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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Small Cell Lung Cancer; Small Cell Lung Carcinoma

Treatments: Drug: SC16.56, Phase I, Cohort 3; Drug: SC16.56, Phase I, Cohort 2; Drug: 89Zr-DFO-SC16.56; Drug: SC16.56, Phase II

Study type: Interventional

Funder types: Other

Identifiers

NCT04199741

19-292

Details and patient eligibility

About

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.

Enrollment: 53 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Phase I

Experimental group

Description:

Up to 12 participants with tumors that are found to be \>/= 50% positive for DLL3 by IHC

Treatment:

Drug: 89Zr-DFO-SC16.56

Drug: SC16.56, Phase I, Cohort 3

Drug: SC16.56, Phase I, Cohort 2

Phase II

Experimental group

Description:

Up to 18 participants with tumors that are found to be \>/= 50% positive for DLL3 by IHC

Treatment:

Drug: SC16.56, Phase II

Drug: 89Zr-DFO-SC16.56