Recruiting NCT04199741

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

Phase I / Phase II Interventional Small Cell Lung Cancer Small Cell Lung Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: 89Zr-DFO-SC16.56, SC16.56, Phase I, Cohort 2, SC16.56, Phase I, Cohort 3, SC16.56, Phase II.
Who it may be relevant to: Registry conditions: Small Cell Lung Cancer, Small Cell Lung Carcinoma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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.

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
Drug SC16.56, Phase II
Dose for Phase II will be determined by results from Phase I.

Phase I: Radiation Dosimetry of 89Zr- DFO-SC16.56 PET/CT imaging in participants [Time frame: 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]
Phase II: Correlation between tumor uptake of 89Zr- DFO-SC16.56 with expression of DLL3 [Time frame: Up to 12 months]

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.

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.
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.
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 itis 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

Subject Inclusion Criteria for Pediatric population

Signed, informed consent
Age 4 or more years
High risk 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 for women of child-bearing potential

Subject Exclusion Criteria for the Adult population

History of anaphylactic reaction to humanized 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

Subject Exclusion Criteria for the Pediatric population

History of anaphylactic reaction to humanized 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

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) PMID 38950555
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. PMID 35046060

NCT: NCT04199741 · 19-292