
| D017322 | Clinical Trials, Phase II as Topic |
| ID | Term |
|---|---|
| D002986 | Clinical Trials as Topic |
| D000068456 | Clinical Studies as Topic |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
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| SC16.56, Phase I, Cohort 2 | Drug | 7.5mg |
|
| SC16.56, Phase I, Cohort 3 | Drug | 22.5mg |
|
| SC16.56, Phase II | Drug | Dose for Phase II will be determined by results from Phase I. |
|
| Derived |
| Tully 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. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |