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

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04199741
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 11, 2019
Status verified
Jan 2026
Primary completion
Jun 11, 2026
Completion
Jun 11, 2026

Study Design

Enrollment
53 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Phase I
    Up to 12 participants with tumors that are found to be \>/= 50% positive for DLL3 by IHC
  • Experimental: Phase II
    Up to 18 participants with tumors that are found to be \>/= 50% positive for DLL3 by IHC

Primary Outcome Measure

Phase I: Radiation Dosimetry of 89Zr- DFO-SC16.56 PET/CT imaging in participants [ Time Frame: Up to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Mark Dunphy, DO
212-639-8131

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