Clinical trial NCT04199741: PET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56
Official title: Immuno-PET Imaging of Neuroendocrine Tumors Using 89Zr-DFO-SC16.56, a DLL3-targeting Monoclonal Antibody
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Small Cell Lung Cancer
Small Cell Lung Carcinoma
Keywords: Small cell lung cancer
Small Cell Lung Carcinoma
89Zr-DFO-SC16.56
19-292
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* 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
* At least one tumor lesion on CT or MRI \>/= 2 cm

  ° 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, or a bone scan that shows new osseous metastases. The scans should have been obtained in the last 8 weeks.
* ECOG performance status 0 to 2
* Negative serum pregnancy test within 2 weeks of 89Zr- DFO-SC16.56 or women of child-bearing potential
* Adequate organ function as assessed by
* Absolute neutrophil count (ANC) \>/= 1,500 mm\^8
* Hemoglobin \>/= 8.0 g/dL
* Platelet count \>/= 75,000/mm\^3
* Bilirubin \</= 1.5 x ULN (upper limit of the norm)
* AST (GOT) \</= 3.0 x ULN (when no liver metastases are present)
* AST (GOT) \</= 5.0 x ULN (when liver metastases are present)
* ALT (GOT) \</= 3.0 x ULN (when no liver metastases are present)
* ALT (GOT) \</= 5.0 x ULN (when no liver metastases are present)
* Creatinine \</= 1.5 x ULN
* Available archival tumor biopsy material suitable for DLL3 IHC. Archival tissue is not required to have been collected within a specific time frame relative to imaging

  * For the prostate cancer patient cohort, as an alternative if archival tissue is not available, patients must be willing to undergo PET/CT guided biopsy\*\* as described in section 9.3.

    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.

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

Primary outcomes:
measure: Phase I: Radiation Dosimetry of 89Zr- DFO-SC16.56 PET/CT imaging in participants
timeFrame: Up to 12 months
measure: Phase I: Safety of 89Zr- DFO-SC16.56 PET/CT imaging in cancer patients by evaluating toxicities
timeFrame: up to 12 months
measure: Phase II: Correlation between tumor uptake of 89Zr- DFO-SC16.56 with expression of DLL3
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mark P Dunphy, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.