89Zr-DFO-SC16.56 Imaging for Small Cell Lung Cancer

Overseen By Charles Rudin, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Anaphylactic reaction, Pregnant, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

53 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new imaging technique using 89Zr-DFO-SC16.56, an experimental imaging agent, to assess its function and safety in individuals with small cell lung cancer (SCLC). The study aims to determine how this substance aids in detecting cancer cells. Suitable participants include those with SCLC or certain other neuroendocrine tumors, with at least one tumor visible in scans such as CT or MRI. As a Phase 1 trial, the research focuses on understanding the treatment's effects in humans, providing participants the opportunity to be among the first to receive this new imaging agent.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that 89Zr-DFO-SC16.56 is likely to be safe for humans?

A previous study found 89Zr-DFO-SC16.56 to be safe and well-tolerated for imaging. Patients experienced no unexpected medical issues after using this treatment. Vital signs and lab results showed no significant changes, indicating the treatment did not cause noticeable health problems. This research suggests that the body handles 89Zr-DFO-SC16.56 well, allowing its safe use in people with small cell lung cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about 89Zr-DFO-SC16.56 for small cell lung cancer because it offers a novel way to visualize tumors using PET/CT imaging. Unlike other treatments that primarily aim to shrink or eliminate tumors, this approach uses a radioactive tracer to specifically target DLL3, a protein commonly overexpressed in these cancer cells, allowing for precise imaging. This method could potentially enhance the accuracy of diagnosis and monitoring, giving doctors a clearer picture of the cancer's progression and response to treatment.

What evidence suggests that 89Zr-DFO-SC16.56 might be an effective treatment for small cell lung cancer?

Research has shown that 89Zr-DFO-SC16.56 could help detect cancers with DLL3, a protein found in some tumors. One study successfully identified DLL3-expressing tumors in 80% of patients. This method might help doctors see where cancer has spread in the body. Participants in this trial will receive 89Zr-DFO-SC16.56 to evaluate its effectiveness and safety. It has been used safely in other patients, suggesting it could benefit those with small cell lung cancer. However, more research is needed to confirm its effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

Mark P Dunphy, DO

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Signed, informed consent

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Participants receive 89Zr-DFO-SC16.56 PET/CT imaging to assess radiation dosimetry and safety

Up to 12 months

Phase II Treatment

Participants receive 89Zr-DFO-SC16.56 PET/CT imaging to correlate tumor uptake with DLL3 expression

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 89Zr-DFO-SC16.56

How Is the Trial Designed?

Group I: Phase II Experimental Treatment 2 Interventions

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

Group II: Phase I Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10802659/

First-in-human imaging with [89Zr]Zr-DFO-SC16.56 anti- ... These results demonstrate the potential utility of [89Zr]Zr-DFO-SC16. 56 for non-invasive in vivo detection of DLL3-expressing malignancies.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e15057

Imaging with [89Zr]Zr-DFO-SC16.56 anti-DLL3 antibody in ... DLL3 PETCT imaging of patients with NEPC is safe and feasible. These results show the potential utility of [ 89 Zr]Zr-DFO-SC16.56 for non-invasive in vivo ...

3. asco.org asco.org/abstracts-presentations/ABSTRACT481560

Imaging with [89Zr]Zr-DFO-SC16.56 anti-DLL3 antibody in ... Tumoral uptake by [89Zr]Zr-DFO-SC16.56 was associated with protein expression in 8 (80%) of 10 patients who had DLL3 IHC performed. None of the patients had any ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04199741

NCT04199741 | PET/CT Imaging of Small Cell Lung ... 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.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1040842824002671

DLL3 as a potential diagnostic and therapeutic target in ... In patients with DLL3-positive neoplasms, no differences were found in 5-year OS (58.3 % vs 35.7 %; p = 0.36) or 5-year recurrence-free survival (RFS) (41.7 % ...

6. synapse.patsnap.com synapse.patsnap.com/drug/2f0de2d51f134534a1dd7ffd47ce0721

89Zr-DFO-SC16.56 - Drug Targets, Indications, Patents Tumour uptake by [89Zr]Zr-DFO-SC16.56 was congruent with DLL3 immunohistochemistry in 15 (94%) of 16 patients with evaluable tissue. Two patients with non-avid ...